Guidelines for Responsible Data Management in Scientific Research

Developed by:

Funded by:
Office of Research Integrity US Department of Health and Human Services

About the Course

Data management is one of the essential areas of responsible conduct of research, as outlined by the Office of Research Integrity. This educational course will educate new investigators about conducting responsible data management in scientific research. Researchers who are considering submitting a federal grant or contract for the first time can also benefit from this introductory course on data management, as can other research team members. The course includes background information about the topic, best practice guidelines, various learning features, and a resource section. Learning Objectives After taking the course, learners will be able to nderstand the general rules of appropriate data management in accordance with responsible conduct of research nderstand how to define roles and responsibilities of research staff regarding data management Develop and implement a communication plan for dealing with data management issues among the research team tili!e the information featured in the course to implement a system for conducting responsible data management Online Version This course was previously available on the Internet at http"##www.R$R%ducation.com. The website is not active at this time. &eghan '. $oulehan, &() *onathan +. ,ells, 'A

Development of this website was funded by the Office of Research Integrity -ORI. Responsible $onduct of Research Resource Development (rogram.

+eel free to contact us with comments or /uestions. 0ou can reach (ro1ect Director, &eghan $oulehan, at coulehan2clinicaltools.com.

Introduction
Data management is one of the core areas addressed by the Office of Research Integrity "ORI# in its responsible conduct of research initiative "see links in sidebar#. This important, multifaceted issue affects all health researchers and deserves e3tra attention and diligence. Oversight of data management represents a significant investment of time and effort by the *rincipal Investigator "*I# of a research pro1ect. -or oversight to be thorough and correct, *Is must understand the basic concepts of data management and ensure that every member of the research pro1ect team is involved in the planning, implementation, and maintenance of data management policies and procedures. Data management is one of 4 core areas addressed by the Office of Research Integrity5s responsible conduct of research initiative.

To learn more about the ORI or the responsible conduct in research initiative, check out the following links$

6 Department of +ealth and +uman 6ervices5 ORI website 7http$%%www.ori.dhhs.gov% 8 ORI5s Introduction to the Responsible &onduct of Research 7http$%%www.ori.dhhs.gov% documents%rcrintro.pdf8

Overview: Concepts of Data Management

)efore starting a new scientific research pro1ect, the *I and research team must address issues related to data management, including the following$ e! Concept Data Ownership "ow It #elates to #esponsible Conduct of #esearch This pertains to who has the legal rights to the data and who retains the data after the pro1ect is completed, including the *I5s right to transfer data between institutions. This pertains to collecting pro1ect data in a consistent, systematic manner "i.e., reliability# and establishing an ongoing system for evaluating and recording changes to the pro1ect protocol "i.e., validity#. This concerns the amount of data that should be stored 99 enough so that pro1ect results can be reconstructed. This relates to protecting written and electronic data from physical damage and protecting data integrity, including damage from tampering or theft. This refers to the length of time one needs to keep the pro1ect data according to the sponsor5s or funder5s guidelines. It also includes secure destruction of data. This pertains to how raw data are chosen, evaluated, and interpreted into meaningful and significant conclusions that other researchers and the public can understand and use. This concerns how pro1ect data and research results are disseminated to other researchers and the general public, and when data should not be shared. This pertains to the publication of conclusive findings, both positive and negative, after the pro1ect is completed. It is important for researchers to understand how data management issues relate to the responsible conduct of research.

Data Collection

0ou can print out the worksheet version of this page to share with your entire research team. This worksheet is included at the end of the document.

Data $torage

Data %rotection

Data #etention

Data Anal!sis

Data $haring

Data #eporting

(6teneck, :;;<# The pages that follow will provide more in9depth descriptions of each of these terms and will e3plain how each one relates to the responsible conduct of research.

&hin' Ahead (ui): *hat Are Data+

&rue or ,alse: In scientific research, only the information and observations that are made as part of scientific in/uiry are considered data. ==True ==-alse

Answer: -alse. In fact, data also include the materials, products, procedures, and other data sources that are part of the research pro1ect. 'ssentially, data are considered to be anything and everything that informs the way in which individuals are able to understand and to process their world. Read on to learn more.

Defining Data
)efore reviewing the concepts of data management, the term data should be defined. The (erriam9.ebster Dictionary ":;;># defines data as ?factual information "as measurements or statistics# used as a basis for reasoning, discussion, or calculation.? According to this definition, some e3amples of types of medical research data would include the following$

Data are any information or observations that are associated with a particular pro1ect, including e3perimental specimens, technologies, and products related to the in/uiry.

*atient survey responses .hite blood cell counts &ore temperature readings (etabolism rates

+owever, data can also refer to any observations that are made 99 such as a patient5s symptoms or a population5s health habits. Other ,orms of Data Data are not only the information and observations made as part of scientific in/uiry but also the materials, the means, and the products of that in/uiry "these are sometimes called data sources#. In other words, data can also include the following$

Tissue samples 6pecially designed primers *atient /uestionnaires Interviews &ustomi!ed online content

Case Vignette: Data Ownership

Dr. 6mith works at The niversity and is the *rincipal Investigator on a large research pro1ect that is funded by the @ational Institutes of +ealth "@I+#. +owever, while Dr. 6mith wrote the original grant proposal, he does very little day9to9day work on the pro1ect. Instead, the Research Director, )etsy, oversees all aspects of the pro1ect, including staff supervision and all data management activities. In addition, )etsy has been lead author on several publications about the pro1ect5s research findings. *ho owns the project and its data+ == The *I, Dr. 6mith == The Research Director, )etsy == The niversity == The @ational Institutes of +ealth == @o one person or organi!ation Answer: The niversity. Despite the *I5s and the Research Director5s work on the pro1ect, the sponsoring institution typically maintains ownership of a pro1ect5s data as long as the *I submitted the grant through that institution and is employed by them. +owever within the sponsoring institution, a *I is generally granted stewardship over the pro1ect dataA he%she may control the course, publication, and copyright of any research, sub1ect to institutional review. Read on to learn more about data ownership.

Data Ownership
nderstanding data ownership, who can possess data, and who can publish books or articles about it are often complicated issues, related to /uestions of pro1ect funding, affiliations, and the sources and forms of the research itself. -or federally funded research, ownership of data involves at least B different entities$ the sponsoring institution, the funding agency, and the *I. In many cases, the institution%organi!ation owns the pro1ect data, but the *I and the funding agency have ?rights? to access and use the data. sually the *I has physical custody of the data on behalf of the organi!ation. +owever, these rules vary by institution and depending on the funding source. 6ome general guidelines are presented below$ -. &he $ponsoring Institution/ e.g., a university or a research firm (ost often, the sponsoring institution%organi!ation maintains ownership of a pro1ect5s data as long as the *I is employed by that institution. The institution often controls all funding or the disbursement of government fundingA conse/uently, it is also responsible for ensuring that funded research is conducted responsibly and ethically. .ithin the sponsoring institution, a *I is granted stewardship over the pro1ect dataA the *I may control the course, publication, and copyright of any research, sub1ect to institutional review. 0. &he ,unding Agenc!, e.g., @I+ or the &enters for Disease &ontrol and *revention "&D&# (any research pro1ects are funded by federal government agencies, philanthropic organi!ations, or private industries. These agencies often have specific stipulations for how data will be retained and disseminated$ for e3ample, they decide whether to publish the pro1ect5s results or market a resulting product, rather than the *I. The *I and institution should understand his or her funding agency5s regulations regarding a research pro1ect and the data it produces. @ote that re/uirements for federal grants may be different than government contracts "discussed further on the ne3t page#. 1. &he %rincipal Investigator In addition to being the steward of a pro1ect5s data, a *I may retain some ownership of the data. In small businesses, it is assumed that rights and ownership of data remain with the business itself or with the funding agency, unless otherwise stipulated. In academic institutions, however, *Is are sometimes allowed to take their research and its data with them if they change research institutions. (any universities have offices and policies in place to ensure that such a transfer of data respects both the rights of the researcher and those of the institution"s#. " 6D++6, C44;# $ubjects2 #ights to Ownership It is also important to consider data ownership from the perspective of individuals who suggest research ideas and%or participate in the research. 6ome research sub1ects are e3pressing a desire for partial ownership or control of research in which they have participated. -or instance, in : recent court cases, the defense contended that research institutions had improperly benefited in e3tending their study5s implications beyond any consent that the participating sub1ects had given. "6ee sidebar for links to read more.# 6ince human sub1ects are often sources for data that may be otherwise unavailable to researchers, it is important to consider study participants5 beneficence and dignity in relation to the pro1ect5s progress and goals. Data ownership refers to the control and rights over the data as well as data management and use. Ownership of research is a comple3 issue that involves the *I, the sponsoring institution, the funding agency, and any participating human sub1ects.

The )ayh9Dole Act of C4D; allows universities to obtain patents for inventions made with federal funding and to work directly with industry to commerciali!e these products. If you would like to learn more about the act5s development and results thus far, follow this link to learn more about the )ayh9Dole Act.7http$%%www.ucop.edu% ott%bayh.html8 If you would like to learn more about the difference between government contracts and government grants, follow this link to learn about government funding through the @I+. 7http$%%grants.nih.gov%grants% funding%contracts=vs=grants. +tm8 If you would like to learn more about how research sub1ects have challenged data ownership and their own role in research, read the article ?.ho Owns 0our EenesF? from the @ew 0ork Times. 7http$%%www.nytimes.com%librar y%national%science%health%;>C>; ;hth9aids9gene.html8

%op up %age: 3rants Versus Contracts

(uch of scientific research financing from federal agencies, such as the -ood and Drug Administration "-DA# or the @I+, is in the form of grants. -or instance, 4>G of awards that are made through @I+5s 6mall )usiness Innovation Research "6)IR# program are grants, and the remaining >G are contracts. 6o, what is the difference between government grants and contractsF 3overnment 3rants Eovernment grants can be described as assistance funding. Erants are usually awarded to research pro1ects that are deemed to be ?good science,? i.e., pro1ects that increase our understanding of new or established theories or that further research. .ith a grant, the *I retains control over the scope of the research and makes decisions about how the funding will be spent. 3overnment Contracts Eovernment contracts can be described as procurement funding$ that is, the government is providing money in order to ac/uire a product, property, or service. Hike a contractual agreement between a buyer and a seller, government9 contracted research is often sub1ect to strict regulations, re/uirements, and e3pectations. -or instance, the *I must coordinate pro1ect goals and decisions with the funding agency, which assigns a pro1ect officer to oversee the pro1ect and to make sure that the agency5s goals are being met. -unding may be distributed in installments, contingent upon the funder5s satisfaction with pro1ect progress reports. Also, the data typically belong to the funding agency, unless otherwise stipulated in the initial contract.

&hin' Ahead (ui): Data Collection

Data that are collected as part of a scientific research project ultimatel! prove or disprove the %I2s h!potheses and justif! a bod! of research to the public at large. *hich statement is true about data collection in scientific research+

== 'nsuring validity of the data is the key to successful research. == 'nsuring reliability of the data is the key to successful research. == 'nsuring reliability and validity are e/ually important. == Data collection is actually not a key part of scientific research, since many researchers use previously collected data. Answer: 'nsuring reliability and validity are e/ually important. 'nsuring reliability and validity of the data are e/ually important during data collection. .hen data collection is carried out according to these : rules, researchers will be able to accurately assess, replicate, and disseminate their results. Read on to learn more.

Data Collection
Data collection refers not only to what information is recorded and how it is recorded, but also to how a particular research pro1ect is designed. Although data collection methodology varies by pro1ect, the aim of successful data collection should always be to uphold the integrity of the pro1ect, the institution, and the researchers involved. Data collection may seem tedious or repetitive, but the data produced in research ultimately prove or disprove hypotheses and 1ustify or counter a body of research. In addition, thorough data collection accomplishes the following$

Data collection provides the information necessary to develop and 1ustify research. A successful pro1ect collects reliable and valid data.

'nables those involved in the research to more accurately analy!e and assess their work Allows independent researchers to replicate the process and evaluate results Impresses upon research team members the importance of data management Details the rationale behind a research pro1ect *rovides 1ustification to sponsors for e3penditures and pro1ect decisions 0ields reliable and valid results, and hypothesis testing

0ou can print out the worksheet version of this page to help track your data collection activities. This worksheet is included at the end of the document.

Collecting #eliable Data

Data collection guidelines and methodologies should be carefully developed before the research begins. The researchers must determine what sort of data will be collected and how this data will be analy!ed. -or data to be considered reliable, data collection should occur consistently and systematically throughout the course of the pro1ect. &he Importance of %lanning for Data Collection Team members who will collect data should be thoroughly trained to ensure consistency in data collection. )y collecting data in a well9planned, systematic manner, team members will be able to answer any /uestion about a pro1ect, including the following$

Data collection is reliable when it is employed in a consistent and comprehensive manner throughout the course of a pro1ect. Thorough data collection enables research team members to answer any /uestion about a pro1ect.

The purpose behind the research The particular methodologies chosen The implementation of these methodologies +ow data that were collected and analy!ed If une3pected results or significant errors were encountered The implications of the research and future directions

A clear and comprehensive account of a pro1ect and its purpose and direction make it much easier for research to be disseminated, understood, and evaluated by other members of the scientific community.

-or most research pro1ects, data collection procedures are usually described briefly in grant or contract proposals. +owever, researchers should take the time to further define each element of data collection, including specific methodologies and plans for analysis, after receiving funding but before starting the pro1ect.

Case Vignette: Collecting Valid Data

*art of the data collection methodology for Dr. 6mith5s study includes distributing a C:9page self9administered /uestionnaire to participantsA they must fill out and initial each page of the /uestionnaire to confirm completion. One day on his way home from conducting an interview with a sub1ect, the Research Assistant, ,oel, needed to write directions for a friend and he reached in his bag and grabbed the first piece of paper that he could find. ,oel accidentally ripped the back page off of one of the completed /uestionnaires to write the directions, which he then gave to his friend. +e didn5t reali!e this until a few hours later, when he was reviewing the data that he had collected that day. ,oel thought that he remembered the participant5s answers on the last page of the survey, since they were mostly demographic /uestions. *hat should 4oel do+ == 6taple on a new page and fill out the sub1ect5s responses, since he remembers them. == &ontact the sub1ect and ask her to complete the last page of the /uestionnaire again. == Omit the participant5s /uestionnaire from the study, his%her partial data is invalid. == ,ust pretend like he doesn5t know what happened to the last page. Answer: Omit the participant5s /uestionnaire from the study, his%her partial data is invalid . This is ,oel5s best option 9 if he were to attempt to collect the data again from the sub1ect, the sub1ect would be responding in a different time and mood than when the original interview occurred. As part of responsible data management, honesty about the mishap is the best way to maintain the validity of the data and to clarify that the data were not tampered with or falsified in any way. Read on to learn more about collecting valid data.

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Collecting Valid Data

&ollecting valid data ensures that when research is evaluated it will be deemed good science 99 meaning that the research is both precise and honest. Thorough data collection should thus include a continuous system for rigorously evaluating effective or deficient elements in the pro1ect protocol or the research team5s techni/ues. #ecord eeping .hen data are actually collected, the records should attempt to accurately represent the progress of a pro1ect and answer such /uestions as what, how, and why data were collected or amended. Records should be durable and accessible but safe from tampering or falsification. -or smaller pro1ects, bound notebooks provide a convenient way for all research team members to keep track of data and daily activities of a pro1ect. .hen keeping written records, errors should be marked and dated but never erased. This way, they can provide a /uick visual account of any changes or errors that have occurred. A downside of written records is that searching for a specific fact or trying to compare observations from several sources can be difficult. Also, maintaining handwritten records is not possible for larger pro1ects such as clinical trials or epidemiological surveys. (ore best practice tips for record keeping are provided on the ne3t page. 5lectronic #ecords 'lectronic records allow researchers to efficiently access and compare information from different sources and across similar pro1ects. There are numerous electronic data capture programs that allow researchers to enter, store, and audit research data. +owever, security of electronic records is a significant concern, although there are methods for protecting electronic records "discussed later in this course#. In addition, it may be time consuming and may not be cost effective for large ongoing pro1ects to migrate their data records to electronic files. Therefore, most pro1ects employ a combination of written and electronic record keeping to balance the risks and benefits. Attention to %olic! and %rocedure In addition to record keeping, the validity of the data collected can also be affected by whether or not proper policies and procedures for research are followed on a pro1ect and an individual level. One should be constantly aware of all the guidelines that might apply to the pro1ect5s implementation and dissemination, including special regulations that involve human and animal sub1ects, ha!ardous materials, or other controlled biological agents. 'very research team member should be aware of pro1ect guidelines and standards for collecting valid data, to ensure consistency throughout the pro1ect. 6ee the sidebar for more information and relevant links. -ollow this link to read the @I+5s )ioethics Resources page on +uman 6ub1ects Research and Internal Review )oards "IR)#. 7http$%%www.nih.gov%sigs%bioet hics%IR).html8 Animal #esearch $tandards -ollow this link to learn about various guidelines and issues involved in animal research from the Institute for Haboratory Animal Research. 7http$%%dels.nas.edu% ilar=n%ilarhome%8 -ollow this link to view an e3ample of an -DA9approved protocol for testing the safety of food ingredients in animals. 7http$%%www.cfsan.fda.gov% GJ'dms%opa9pt>D.html8 Diligent record keeping is essential to ensure the validity of data. (any research pro1ects keep both written and electronic records in order to balance the benefits of each.

"uman $ubjects #esearch $tandards -ollow this link to read the 6 Department of +ealth and +uman 6ervice5s " 6D++6# )asic ++6 *olicy for *rotection of +uman 6ub1ects. 7http$%%www.hhs.gov%ohrp%hu man sub1ects%guidance%<>cfr<I.htm 8

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%op up %age: 6est %ractice &ips 7 #ecord eeping

Diligent record keeping is essential to ensuring the integrity of research data. To help maintain data validity and reliability, consider these tips when planning or completing data collection$ Include notes: 0our records should allow you not only to account for what occurred during the course of research but also to reconstruct and 1ustify your findings. It is important that records include notes about what methods did or did not work, observations, and commentary on the pro1ect5s progress. Keep notes according to the research team5s predetermined communications plan.

%ersonal noteboo's: -or smaller pro1ects using handwritten data, each team member should have his or her own personal notebook for recording pro1ect data, observations, etc. 'ntries should be made in a chronological and consistent manner 99 for instance, each new workday should begin on a new page. Try not to leave blank lines between entries. 8oting errors: se a consistent system for noting errors or ad1ustments. In written records, make entries in indelible pen so that records cannot be altered or damaged. If information needs to be changed or amended, mark through the entry with one solid line and initial and date the change. The records can thus reflect what has occurred during the course of a pro1ect. #ecording information: Record anything that seems relevant to the pro1ect, its data, and the standards of the pro1ect. At a minimum, records should include the following information$

date and time names and roles of any team members who worked with the data materials, instruments, and software used identification number"s# to indicate the sub1ect and%or session data from the e3periment and any pertinent observations from the data5s collection

It may also be helpful to include a summary of the day5s data collection activities and a task list for the ne3t day.

&ransferring information: .hen transferring records from written to electronic format, use a double entry system to reduce rates of incorrectly entered electronic data. To implement such a system, have two different Research Assistants enter all of raw data into the software program, then cross9check the data to identify and remedy inconsistencies at the time of data entry. se our printable worksheet to help track your data collection and entry activities. This handout is included at the end of the document.

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Data $torage
Once data have been collected and recorded, the ne3t concern is data storage. Data storage is crucial to a research pro1ect for the following reasons$ *roperly storing data is a way to safeguard your research investment.

Data may need to be accessed in the future to e3plain or augment subse/uent research. Other researchers might wish to evaluate or use the results of your research. 6tored data can establish precedence in the event that similar research is published. 6toring data can protect research sub1ects and researchers in the event of legal allegations.

6toring data safeguards your research and your research investment. 6torage allows future access to the data in order to re9create the findings, augment subse/uent research, or establish a precedent. 'nough data should be stored so that a pro1ect and its findings can be reconstructed with ease.

&!pe and Amount of Data to #etain Eenerally speaking, enough data should be retained so that the findings of a pro1ect can be reconstructed with ease. .hile this does not mean that a pro1ect needs to retain all the raw data that were collected, relevant statistics and analyses from this data should be saved, along with any notes or observations. -urthermore, if research involves the use of biological specimens, care should be taken to retain them until their /uality degrades. 5lectronic Data The key issues for electronic data storage are thorough documentation to allow data to be appropriately used in the future and storage format that is easily adaptable to evolving computer hardware and software. There are some additional considerations that are uni/ue to electronic data storage, including the following$

Rapid access to the data -ast read%write rates How cost Ability to archive the data Removability A backup system, such as storing data on &Ds

"6traub, :;;<#

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&hin' Ahead (ui): Data %rotection

*ith the recent emergence of electronic databases/ more scientific researchers are storing their data on their computer networ's. "owever/ data protection is an issue for both paper7 and computer7based data. $o what is the best wa! to protect data+

== 6trip identifiers from human sub1ects data. == Himit who has access to the data. == se an encrypted password system and assign new passwords /uarterly. == Destroy the written data after transferral to an electronic database. Answer: Himit who has access to the data. This is the best way to protect data. 6imple measures 99 like keeping written data in a locked filing cabinet for which there is only one key 99 will help minimi!e the chance that data could be corrupted or stolen. +owever, this is a comple3 issue and employing a multifaceted security approach is the best way to ensure that your data is protected. Read on to learn more.

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Data %rotection
In order to maintain the integrity of stored data, pro1ect data should be protected from physical damage as well as from tampering, loss, or theft. This is best done by limiting access to it. *Is should decide which pro1ect members are authori!ed to access and manage the stored data. @otebooks or /uestionnaires should be kept together in a safe, secure location away from public access, e.g., a locked file cabinet. *rivacy and anonymity can be assured by replacing names and other information with encoded identifiers, with the encoding key kept in a different secure location. ltimately, the best way to protect data may be to fully educate all members of the research team about data protection procedures. "ow Can Data 6e %rotected+ Theft and hacking are particular concerns with electronic data. (any research pro1ects involve the collection and maintenance of human sub1ects data and other confidential records that could become the target of hackers. In a recent e3ample, thousands of personal information and identification records were 1eopardi!ed when hackers infiltrated systems at the niversity of &alifornia twice in :;;> " T)T6&, :;;>#. The costs of reproducing, restoring, or replacing stolen data and the length of recovery time in the event of a theft highlight the need for protecting the computer system and the integrity of the data "Kramer et al., :;;<#. 'lectronic data can be protected by taking the following precautions$

Data protection should be a part of every pro1ect5s plan for data storage. The best way to protect data, whether in written or electronic form, is by limiting access to the data. 'lectronic data storage offers many benefits but re/uires additional consideration and safeguards.

%rotecting access to data

se uni/ue user IDs and passwords that cannot be easily guessed. &hange passwords often to ensure that only current pro1ect members can access data. *rovide access to data files through a centrali!ed process. 'valuate and limit administrator access rights. 'nsure that outside wireless devices cannot access your system5s network. Keep updated anti9virus protection on every computer. (aintain up9to9date versions of all software and media storage devices. If your system is connected to the Internet, use a firewall. If your system is connected to the Internet, use intrusion detection software to monitor access. Record the original creation date and time for files on your systems. se encryption, electronic signatures, or watermarking to keep track of authorship and changes made to data files. Regularly back up electronic data files "both on and offsite# and create both hard and soft copies. 'nsure that data are properly destroyed.

%rotecting !our s!stem

6ocial engineering is a form of computer hacking in which individuals try to gain unauthori!ed access to computer systems and%or data in order to steal or corrupt information. Research team members need to be educated about social engineering and the importance of keeping passwords private, logging out of protected databases, and so forth.

%rotecting data integrit!

&hird7%art! Data %rotection (any research institutions have offices for information technology that work with the *I to assess the pro1ect5s needs and develop a data protection protocol. -or *Is without such an office, contracting with an outside information technology firm or hiring a pro1ect member to specifically focus on data protection and maintenance may be necessary. -inally, database software programs often include features that help with data protection.

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&hin' Ahead (ui): Data #etention

&rue or ,alse: &he 9$D""$ re:uires researchers who receive their funding to retain raw data for at least 1 !ears. == True == -alse

Answer: True. The 6D++6 re/uires that research data be retained for a period of B years after the pro1ect ends. Other funding agencies have different re/uirements regarding data retention. Read on to learn more.

Data #etention
"ow Long $hould Data 6e ept+ There is no set amount of time for which data should be stored. In some cases, the time period is at the discretion of the *IsA however, many sponsor institutions re/uire that data be retained for a minimum number of years after the last e3penditure report. -or instance, the 6D++6 re/uires that pro1ect data be retained for at least B years after the funding period ends. Other sponsors or funders may re/uire longer or shorter periods. Continued $torage Once the minimum storage period has been met, the *I must decide whether to continue storing the data. Although data can be kept indefinitely, a *I must evaluate the benefits and risks of e3tended storage. On the one hand, one never knows when data might be needed. On the other hand, continued storage of confidential data increases the risk of possible violation. The monetary cost of retention and security are additional concerns. Destro!ing Data .hen the decision has been made to end data storage, data should be thoroughly and completely destroyed. 'ffective data destruction ensures that information cannot be e3tracted or reconstructed. (any document storage companies now offer onsite shredding and secure destruction of written and electronic records. -or electronic data specifically, software products such as 'raser or &yber6crub are available. 6ponsor institutions and funding agencies often have their own re/uirements for how long data should be retained. ltimately, the *I must decide when it is time to end data storage.

Hearn more about data retention guidelines for the following$ @I+ grants 7http$%%grants.nih.gov%grants%p olicy%nihgps%part=ii=I.htm8 A comparison of -DA, 'nvironmental *rotection Agency "'*A#, and Organi!ation for 'conomic &o9 operation and Development "O'&D# record and reporting re/uirements 7http$%%www.fda.gov%ora%compl iance=ref%bimo%comparison =chart%record=report.html8

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Data Anal!sis
Data analysis is the way raw data is chosen, evaluated, and e3pressed as meaningful content. -or many researchers, it would be time consuming and undesirable to use all of the data collected over the course of a study. If it is to be translated into meaningful information, data must be managed and analy!ed in an appropriate fashion. Methods of Data Anal!sis There is no single method for analy!ing data. Rather, the form of analysis should come from a particular pro1ect5s functions and needs. Additional considerations might include the research setting "e.g., controlled laboratory vs. field site# or the type of research "e.g., /ualitative or /uantitative#. .ith few e3ceptions, guidelines and ob1ectives for data analysis should be determined before a pro1ect begins. &eam Members2 #esponsibilit! Data analysis is often delegated to a biostatistical services department "in the case of a large institutional research# or to a pro1ect5s statistician. If an outside statistical service is hired to do the analysis, the *I should work with the agency to ensure that the agency understands and complies with that pro1ect5s data management protocol. .hile some members of the research team will be minimally involved with data analysis, they should all understand the data analysis plan and be able to interpret the results within the conte3t of the study. 6ee ne3t page to read more about data analysis considerations. The form of data analysis must be appropriate for the pro1ect5s particular needs. 'very member of a research team should be familiar with the data analysis methods used in a pro1ect.

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%op up %age: Data Anal!sis Considerations

Eiven the important role of data analysis in a research study, it is important to avoid potential pitfalls that can invalidate or lessen the integrity of the study5s data. The following are important caveats when considering the methods of analysis and the data represented$ Methods for anal!sis

.hen planning data analyses, researchers should be aware of and work within the accepted standards for their particular area of study. 6uch standards include the form of data "e.g., census figures, ethnographic entries, or sub1ect interviews# and assumptions about the populations from which the data are e3tracted "e.g., normally distributed or independent#. If a pro1ect deviates from the accepted standards, the research team should provide 1ustification for this deviation. 6ignificance does not imply causation or establish clinical significance or practical importance. One should be aware of the abilities as well as the limitations of a chosen method of analysis. -or e3ample, the use of subgroup analysis within a given body of data may uncover significance, both in unrecogni!ed patterns as well as in false positives and improper correlationsA further research could confirm the value of such findings. 'ven with an appropriate method for evaluating data, research can often run into problems over what data to include in an analysis. &ommon problems relating to data usage include the following$ whether to include or e3clude outliers what to do when data are missing or incomplete when to appropriately alter or amend collected data how to display or organi!e data in a meaningful way Responsible data analysis attempts to accurately represent what occurred as part of the study but does not overstate the data5s importance. Data analysis becomes data manipulation when finding what you want takes precedence over representing what is in the data. ?Intentional falsification or fabrication of data or results? includes the following$

9sage of data

forging$ inventing some or all of the reported research data or reporting e3periments never performed cooking$ retaining only those results that fit the hypothesis trimming$ the unreasonable smoothing of irregularities to make the data look more accurate and precise "Adapted from the guidelines for integrity in research by (ontana Tech at The niversity of (ontana#

There are, however, instances when the amending or e3cluding of data is appropriate within data management$

after instrument problems or malfunctions after loss of or change in sub1ects or specimens after any interruptions or deviations in procedure

18

Case Vignette: Data $haring

After completing the first phase of data analysis, C of the B main hypotheses of Dr. 6mith and the research team was proven correct. +owever, the team also found some results from another facet of the pro1ect that they were not e3pecting. .hile these secondary results do not directly impact Dr. 6mith5s primary research /uestions, they may affect at least B other investigators5 research. The results appear to be pretty definitive, but data analysis is still being conducted on other parts of the pro1ect. The : Research Associates working on the pro1ect, 6amantha and 'nri/ue, are insistent that the team should immediately publish their findings in a 1ournal, since the results may have implications on other *Is5 work. Dr. 6mith and )etsy, the Research Director, do not intend to publish any results for at least another year, since the research is ongoing and some /uestions are still unanswered. *hat should the research team do+ == They should publish the results in a 1ournal as soon as possible. == They should tell the funding agency about the findings, and let the agency disseminate the information if it wants. == They should contact the other researchers to let them know the preliminary results. == They should do nothingA they aren5t legally allowed to share their results until all data have been fully validated. Answer: They should contact the other researchers to let them know the preliminary results . If Dr. 6mith believes that the results would have implications on other researchers5 work and he does not intend to publish for /uite some time, he could send his fellow researchers some information about the preliminary results as a professional courtesy and to promote collegiality. +owever, according to the guidelines of responsible data management, the researchers are not obligated to share their findings while the research is ongoing. Read on to learn more about data sharing and reporting.

19

Data $haring and #eporting

As part of the scientific process, data are e3pected to be shared and reported. This serves several purposes, including the following$ Acknowledging a study5s implications &ontributing to a field of study 6timulating new ideas )y sharing research results, a pro1ect may advance new techni/ues and theories and benefit other research. It encourages collaboration between researchers in the same field or across disciplines. Additionally, reporting of clinical research data can have a direct impact on the /uality of health care provided to patients. Data sharing usually occurs once a study has been completed. Data reporting includes discussion of the data, the data analysis, and the authorship of a pro1ect, especially in the conte3t of a particular scientific field. Data sharing and reporting are typically accomplished by publishing results in a scientific 1ournal or establishing a patent on a product. $haring Data %rior to %ublication )efore publication, there is often no obligation to share any preliminary data that have been collected. In fact, sharing at this stage is sometimes discouraged because of the following reasons$

Data sharing is the way in which research is accurately represented to the scientific community and the general public. 6haring information while the pro1ect is still in progress should be done cautiously, since the implications of the data may not be fully known. 6ome sponsor institutions and funding agencies have their own re/uirements for when and how much of a research pro1ect should be shared.

The implications for a set of data may not be understood while a pro1ect is still in progress. )y waiting until a pro1ect is ready for publication, researchers ensure that what they share has been carefully reviewed and considered. There is fear that less scrupulous researchers will use shared research results for their own gain. This apprehension causes some researchers to refrain from disseminating their findings "+elly et al., :;;:#.

The :;;B @I+ policy on data sharing states the following$ ?.e believe that data sharing is essential for e3pedited translation of research results into knowledge, products, and procedures to improve human health. The @I+ endorses the sharing of final research data to serve these and other important scientific goals. The @I+ e3pects and supports the timely release and sharing of final research data from @I+9supported studies for use by other researchers.? Read the full te3t " RH below#. 7http$%%grants.nih.gov%grants %guide%notice9files%@OT9OD9 ;B9;B:.html8

+owever, in some cases preliminary data should be shared immediately with the public and%or other researchers since it would be of immediate benefit "e.g., if a research pro1ect found that a new drug placed sub1ects at grave risk or greater benefit# "6teneck, :;;<#. In addition, many researchers find it worthwhile to present preliminary findings in a conference setting before the study is complete to inform peers about their forthcoming research. $haring Data After %ublication After a pro1ect5s research has been published or patented, any information related to the pro1ect should be considered open data. Other researchers may re/uest raw data or miscellaneous information related to the pro1ect in order to verify the published data or to further their own research pro1ect. +owever, each pro1ect should evaluate its ability to share raw data in terms of specific needs and budget constraints. Obligation to #eport *Is should be aware of the various guidelines and restrictions that may apply to the dissemination of their research. There are usually stipulations, specific to the funding agency or sponsor institution, describing when and how results should be shared. -or instance, 6)IR research may be sub1ect to certain data reporting re/uirements, depending upon pro1ect phase. In addition, government9 sponsored research or research related to biological agents may be sub1ect to federal legislation such as the *atriot Act or the -reedom of Information Act.

20

Overview: #esearch &eam #esponsibilities

Responsible data management is important in all phases of a pro1ect, from planning and data collection to data analysis and dissemination. &onse/uently, each research team member should know what role he or she plays in data management and his or her specific responsibilities. )y clearly defining what is e3pected of each member and to whom each person reports, a *I can structure a pro1ect for success. 'ach member of the research team has a different role and responsibilitiesA these should be well defined and understood by everyone.

&hin' Ahead (ui): #esearch &eam #esponsibilities

&he %I is ultimatel! responsible for all aspects of a research project/ including the oversight of data management. *hich of the following tas's is usuall! 8O& one of the %I2s da!7to7da! responsibilities+

== 6electing and training /ualified research team members == .riting proposals and grant re/uests for a pro1ect == &ollecting human sub1ects data on sensitive and confidential topics == 6erving as a liaison to the sponsor institution == All of the above tasks are the *I5s responsibility Answer: &ollecting human sub1ects data and sensitive and confidential topics. &ollecting human sub1ects data 99 even on sensitive topics 99 is not usually one of the day9to9day tasks of the *I. Rather, this is usually the responsibility of a Research Assistant or sometimes a Research Associate, although there are e3ceptions "such as in some clinical trials, for instance#. Of course, the *I is ultimately responsible for the accuracy of data collection and should be aware of the data collection protocol and progress. Read on to learn more.

21

#esearch &eam Members

Although titles, roles, and responsibilities vary by organi!ation or institution, most research teams are made up of at least > key members$ -. %rincipal Investigator The *rincipal Investigator "*I# is the individual who ultimately responsible for a pro1ect and its research. The *I enables other team members to conduct research, and is the final authority on all scientific and medical issues related to the pro1ect. )y obtaining funding and seeing that a pro1ect has the right team members, proper resources, and guidance, a *I ensures the success of the pro1ect. A pro1ect may have more than one *I, and they are &o9*rincipal Investigators. 0. #esearch Director ;%roject Director< The Research Director controls the pro1ect. )y directing the protocol for how the research and data collection are carried out, the Research Director often knows more about the day9to9day operations of the pro1ect than the *I. The Research Director works closely with the *I to both report on and redirect research. 1. #esearch Associate ;%roject Coordinator< nder the guidance of the Research Director and the *I, the Research Associate coordinates the pro1ect. This individual carries out the research itself, collecting data and assessing the effectiveness of pro1ect protocol, suggesting changes to the methodology as needed. =. #esearch Assistant A Research Assistant, although normally the least e3perienced member of a research team, carries out the pro1ect work. A Research Assistant performs the day9to9day tasks of a pro1ect, including collecting and processing the data and maintaining e/uipment. >. $tatistician The 6tatistician anal!)es the data that are collected during the pro1ect. In some pro1ects, the statistician may simply analy!e and report on the data "under the guidance of another team member# after data collection has been completed. In other pro1ects, a statistician is involved in the construction and analysis of research throughout the entire course of a study. Other &eam Members Additional team members may be involved in research studies, including clinical research specialists, laboratory technicians, interns or student researchers, grant administrators, and others. Their roles should be defined by the *I at the outset of the pro1ect. (ost research teams include at least > people$ C. the *I, who enables the pro1ect :. the Research Director, who controls the pro1ect B. the Research Associate, who coordinates the pro1ect <. the Research Assistant, who carries out the pro1ect work >. the 6tatistician, who analy!es the pro1ect data

22

Case Vignette: #esearch &eam #esponsibilities

After collecting data for about a year, Dr. 6mith5s research team revisited their original research /uestions. They decided to investigate an additional hypothesis related to a new issue that arose during the study. This change re/uired adding about a do!en new /uestions to the self9administered /uestionnaire. One day, the Research Assistant, ,oel, reali!ed that they had been administering the revised survey to sub1ects, but the Institutional Review )oard "IR)# had not yet approved the changes. *hose responsibilit! was it to ma'e sure that data collection did not continue until the I#6 approved the changes+ == The *I, Dr. 6mith == The Research Director, )etsy == The Research Associates, 6amantha and 'nri/ue == The Research Assistant, ,oel Answer: The Research Director, )etsy. The best answer is the Research Director, )etsy. It5s true that Dr. 6mith is ultimately responsible for all aspects of the pro1ect "including legal issues, as well#. +owever, in many organi!ations the Research Director is responsible for day9to9day activities like ensuring that data collection does not begin or proceed unless all IR) approvals are current. Read on to learn more about specific responsibilities of research team members.

23

&he #esearch &eam2s 3eneral #esponsibilities

It is important to note that the research team members5 positions may be fle3ible 99 one person might serve in several positions or one role might involve the efforts of several individuals. Additionally, keep in mind that many organi!ations and%or research teams have limited funding, so team members may have to fill more than one role. The table below provides further e3amples of each member5s role and responsibilities, how these positions differ, and where there is overlap in team members5 roles. Team Member

Primary Responsibilities Writes grant requests and proposals for a project Initiates a researc project and aids in t e design and i!ple!entation of protocols "elects t e researc tea! !e!#ers $ro%ides tea! !e!#ers &it t e necessar' tec nical and equip!ent training (reates a structured and effecti%e &or) en%iron!ent Writes and pu#lis es researc articles to disse!inate project findings

Accountable To *unding agenc' "ponsor institutions $rofessional associations +!plo'er and,or contractor -egal and acade!ic regulations $rincipal In%estigator

.esigns guidelines for project !et odolog'0 including data collection procedures Wor)s &it $I to redefine and redirect protocol as needed 1anages tea! !e!#ers2 ti!e and project #udgetar' issues +%aluates and docu!ents project progress and co!pliance &it protocols +nsures t at a project co!plies &it federal and Institutional 3e%ie& 4oard guidelines 5ssists &it &riting researc articles to disse!inate findings *ollo&s and i!ple!ents researc guidelines (oordinates and conducts e6peri!ents and data collection $ro%ides #asic anal'sis for data 1onitors e6peri!ents and t eir co!pliance &it t e protocols 5ids in reporting project researc $erfor!s e6peri!ents and collects data 1aintains researc supplies and,or equip!ent

(a)a $roject .irector/

$rincipal In%estigator 3esearc .irector "tatistician (at ti!es/ $rincipal In%estigator 3esearc .irector 3esearc 5ssociate "tatistician (at ti!es/

(a)a $roject (oordinator/

$erfor!s general #ac)ground and clerical &or) (e7g70 literature re%ie&0 transcription0 etc7/

+nsures project design &ill produce relia#le and %alid data +nsures researc &ill create significant data (e7g70 %ia sa!ple si8e or anal'sis !et ods/ 1onitors data collection and anal'sis 5nal'8es and prepares data for reporting

$rincipal In%estigator 3esearc .irector

24

#esearch &eam #esponsibilities: Data Management

#esponsibilities of the %I and #esearch Director (ost of the specific tasks of data management fall to the *I and Research Director. -or instance, these individuals are usually responsible for the following$ C. 'nsuring that every person who is involved in the pro1ect knows his or her rights regarding data ownership :. 'nsuring that the protocol is meticulously planned and that staff is thoroughly trained to maintain the integrity of the data collected B. Determining how to best store, protect, analy!e, and disseminate the data <. Developing a plan for addressing research misconduct and data mismanagement #esponsibilities of the Other &eam Members The primary data management responsibilities of the Research Associates and Research Assistants are usually in data collection$ ensuring the reliable and valid collection of the data and protecting the data that they have collected. 6tatisticians are primarily responsible for ensuring comprehensive and accurate data analysis. All research team members are responsible for letting the *I or Research Director know if they suspect data fraud, manipulation, or other misconduct. The *I and Research Director are usually responsible for most of the tasks related to data management. Research Associates and Research Assistants are primarily responsible for data collection, while 6tatisticians are responsible for analysis.

se our worksheet to outline each team member5s responsibilities before the pro1ect begins. This worksheet is included at the end of the document.

25

Communication Among #esearch &eam Members

Communication 6etween the %I and the &eam It is not enough for a *I to lay the groundwork for a pro1ect and then e3pect everything to run smoothly without any further assessment or input. After clearly defining team roles and responsibilities, a communications plan should be developed and implemented "establishing a communications plan will be discussed in the pages ahead.# -oremost, the *I should be able to communicate well with his or her team. If possible the *I should personally educate the team members about research integrity issues, involve team members in a discussion of how data will be managed, and promote open communication amongst team members about problems or concerns. 6econdly, feedback to the team is necessary. A *I5s feedback keeps the team members informed about a pro1ect5s developments and any changes that may directly affect individuals5 roles or responsibilities. -eedback from the *I may also provide positive reinforcement. .eekly or monthly status meetings that the *I organi!es and attends may help encourage feedback and open communication. Communication Among &eam Members 6imilarly, team members must communicate with each other and the *I as the pro1ect progresses or when problems arise. 'ffective communication involves fre/uent and open dialogue among all team members, enabling research to proceed smoothly. A clear communications plan will ensure that everyone has an accurate picture of what is happening now and what needs to happen in the future. 'stablishing a clear and effective communications plan will ensure that all research team members are aware of the pro1ect5s status, time line, changes, and any problems encountered.

26

&hin' Ahead (ui): Communication and Leadership

A strong leader with good communications s'ills is able to guide both the project and the project members. *hich statement is true about the role of the %I as the leader of the research team+

== 6ince he or she is rarely involved in data collection or analysis, the *I defers authority to the Research Director and 6tatistician. == The *I deals with human resource issues such as benefits and paid time off. == The *I provides a clear, unifying vision of the pro1ect ob1ectives, protocols, and progress to the research team. == The *I has minimal contact with the research teamA thus, leadership is not an issue. == @one of the above statements are true. Answer: The *I provides a clear, unifying vision of the pro1ect ob1ectives, protocols, and progress to the research team. The *I does serve as leader of the research team, and it is his or her role to communicate the pro1ect5s vision to the research team members and to clarify each member5s role and responsibilities. Read on to learn more.

27

&he #ole of Leadership in Communication

In order for a research team to function and communicate effectively, the *I must be able to lead the pro1ect and the pro1ect5s members. A *I who is an effective leader conducts himself or herself as follows$ *rovides a clear vision for the pro1ect Defines common goals for team members Acts as a authority figure in the team yet is approachable -osters sharing of responsibilities *romotes teamwork by sharing information *rovides positive feedback and constructive criticism Defining Common 3oals The *I must be able to provide clear pro1ect goals from the outset. +owever, simply providing goals does not constitute effective leadership. The *I must also unify the team by involving each team member in the vision and goals for the pro1ect. This means that the *I should make each team member aware of common goals and how that member5s own role and responsibilities fit into the larger pro1ect. Defining common goals fosters motivation and accountability and promotes collaboration and communication 99 individuals will know which members are responsible for what parts of a pro1ect as well as to whom each person can turn for guidance. An Authorit! ,igure As the head of a pro1ect, the *I also serves as the authority figure, setting a standard for accountability and approachability that team members will rely on and replicate. Team members should feel that they can trust and approach the *I with any issues that may arise. The *I should be aware that his or her actions and decisions can affect every aspect of the pro1ect. Managing Conflict Eiven that differences are inevitable, a *I must also be able to manage conflicts among team members "discussed further on the ne3t page#. The *I should lead both the pro1ect and the research team by defining goals, encouraging communication and teamwork, and managing conflict. As the head of a pro1ect, the *I also serves as the authority figure and sets the standard for accountability and approachability.

28

%op up %age: Managing Conflicts Among the #esearch &eam

Over the course of a pro1ect, it is inevitable that conflict will arise among team members. As the team5s leader, the *I should be able to recogni!e and deal with conflict before it becomes a threat to pro1ect stability. 6ome potential problem areas that the *I should be aware of include the following$ &lashing personalities between team members -rustration with the pro1ect or work stress Dissatisfaction with or refusal to follow research protocols Improper management of resources nbalanced division of labor Hack of recognition or credit within a pro1ect Regardless of the conflict5s cause, its resolution must take place in an environment where team members feel they can honestly approach the *I "or another member# and e3press themselves. The best way to do this is by providing constructive feedback in a private setting. &onstructive feedback includes the following actions$

Listening to the other individual. The *I should refrain from correcting, reacting to, or otherwise interrupting the other person while he or she is speaking. The *I should engage in active listening, which involves demonstrating through body posture, facial e3pression, and attentiveness that one is aware of and interested in what the other person is trying to convey. This demonstrates respect for the other person and his or her opinions. 5?pressing a position in a non aggressive and non1udgmental manner. The *I should e3plain and clarify the reasons behind his or her position and place these reasons in the conte3t of the larger vision for the pro1ect or team. '3pressing one5s self in this way emphasi!es honesty, approachability, and trust in resolving issues. Refrain from using technical 1argon or e3pressing opinions as fact. Discussing the problem in terms of the larger picture. The *I should not criti/ue the person but rather the idea. This means trying to understand why a particular idea is creating a conflict and uncovering any issues that could reconcile the conflict. It may be helpful to recogni!e and compliment the other person on some aspect of his or her idea. Doing so shows respect for the other person5s opinions and demonstrates that the *I is trying to understand the logic behind it. )y focusing on the conflict itself and the thought process behind it, a *I can prevent discussion from disintegrating into an argument and thus may resolve the conflict more effectively.

29

Case Vignette: Communication

A few weeks after Dr. 6mith added the new /uestions to the self9administered /uestionnaire, it occurred to the Research Assistant, +eather, that the data collection methodology could be changed slightly. 6he reali!ed that the first /uestionnaire that was administered to sub1ects "a survey on attitudes# now included information that provided answers to the /uestions on a subse/uent /uestionnaire "a knowledge pre9test#. +eather reali!ed that it would make much more sense to administer the knowledge test before the attitude /uestionnaire. "ow should "eather proceed+ == +eather should make the change with her sub1ects and start administering the knowledge test before the attitude /uestionnaire. == +eather should tell her fellow Research Assistants about the change so that they can all follow the same methodology. == )efore proceeding, +eather should ask Dr. 6mith for permission to make the change. Dr. 6mith may have a particular reason for wanting to ask the attitude /uestions first. == +eather shouldn5t do anything until she refers to the communication plan to determine Dr. 6mith5s system for revising the methodology. Answer: +eather shouldn5t do anything until she refers to the communication plan to determine Dr. 6mith5s system for revising the methodology. The research team should have a communications plan in place, and +eather should refer to this plan before she proceeds. &hanges in methodology during the course of a research pro1ect are not uncommon, and it is likely that the *I has a system in place for discussing and revising the data collection procedures as needed. -or instance, it may re/uire a meeting or an e9mail or memo to affect such a change. Read on to learn more about establishing a communications system within the research team.

30

5stablishing an 5ffective Communications %lan

The *I should develop and implement a communications plan at the pro1ect5s outset. .henever possible, the communications plan should be written down and distributed to all members of the research team. At any point in the pro1ect, team members should know what information is communicated, to whom, and how. &he ,irst $teps in a Communications %lan The first step in a communications plan is to establish the chain of command and determine who can make decisions about different aspects of the pro1ect. )asic ground rules also should be outlined, such as whether or not the team should keep written or electronic records of important communications. A good communications system will serve as a check9and9balance system and maintain the integrity of the research pro1ect. )est practice tipe for communication are discussed further on the ne3t page. &he 8e?t $teps The communication plan should also address data collection issues. A system for monitoring and checking data collection should be defined well before data collection begins. 6uch a system should document each step in the data collection process and whose responsibility it is. The following /uestions should be addressed$

The *I should establish and implement a communications plan at the start of the pro1ectA all research team members should receive a written copy of the plan. Data management activities and progress should be included in the communications plan.

+ow much data have been collected and by whomF +ave the data been entered or transferred into an electronic formatF +ave the transferred data been double9checked against the original "by a different team member# to ensure accuracyF -or human sub1ects data, have identifiers been stripped from each and every recordF

&ommunication can be conceptuali!ed as more than 1ust written and verbal. The *I should also consider the role of the following$ Internal "within the research team# and e3ternal "other pro1ect stakeholders# communications

-ormal "reports, grant proposals# and informal "memos, e9 mails# communications Lertical "within the research team# and hori!ontal "between peers# communications "*ro1ect (anagement Institute, :;;;#

Other Data Management Issues to Consider The communications plan should consider other data management activities as well. -or e3ample, while the *I and Research Director don5t need to be informed every time a Research Assistant collects new data, the communications plan should outline how the Research Assistant updates the team. In this instance, the Research Assistant could provide a weekly e9mail to the team with a summary of data collection activities, or he or she could log daily activity in a notebook. Another e3ample of a communications issue to be considered is how a team member might convey the results of a monthly virus scan on the entire network. The plan might re/uire the Research Associate to keep a logbook, with dated entries for each scan that is run without incident. The communications plan should be also deal with a scan that finds a potentially harmful computer virus.

31

%op up %age: 6est %ractice &ips: Communication

'stablishing a communications plan will help the pro1ect run more smoothly. .hen starting a new pro1ect, consider these best practice tips on research team communication$ &reate a flowchart that lists all members of the research team, their responsibilities, who they are accountable to, who they supervise, etc. Include this in the communication plan or post it in a common area.

Develop a plan for reporting pro1ect progress, proposed changes, and problems. An e9mail or memo may suffice for some issues, while other issues may re/uire a team meeting. +old team meetings on a regular basis as well as one9on9one meetings with individual team members. These conversations provide an opportunity for members to provide feedback or bring up problems that they might not feel comfortable discussing in front of the whole team. &reate a team calendar that contains important dates for your pro1ect, such as team meetings or deadlines for progress reports. In addition, choose a way to notify team members, perhaps via e9mail or memorandum, when important dates are approaching. &learly outline rights to data ownership, intellectual property, and publication when a pro1ect is collaborative or involves the efforts of several *Is and%or Research Directors. 6pecify how and when research data can be published so as to avoid confusion later on. 'ven if not re/uired, consider establishing a structured system for communicating with the sponsor institution and the funding agency. This may entail making periodic phone calls or sending monthly progress reports to keep them informed about the status of the pro1ect.

32

Conclusion
Data management is a critical component of most scientific research studies. The *I should consider the following issues when establishing a data management system for a new research pro1ect. Addressing each of these issues at a pro1ect5s inception will allow the *I to run an organi!ed research pro1ect. Issue to Be Addressed Data Management Needs and Preferences Action to Take 5fter outlining t e project needs regarding data collection0 storage0 protection0 retention0 etc70 t e $I s ould assign tas)s related to eac of t ese needs to t e appropriate tea! !e!#er7 9 e $I s ould #e fa!iliar &it eac tea! !e!#er2s s)ills so t at appropriate tas)s can #e assigned and,or training can #e arranged & en needed7 9 e $I s ould clearl' define eac tea! !e!#er2s responsi#ilities for eac aspect of t e project so t at t e data2s integrit' is !aintained at all ti!es7 5t t e start of t e project0 t e $I s ould re%ie& ot er data !anage!ent issues :: suc as t ose related to data o&ners ip and s aring :: to deter!ine if t e' pose a concern7 5fter esta#lis ing an action plan for co!pleting t e project0 t e $I s ould &rite a detailed ti!e line0 to )eep t e entire tea! infor!ed of i!portant dates and deadlines7 The *I should consider the pro1ect5s data management needs, the research team members5 skills and e3perience, the pro1ect5s time line, and potential problems and solutions when starting a new pro1ect.

Research Team Members' kills and !"perience

Research Team Members' Roles and Responsibilities Potential Problems and olutions

se our worksheet to outline each team member5s skills and responsibilities at the start of a new pro1ect. The worksheet is included at the end of the document.

Pro#ect Time $ine

33

#eview of e! %oints
6asics Concepts in Data Management Data management includes several key concepts. It is important to understand what these terms mean as well as how they relate to the responsible conduct of research.

Data are any information or observations that are associated with a particular pro1ect, including e3perimental specimens, technologies, and products related to the in/uiry. Data ownership refers to the control and rights over the data as well as data management and use. Data ownership is a comple3 issue involving the *I, the sponsoring institution, the funding agency, and any participating human sub1ects. Data collection provides the information necessary to develop and to 1ustify research. A successful pro1ect collects reliable and valid data. Data collection is reliable when it is employed in a consistent and comprehensive manner throughout the course of a pro1ect. Diligent record keeping 99 whether written or electronic 99 is essential to ensure the validity of data. 6toring data safeguards a research investment. 6torage allows future access to the data in order to re9create the findings, augment subse/uent research, or establish a precedent. 'nough data should be stored so that a pro1ect and its findings can be reconstructed with ease. The best way to protect data is to limit access to it, whether the data are in written or electronic form. 'lectronic data storage re/uires additional safeguards. 6ponsor institutions and funding agencies often have their own re/uirements for data retentionA ultimately, the *I must decide when it is time to end data storage. Data analysis of a pro1ect must be appropriate for the pro1ect5s particular needs. Data sharing while a pro1ect is still in progress is often discouraged, since the implications of the data may not be fully known. 6ome sponsor institutions and funding agencies have their own re/uirements for when and how much of a research pro1ect should be shared.

#esearch &eam #esponsibilities 'ach member of the research team has a different role and responsibilitiesA these should be well defined and understood by everyone.

(ost research teams include at least > people$ the *I, who enables the pro1ectA the Research Director, who controls the pro1ectA the Research Associate, who coordinates the pro1ectA the Research Assistant, who carries out the pro1ect workA and the 6tatistician, who analy!es the pro1ect data. The *I and Research Director are usually responsible for most of the tasks related to data management. Research Associates and Research Assistants are primarily responsible for data collection, while 6tatisticians are responsible for analysis.

5stablishing a Communications %lan 'stablishing a clear and effective communications plan will ensure that all research team members are aware of the pro1ect5s status, time line, changes, and any problems encountered.

The *I should lead both the pro1ect and the research team by defining goals, encouraging communication and teamwork, and managing conflict. As the head of a pro1ect, the *I also serves as the authority figure and sets the standard for accountability and approachability. The *I should establish and implement a communications plan at the start of the pro1ectA all research team members should receive a written copy of the plan, which should also address data management activities.

34

,inal $tep
Thank you for viewing our data management courseM The following references and useful resources are included below$ &ourse References #esources

Data (anagement N Eeneral Data Ownership and Retention Data &ollection and Record Keeping Data 6torage and *rotection Data 6haring and *ublication +uman 6ub1ects Research Animal Research Research Team Headership and &ommunication

35

#eferences
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(ontana Tech at The niversity of (ontana. A policy to assure the integrity of research and scholarly activity. -ebruary C<, :;;;. Available at$ http$%%www.mtech.edu%research%proposalprep%(TG:;ResearchG:;IntegrityG :;*olicyG:;atG:;B9:9;;.pdf. Accessed August C>, :;;>. (ullner R, &hung K. The American +ospital Association5s annual survey of hospitals$ a critical appraisal.,ournal of &onsumer (arketing. :;;:AC4"J#$IC<9ICD. @ational Institutes of +ealth. &linical research training course. Available at$ http$%%www.cc.nih.gov%researchers%training%crt.shtml. Accessed August D, :;;>. @ational Institutes of +ealth. &ontracts vs. grants$ what5s the differenceF Available at$ http$%%grants.nih.gov%grants%funding%contracts=vs=grants.htm. Accessed August D, :;;>. @ational Institutes of +ealth. +uman sub1ects research and IR)s 99 bioethics resources on the .eb. -ebruary C, :;;>. Available at$ http$%%www.nih.gov%sigs%bioethics%IR).html. Accessed 6eptember C;, :;;>. @ational Institutes of +ealth. @I+ data sharing policy and implementation guidance. (arch >, :;;B. Available at$ http$%%grants.nih.gov%grants%policy%data=sharing%data=sharing=guidance.htm. Accessed August D, :;;>. @ational 6cience -oundation. Directorate for 'ngineering$ D(II reporting information for 6)IR. Available at$ http$%%www.nsf.gov%eng%sbir%reporting:.1sp. Accessed August D, :;;>. *ennsylvania 6tate niversity. )uilding blocks for teams. ,une :<, :;;>. Available at$ http$%%tlt.its.psu.edu%suggestions%teams%student%inde3.html. Accessed on 6eptember I, :;;>. *ons A*, Al1ifri +. Data protection using watermarking in e9business. ,ournal of Database (anagement. :;;BAC<"<#$ C9CB. *ro1ect (anagement Institute. A Euide to the *ro1ect (anagement )ody of Knowledge. @ewtown 6/uare, *enn$ *ro1ect (anagement InstituteA :;;;. Rhodes H,. Institutional environments and responsible conduct of research "R&R# 7 niversity of @evada 9 Has Legas .eb site8. Available at$ http$%%www.unlv.edu%Research%icoi%*resentationG:;>G:;9InstitutionalG:;'nvironmentsG :; PG:;R&RG:;9G:;HasG:;LegasG:;9G:;C:9;<G:;9G:;HG:;Rhoades.pdf. Accessed August C, :;;>. 6igma Ri The 6cientific Research 6ociety. :;;; forum proceedings$ oversight of research staff by principal investigator. Available at$ http$%%www.sigma3i.org%meetings%archive%forum.:;;;.oversight.shtml. Accessed August C, :;;>. 6ociety for &linical Data (anagement. Eood clinical data management practices, version B. :;;B. Available at$ http$%%www.scdm.org%gcdmp%gcdmp=vB=e;<B>;d;B;gC:CCC.pdf. Accessed on August D, :;;>. 6teneck @+. Introduction to the responsible conduct of research 7Office of Research Integrity .eb page8. :;;<. Available at$ http$%%ori.dhhs.gov%documents%rcrintro.pdf. Accessed August C, :;;>. 6traub ,. The digital tsunami$ a perspective on data storage. Information (anagement ,ournal. :;;<ABD"C#$<:9>;. Tonkens R. &linical research organi!ations offer wide range of management opportunities for physician e3ecutives. *hysician '3ecutive. :;;>ABC"C#$BD9<;. niversity of Alaska 9 -airbanks, Office of Research Integrity. Research policies. Available at$ http$%%www.uaf.edu%ori%res=policies.htm. Accessed August C, :;;>. niversity of &alifornia 9 )erkeley, Office of +uman Resources. Euide to managing human resources$ a resource for managers and supervisors at )erkeley. Available at$ http$%%hrweb.berkeley.edu%guide%contents.htm. Accessed on 6eptember I, :;;>. niversity of &alifornia 9 6an -rancisco, Office of Research. @ew investigators$ a /uick guide to starting your research at &6-. Available at$ http$%%www.research.ucsf.edu%QE%orQgDm.aspS*oints. Accessed August C, :;;>. niversity of -lorida, &ollege of (edicine. E(6 I4BC$ responsible conduct of biomedical research. Available at$ http$%%idp.med.ufl.edu%rcr%. Accessed on August D, :;;>.

37

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niversity of Houisville. Research integrity program$ guidance for development of a management plan. Available at$ http$%%www.ori.louisville.edu%6-I%(anagement=*lans%(anagement.htm. Accessed on August C, :;;>. niversity of @ew +ampshire. *olicy on ownership and management of research data. Available at$ http$%%www.unh.edu%orps%downloads%DataOwnershipand(anagement.pdf. Accessed August D, :;;>. niversity of @orth &arolina 9 &hapel +ill. Office of +uman Research 'thics page. Available at$ http$%%research.unc.edu%ohre%. Accessed August D, :;;>. niversity of *ittsburgh. Euidelines on data retention and access. Available at$ http$%%www.pitt.edu%Tprovost%retention.html. Accessed August D, :;;>. niversity of *ittsburgh. Office of Research Integrity Euidelines for 'thical *ractices in Research page. Available at$ http$%%www.pitt.edu%Tprovost%ethresearch.html. Accessed on August D, :;;>. niversity of Te3as 9 )rownsville, Te3as 6outhmost &ollege, &orporate &ompliance Office. &ompliance corner. April CB, :;;>. Available at$ http$%%www.nih.gov%sigs%bioethics%IR).html. Accessed 6eptember C;, :;;>. 6 Dept of +ealth and +uman 6ervices. Data management in biomedical research$ report of a workshop. *resented at$ .orkshop on Data (anagement in )iomedical ResearchA April :>, C44;A &hevy &hase, (d. 6 Dept of +ealth and +uman 6ervices. Euidelines for the conduct of research within the *ublic +ealth 6ervice 7'ast Tennessee 6tate niversity .eb site8. C44:. Available at$ http$%%www.etsu.edu%research=ethics%ori.guidelines.pdf. Accessed August C, :;;>. 6 Dept of +ealth and +uman 6ervices. O+R* code of federal regulations$ protection of human sub1ects. Available at$ http$%%www.hhs.gov%ohrp%humansub1ects%guidance%<>cfr<I.htm. Accessed 6eptember C;, :;;>. 6 -ood and Drug Administration. &omparison chart of -DA and '*A$ records and reports. Available at$ http$%%www.fda.gov%ora%compliance=ref%bimo%comparison=chart%record=report.html. Accessed 6eptember C;, :;;>. 6 Office of *ersonnel (anagement. E69::;; 9N information technology group. Available at$ http$%%http$%%www.opm.gov%fedclass%te3t%E69::;;.htm. Accessed August D, :;;>. .ake -orest niversity. *olicies and procedures$ research related policies 9N ethical standards in research. Available at$ http$%%wwwC.wfubmc.edu%OR%*oliciesUandU*rocedures%(anual%6ectionUCU9U'thicalU6tandards.htm. Accessed on August D, :;;>. .inkler A, (c&arthy *. (a3imising the value of missing data. ,ournal of Targeting, (easurement and Analysis for (arketing. :;;>ACB":#$CID9CJD.

38

Online Resources
General Data Management Northwestern University: Policies & Guidelines for Investigators in Scientific Research. http://www.northwestern.edu/research/policies/investigatorsIntegrity.ht l ! "his we#site includes an e$planation of research isconduct and research integrity as well as guidelines specifically for Northwestern staff that can #e adapted to other research settings. %ffice of Research Integrity: Introduction to the Responsi#le &onduct of Research. http://ori.dhhs.gov/docu ents/rcrintro.pdf ! "his %RI pu#lication provides a #rief overview of the ' core concepts related to responsi#le conduct of research. University of &alifornia ( San )rancisco* +epart ent of Neurological Surgery: Guidelines on Research +ata and Reports. http://neurosurgery. edschool.ucsf.edu/acade ics/guidelines.ht l ! "his online docu ent descri#es ,good research practices, for PIs* including guidelines for data anage ent* record -eeping* authorship* and data reporting. .ale University School of /edicine* %ffice of Grant & &ontract 0d inistration and Scientific 0ffairs: Guidelines for the Responsi#le &onduct of Research at .ale University School of /edicine. http://grants. ed.yale.edu/policies/guidelin.ht l ! "his resource outlines the research policies and guidelines at .ale University on topics such as research tea responsi#ilities* data anage ent* and data ownership/authorship. Data Ownership and Retention %ffice of /anage ent and 1udget. &ircular No. 0(223: Unifor 0d inistration for Grants. Section 45: Retention and access re6uire ents for records. http://www.whitehouse.gov/%/1/circulars/a223/a223.ht l745 ! "his circular fro 8$ecutive %ffice of the President descri#es the legal retention and access re6uire ents for records fro federally funded research. University of 0ri9ona: :and#oo- for Principal Investigators (( "echnical Responsi#ilities. http://www.sps.ari9ona.edu/hand#oo-/technicalresponsi#ilities.ht ! "his section fro the University of 0ri9ona;s :and#oo- for Principal Investigators descri#es re6uisite technical responsi#ilities for the position* including concerns for data ownership* retention* and changes to research protocol. University of &hicago: University Research 0d inistration (( Regulations* Policies* and Procedures. Intellectual Property* +ata Rights* and +ata Retention. http://researchad in.uchicago.edu/regulations/intellectual<prop.sht l ! "his we#site fro the University of &hicago discusses various policies on intellectual property and data rights as well as a section containing helpful lin-s on these topics. United States &opyright %ffice. http://www.loc.gov/copyright ! "his is the ho e page of the U.S. &opyright %ffice= it contains infor ation on registering and searching for copyrights. United States Patent and "rade ar- %ffice. http://www.uspto.gov ! "his is the ho epage of the U.S. Patent and "rade ar- %ffice and it contains infor ation on filing

and searching for currently registered patents. Data Collection and Record Keeping University of )lorida* %ffice of "echnology >icensing: Good Record ?eeping (( Procedures for 0cade ic >a#oratory Settings. http://rgp.ufl.edu/otl/goodrecords.ht l ! "his we#site fro the University of )lorida descri#es #oth the need for and the i ple entation of successful record -eeping in acade ic la#oratory settings. University of &alifornia ( San )rancisco* %ffice of Research: New Investigators @uic- Guide: Guidelines for >a#oratory Note#oo-s. http://www.research.ucsf.edu/@G/or@gN#.asp ! "his section fro U&S);s New Investigators @uic- Guide descri#es how to properly -eep and la#oratory note#oo-s. aintain

&o onwealth of 0ustralia* National 0rchives of 0ustralia: +igital Record-eeping Guidelines (( Guidelines for &reating* /anaging* and Preserving +igital Records. http://www.naa.gov.au/record-eeping/er/guidelines.ht l ! "his we# page fro the National 0rchives of 0ustralia provides a co prehensive set of guidelines for digital record -eeping* including issues related to creation* storage* protection* and destruction. University of /ichigan* University 0rchivists Group: 8lectronic Record-eeping Guidelines. http://www( personal.u ich.edu/Adero edi/&I&/guide.ht ! "his we# page contains lin-s to guidelines and other online resources for electronic record -eeping used #y the University 0rchivists Group at the University of /ichigan. Data Storage and Protection 8cono ic and Social +ata Service: Identifiers and 0nony isation: +ealing Bith &onfidentiality. http://www.esds.ac.u-/aandp/create/identguideline.asp ! "his we# page discusses the proper way to re ove or to restructure research identifiers in order to aintain confidentiality. University of 1ath: General +ata Protection Guidelines for Staff and Students. http://internal.#ath.ac.u-/data( protection/guidelines.ht ! "his we#site fro the University of 1ath discusses general data protection guidelines* highlighting C principles for achieving successful data protection co pliance. University of /innesota* Institutional Review 1oard: 8lectronic +ata Storage and Security. http://www.research.u n.edu/ir#/guidance/data/inde$.cf ! "his section of the University of /innesota;s Guidance for Research provides reco endations for -eeping research data secure* including tips for passwords and lin-s to data security products. Data Sharing and Publication :arvard University: +ata Sharing and Replication. http://g-ing.harvard.edu/replication.sht l ! "his we#site contains a wide range of lin-s on data sharing* including discussions and relevant policies for various Dournals and funding agencies. /ount Sinai School of /edicine: :and#oo- for Research (( Section III: Guidelines for Reporting Research Results. http://www. ss .edu/forfaculty/hand#oo-<rs/articles.sht l ! "his we#site fro /ount Sinai School of /edicine provides guidelines for su# itting articles to

scientific Dournals and discusses what constitutes appropriate content* citation* and authorship. National Institutes of :ealth: NI: +ata Sharing Policy. http://grants.nih.gov/grants/policy/data<sharing ! "his we#site contains infor ation* )0@s* wor-#oo-s* and testi onials on the su#Dect of data sharing in relation to the NI:;s data sharing policy. %nline 8thics &enter: Research 8thics /odule. Responsi#le 0uthorship. http://onlineethics.org/reseth/ od/auth.ht l ! "his odule fro the %nline 8thics &enter discusses responsi#le authorship* providing scenarios and suggested readings on the su#Dect. Human Subjects Research &enters for +isease &ontrol and Prevention* %ffice of the &hief Science %fficer: :u an Su#Dects +ocu ents. http://www.cdc.gov/od/ads/hsrdocs.ht ! "his we#site fro the &+& contains a variety of docu ents on the su#Dect of hu an su#Dects research* including guides for writing consent docu ents* responding to IR1 reports* and protecting research su#Dects. National Institutes of :ealth: :u an Su#Dects Research and IR1s. http://www.nih.gov/sigs/#ioethics/IR1.ht l ! "his resource page fro the NI: contains lin-s to infor ation on hu an su#Dects research* a ong the lin-s to policies and regulations* IR1 resources* and guidance for investigators. National Institutes of :ealth* %ffice for Protection fro Research Ris-s: 2''5 Institutional Review 1oard Guide (( Protecting :u an Research Su#Dects. http://www.geno e.gov/23332E4F ! "his 2''5 guide#oo- fro the NI: e$plains and discusses the issues involved in approving and reviewing hu an genetic research #y Institutional Review 1oards. United States +epart ent of 8nergy* %ffice of 1iological and 8nviron ental Research: Protecting :u an Su#Dects. http://www.er.doe.gov/production/o#er/hu su#D/inde$.ht l ! "his we#site fro the +epart ent of 8nergy contains resources for hu an su#Dects research* including a proDect data#ase* consent for infor ation* and details on receiving accreditation. US +epart ent of :ealth and :u an Services* %ffice of :u an Research Protections. http://www.hhs.gov/ohrp/hu ansu#Dects/guidance/G4cfrGH.ht ! "his we#site contains the &ode of )ederal Regulations* as set up #y the US+::S(%:RP for the protection of hu an su#Dects. Animal Research Institute for >a#oratory 0ni al Research. http://dels.nas.edu/ilar<n/ilarho e ! "his we#site provides science(#ased guidelines for ani al research as well as infor ation on various ani al odels and strains. National Institutes of :ealth* %ffice of >a#oratory 0ni al Belfare. http://grants.nih.gov/grants/olaw/olaw.ht ! "he %ffice of >a#oratory 0ni al Belfare we#site provides lin-s to current news flashes* policies and laws* guidance* and other resources within the real of ani al research. Rutgers University School of >aw: 0ni al Rights >aw ProDect (( )ederal 0ni al Belfare 0ct and Regulations.

http://www.ani al(law.org/welfact ! "his we#site contains infor ation on the United States code and its regulations that govern the treat ent and handling of ani als in research and nonresearch settings. United States +epart ent of 0griculture* National 0gricultural >i#rary: 0ni al Belfare Infor ation &enter. http://www.nal.usda.gov/awic/inde$.ht l ! "he 0ni al Belfare Infor ation &enter we#site provides a variety of infor ation on su#Dects fro govern ent and legal resources on la# ani als* 9oos* circuses* and wildlife. Research "ea >eadership and &o unication +art outh University* %ffice of Sponsored ProDects: Role of the Principal Investigator. http://www.dart outh.edu/Aosp/resources/ anual/post(award/pirole.ht l ! "his we#page descri#es the role of the Principal Investigator in sponsored research. Sig a Ii "he Scientific Research Society: F333 )oru Proceedings (( %versight of Research Staff #y Principal Investigator. http://www.sig a$i.org/ eetings/archive/foru .F333.oversight.sht l ! "his panel discussion atte pts to descri#e how Principal Investigators should staff* citing cases of research isconduct and case scenarios. anage their research

University of &alifornia* %ffice of :u an Resources: Guide to /anaging :u an Resources (( 0 Resource for /anagers and Supervisors at 1er-eley. http://hrwe#.#er-eley.edu/guide/contents.ht ! 1er-eley;s Guide to /anaging :u an Resources contains a wide range of infor ation on su#Dects such as recruiting staff* anaging staff successfully* and pro oting successful wor- relations.

Review of Key Concepts in Data Management

Key Concept Data Ownership How it Relates to Responsible Conduct of Research Concerns who has the legal rights to the data and who retains the data after the project is completed, including the PI's right to transfer their data between institutions Concerns collecting data in a consistent, systematic manner throughout the project (reliability) and establishing an ongoing system for evaluating and recording changes to the project protocol (validity) Concerns the amount of data that should be stored - enough so that project results can be reconstructed Concerns protecting both written and electronic data from physical damage as well as damage to data integrity, including tampering or theft Concerns how long project data needs to be retained according to various sponsors' and funders' guidelines, and the importance of secure destruction of data Concerns how raw data is chosen, evaluated, and interpreted into meaningful and significant conclusions that other researchers and the public can understand and use Concerns how project data is disseminated to other researchers and the general public to share important or useful research results; also, when data should not be shared Concerns publication of conclusive findings after the project is completed

Data Collection

Data Storage Data Protection

Data Retention

Data Analysis

Data Sharing

Data Reporting

For more information about Responsible Conduct of Research, visit the Office of Research Integritys website at http://ori.dhhs.gov

Project ___________________________________________________________________ Page#_____ DOUBLE-ENTRY Data Collection Subject ID # Date Collected Staff Initials Data Transfer #1 Date Transferred Staff Initials Data Transfer #2 Date Transferred Staff Initials PI/RD Review All Errors Fixed? Staff Initials

Project ______________________________________________ Team Member

Name:

Skills & Strengths

Assigned Tasks

Other Responsibilities

Supervised by:

Supervisor to:

Name:

Supervised by:

Supervisor to: