XACT Manual of Procedures

Chapter 17: Study Documentation

Summary of edits between version 4.0 and 5.0

Section D added new sections D2 through D9
Section D Added new point to section D1 under last bullet
Summary of edits between version 3.1 and version 4.0
Entire document Changed all subject references to participant.
Entire document Corrected forms names to their finalized names.
Section A Added new purpose Provide guidelines for correcting errors on study
documentation.
Section C (formerly C.2) Error correction process applied to all study documentation rather
than just progress notes.
Section E Provided clearer documentation of where to store the different types of documents.
Summary of edits between version 3.0 and version 3.1
Changed all references from lozenge(s) to mint(s).

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Chapter 17: Study Documentation

Appropriate study documentation is critical for conducting clinical trials. This chapter describes
principles of good practices in documentation and summarizes procedures for recording progress notes,
detailing each participants involvement in the study. It also defines the types of study documentation that
will be required and how to best assemble it and keep it secure. Specific details for how each case report
form (CRF) is collected are included in the relevant visit chapter as well as in the CRF-specific Coding
and Administration Instructions.
A. Purpose
The purpose of this chapter is to:
1. Provide guidelines for correcting errors on study documentation
2. Define the required documentation process for progress notes
3. Provide guidance on study material storage
4. Define the types of documents that will be created for the trial and how they should be organized
B. Personnel
Study Coordinator
C. Correcting Errors on Study documentation
Errors happen. Everyone makes them. The important thing is to know what to do about errors so that they
do not create questions about the integrity of the data record. Most importantly, if you make a mistake
and don't know what to do, consult with your supervisor or the DCC. Trying to guess your way through a
mistake can make it look like you are trying to cover up something. Almost all mistakes can be handled,
but it is important to deal with them directly.
If you make a mistake while writing on any study documentation (e.g. CRFs, Progress Notes, Logs),
using a red pen, put a single line through the error and write in the correct information next to the field
that contained the errant data. Continue using the red pen and enter todays date and your initials beside
the correction; write in a brief explanation for the correction (e.g., wrong item checked, participant
changed her answer).
Never cover up your mistakes by:
Scribbling over the mistake.
Using White-Out or similar product.
Re-writing over the top of the note.
Entering a date other than todays date. Never put any date other than today's date on a note (e.g.,
putting yesterday's date on a note because that is the day that the data collection occurred). This is
a form of data falsification. If you were unable to complete documentation on the date that a
research activity occurred, write a late note. Never backdate.
o Example: A late note for data collection which occurred on March 14, 2007, could be
written: Late note for 03/14/07. Participant stated that she will be out of the country for the
next 3 months. 03/20/07 KF

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D. Progress Notes
Documentation of participants' involvement and ongoing progress is critical to the success of any research
protocol. If it isnt written down, it didnt happen. Appropriate documentation ensures that any questions
that arise regarding participants participation can be answered. Timely and accurate documentation also
ensures that the data record is complete and free from errors. Additionally, thorough documentation
increases the likelihood that errors found in the data record can be resolved from existing records.
D.1 Progress note guidelines
The entire evaluation of a research protocol depends upon the data collected from the participants. Each
participant will have a progress notes area in their research chart to document everything that did or did
not occur in a study contact. Progress Notes Checklists as well as other progress notes should be filed in
this area of the chart. In order to ensure that the information is complete, accurate, and thorough, the
following guidelines should be used:
Documentation should be completed on the day that the activity occurred
Use black ink only (to assure legible photocopies or faxes)
Write enough information to document the activity or data, but don't go overboard; notes should
be brief and to the point
Do not use names in the progress notes
o Refer to participant rather than Mr. Smith
o If you need to refer to another person, refer to them by relationship rather than by name (e.g.,
participant 's sister, not Betty Smith or Betty)
Don't leave any blank spaces cross out any blank spaces or lines that are above your note on the
page to ensure that undocumented late notes cannot be added.
Initial and date at the END of each note once the note is complete, to prevent the addition of
information at a later date without proper documentation
Any protocol violations related directly to a participant should be detailed in the progress notes.
The details should include a description of the violation, the date the violation occurred and any
follow-up contact with the participant that will be required as a result of the violation.
D.2 Progress note checklists
The DCC provides participant specific progress note checklists that can be printed from the DEMS. To
access these checklists, click on the visit name link at the top of the participants calendar.
These checklists contain a lot of important information about a specific visit including the acceptable visit
window for the visit, the participant ID number, each required form and procedure that should be
completed at each visit in the preferred order of administration, each optional form that could be
completed, a space to record participant reimbursement and a space to record notes about the visit. If
sites choose, the checklists can be used as the primary progress note sheets for each visit. Using the
checklists should simplify the progress notes process by alleviating some of the recording requirement.
For example, since each form and procedure is already listed on the form, using these checklists replaces
the requirement that staff record the name of each form completed during a visit. These forms can simply
be checked off on the progress note checklist.
If sites need more space to record progress notes in addition to the space that is provided at the bottom of
each progress note checklist, then blank sheets of lined paper can be used to supplement the writing
space. This may be necessary as each staff member who has contact with the participant, including the

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Study Coordinator, and Dentist must record separate progress notes about their interactions with the
participant.
D.3 Enrollment Visit progress note guidelines
Document that participant signed the informed consent and a copy was given to the participant.
Document that all CRFs were completed, or if some required CRFs were not completed, a list of
those CRFs along with the reason they were not completed.
Confirmation of eligibility.
A summary of conversations with participant.
Document the number of run-in mint bottles dispensed to the participant.
A list of any future appointments that are made at this visit, including restoration appointments
D.4 Baseline Visit progress note guidelines
Document that all CRFs were completed, or if some required CRFs were not completed, a list of
those CRFs along with the reason they were not completed.
Confirmation that the exam occurred and results of the exam if anything is of note. This note
should be recorded by the examiner.
Reconfirmation of eligibility at V1.
Confirmation that randomization was completed along with the assigned randomization number.
A summary of conversations with participant. This helps identify potential SAEs and provides
documentation of those SAEs for future reference. All SAEs reported using the study reporting
form should also be documented in the progress notes.
Document the number of bottles of mints dispensed to the participant.
A list of any future appointments that are made at this visit, including any additional restoration
visits.
D.5 Between visit contact progress note guidelines
Document that all CRFs were completed, or if some required CRFs were not completed, a list of
those CRFs along with the reason they were not completed.
Document the number of mint bottles sent to the participant.
A summary of conversations with participant. This helps identify potential SAEs and provides
documentation of those SAEs for future reference. All SAEs reported using the study reporting
form should also be documented in the progress notes.
A list of any future appointments that are made at this visit.
D.6 Annual/Final visit progress note guidelines
Document that all CRFs were completed, or if some required CRFs were not completed, a list of
those CRFs along with the reason they were not completed.
At the annual visits, document the number of bottles of mints dispensed to the participant.
At the final visit only, document the number of mints returned, if applicable.

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A summary of conversations with participant. This helps identify potential SAEs and provides
documentation of those SAEs for future reference. All SAEs reported using the study reporting
form should also be documented in the progress notes.
At the annual visits only, a list of any future appointments that are made at this visit.
At the final visit, a note that confirms that the participant has completed the study.
D.7 Between visit/contact progress note guidelines
There are times when you may have contact with participants or people involved with a participant (i.e.
spouse, parent, medical provider) between formal visits/contacts. These contacts need to be detailed in
the progress notes along with attempts to contact the participant that are unsuccessful. Some general
guidelines for these notes include:
Document any conversations with other people about the participant. This may include a
conversation with their spouse when you called their home number or a conversation with their
dental care provider about their restorations. Be sure that names of these people are never
included in the notes. Always refer to people by their relationship with the participant.
Document any between visit contacts or conversations with the participant. For example, if they
call to cancel their appointment or if a study team member calls them to make an appointment.
These notes should include a brief summary of the conversation and any resulting appointments
or cancellations.
Document any attempts to reach the participant that were unsuccessful. Include the date of the
attempt and whether a message was left or not.
There may be times when a participant calls to report an event in their life that is classified as an
SAE. In those instances, a very clear progress note should be recorded that details the
circumstances of the event and any resolution. The information should be detailed enough to
allow someone to fill out the SAE reporting. All SAEs reported using the study reporting form
should also be documented in the progress notes.
D.8 Error corrections in progress notes
Errors happen. Everyone makes them. The important thing is to know what to do about errors so that
they do not create questions about the integrity of the data record. Most importantly, if you make a
mistake and don't know what to do, consult with your supervisor or the DCC. Trying to guess your way
through a mistake can make it look like you are trying to cover something up. Almost all mistakes can be
handled, but it is important to deal with them directly.
Never correct other staffs progress notes. Always ask them to correct their own errors. If the staff
member is not available to make a correction, then add a note of your own to clarify their note (see
section D.9 for procedure for adding notes).
If you make a mistake while writing something on a CRF or in the Progress Notes, put a single line
through it in a different colored ink, initial and date beside that line, put in the correct information and
provide a brief explanation for the correction (e.g., wrong item checked).
Never cover up your mistakes by:
Scribbling over the mistake
Using White-Out or similar product
Re-writing over the top of the note

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Throwing away a progress note due to errors

D.9 Additions to progress notes
There are times when an addition to progress notes is necessary to fully document a visit. This may occur
when details are forgotten when the original note was recorded or to correct an error made by another
staff person in the progress note.
Never put any date, other than today's date, on a note (e.g., putting yesterday's date on a note because that
is the day that the data collection occurred). This is a form of data falsification. If you were unable to
complete documentation on the date that a research activity occurred, write a "late note." Never backdate.
This applies to notes or corrections added to forms as well as progress notes.
o Example: A late note for data collection that occurred on March 14, 2005, could be written:
3/20/05 Late note for 3/14/05. Participant completed the Medical History CRF. Staff
o Example: A late note for medication information that was forgotten when the original note was
recorded, could be written: 10/23/06 Late note for 10/22/06. Participant reported no new
medication usage at this visit. Staff
If a staff member makes an error in the progress notes and they are not available to make the correction
themselves, then staff should add a new progress note to clarify the error. A staff member would not be
available to make the correction because they left the study or are gone for an extended leave of
absence. If a staff member is only out for the day or gone for a vacation, then any corrections should be
held for that staff member to make.
o Example: A late note to correct a staff members misspelling of leukoplakia in a progress note
that they are not available to correct could be written as: 7/15/07 Note to correct 7/14/07
progress note to correct spelling of leukoplakia Staff
E. Study Material Storage
This section provides guidance on organizing the documents collected in the study. Each item on the
numbered list below designates a type of study material that needs to be retained among the study-related
materials in some form. How and exactly where these documents are stored at each site will vary based
on space limitations, accessibility, and institutional and Institutional Review Board (IRB) requirements.
The minimum standard is that all documents are maintained securely and that access to research records is
limited to personnel who are working on the study. Also, for this study, participant identifying information
must be filed separately from case report forms (CRFs).
There are several key issues to consider as you plan for storage:
Accessibility: Consider who will need access to each type of material and his or her ability to
access it. For example, if a clinician needs access to dental radiographs, then those radiographs
need to be stored in a space that the clinician can enter at will.
Human Subjects: Document storage should meet standards of your local IRB. Check with your
regulatory expert if you are unsure about your local standard.
Ease: Given how busy study staff may be, you need to make sure your organizational system
makes your life easier, not harder. Your organizational system should help you be more efficient
rather than hinder your efficiency. Think in terms of how often you will need to access the
information and how you will find what you need.
Separate Locations: The research chart and the consent chart need to be stored in separate,
secure locations. It is important to be sure each location has a separate lock. It is NOT sufficient
to use separate drawers within the same filing cabinet for these documents.

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Work to develop methods of storage that will effectively utilize the space and storage equipment you have
and will minimize hassle in quickly retrieving important documents.
F. Types of Documents
The following types of documents will be used for the XACT study:
1. Regulatory Files: Regulatory Files are the repository for a studys legally required documents.
All original study site approvals will be located in the Regulatory Files, as well as the Protocol,
regulatory and IRB documents (approvals and correspondence), a master copy of the informed
consent document(s), and study correspondence (protocol amendments and exceptions). Create a
regulatory binder for the XACT study and keep it up to date at all times. Participant-specific
information (e.g., signed consent forms and CRFs) should NOT be filed in the regulatory binder.
2. CRFs: CRFs are documents which contain data that will be entered into the database. Each
participant must have a research chart, separate from their consent chart, to hold completed CRFs.
The research chart is often organized by visit, with separate sections for non-visit information and
progress notes. For example, all CRFs collected at the enrollment visit may be stored under the
Enrollment tab; however their Mint Dispensing Log, which will be used at each visit, would be
stored in a non-visit section and their Enrollment Visit Progress Notes Checklist would be filed in
the progress notes section of their research chart. The research chart should NOT have the
participants name anywhere on or in the chart.
It is also useful to have a separate area for data that have yet to be entered; one approach is to
have an easily accessible folder or in-box labeled CRFs to be Entered so you dont have to look
through each research chart to find what needs to be entered. Another approach would be to have
a CRFs to be Entered tab in each participants research chart.
Research charts must be stored in a locked storage area, separate from the consent charts, to
prevent the accidental connection of participant identities with confidential research data.
3. Non-CRF Source Documents: Every participant will have non-CRF source documents collected
as a part of his or her participation in the study. These are documents that will not be entered into
the database. These documents should be filed in the research chart behind the appropriate visit
tab. An example of a non-CRF source document would be the Progress Notes Checklist for each
research visit. This document should be filed in the progress notes section of the research chart.
4. Consent Forms and Participant-Identifying Information: Each participant must have a
consent chart. All source documents that have participant -identifying information should be
stored in the consent chart. Examples of this type of document are signed consent forms,
Participant Contact Forms and Reimbursement Logs. These documents contain the participants
name and may contain other confidential participant information (e.g., names of other family
members that are suggested for helping to find a participant during contact attempts, name of
personal physician, participant signature).
The consent charts for all participants should be stored securely to maintain a high level of
confidentiality. Check with your local institution for specific storage requirements. At a
minimum, the consent forms must be stored in a different locked cabinet from the research chart
to prevent the accidental connection of the participant with his or her confidential research data. It
is NOT sufficient to use separate drawers within the same filing cabinet to file both consent charts
and research charts.
5. Participant Reimbursement (cash or gift certificates): Reimbursement for visits should be kept
in a lockbox or locked cabinet. The staff responsible for disbursing participant compensation
(e.g., Study Coordinator) should have access to the cash or gift certificates. The participant-

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specific compensation log should be stored in the participants consent chart since it contains the
participants name and signature.
6. Tracking Logs: Site-specific logs will be needed to track various aspects of the study (e.g., AE
events, mint inventory, protocol violations). These logs are used internally for tracking, and the
information on them is not entered into the data system. Some of these logs contain information
for multiple participants and thus cannot be filed in a particular participants chart. It is very
important that only the Participant ID number (and perhaps Name Code, if your site is using this
identifier) be recorded on these tracking logs. A separate binder should be created to store the
tracking logs for the study. These logs can be locked in the same storage area as research charts.
Logs used to track information on potential participants prior to enrollment, such as recruitment
logs, can contain identifying information. These logs should be stored in a locked area, as well.

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