Policy Practice and Regulatory Issues - 2012

Policy, Practice, and Regulatory Issues
Policy, Practice, and

Regulatory Issues
Anna Legreid Dopp, Pharm.D.
University of Wisconsin Hospital and Clinics
Madison, Wisconsin
ACCP Updates in Therapeutics® 2012: The Pharmacotherapy Preparatory Review and Recertification Course
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Learning Objectives:
1. Explain the prescription drug approval process of the U.S. Food and Drug Administration.
2. Identify implications for clinical research while adhering to institutional review board requirements.
3. List the purpose and function of an investigational drug service.
4. Describe national efforts aimed at improving and ensuring health care quality in the United States, including
the Joint Commission, National Committee for Quality Assurance, National Quality Forum, and Agency for
Healthcare Research and Quality.
5. Interpret legislative activity and regulatory opportunities for pharmacists.
OVERVIEW
The purpose of this review of policy, practice, and regulatory issues is to highlight areas of importance for clinical
pharmacists as they pertain to patient care outcomes and clinical research activity. Specifically, the rules and regula-
tions set forth by several agencies within the U.S. Department of Health and Human Services will be outlined.
I. THE U.S. FOOD AND DRUG ADMINISTRATION AND THE PRESCRIPTION DRUG APPROVAL PROCESS
A. Basics
1. The U.S. Food and Drug Administration (FDA) is the agency within the U.S. Department of Health
and Human Services (DHHS) responsible for the safety of most foods (human and animal) and cosmet-
ics, and it regulates both the safety and effectiveness of human drugs, biologics (e.g., vaccines, blood
and blood components), medical devices, and animal drugs.
2. Most federal laws giving the FDA this authority are provisions in and amendments to the Federal
Food, Drug, and Cosmetic Act (FD&C Act), and they are organized in the Code of Federal Regulations
(CFR) Title 21. The FDA is funded through discretionary spending every fall in Congress’s Appropria-
tions bill written by the Senate and House Appropriations Committees, but the Senate Health, Educa-
tion, Labor, and Pensions and the House Energy and Commerce Committees have jurisdiction over its
reauthorization.
3. It is organized by two offices, one research center, and six product centers:
a. Office of the Commissioner conducts overall agency coordination; the FDA’s top official, the
Commissioner, requires Senate confirmation.
b. Office of Regulatory Affairs, the largest office, regulates all inspection and enforcement activities.
c. National Center for Toxicological Research supports the six product centers with scientific tech-
nology, training, and technical expertise.
d. Center for Drug Evaluation and Research (CDER) regulates prescription and nonprescription drugs.
e. Center for Biologics Evaluation and Research regulates vaccines, blood, and gene therapy.
f. Center for Devices and Radiological Health regulates medical devices.
g. Center for Food Safety and Applied Nutrition regulates most foods, food additives, infant formu-
las, dietary supplements, and cosmetics.
h. Center for Tobacco Products regulates tobacco-containing products.
i. Center for Veterinary Medicine regulates feed, drugs, and devices used in pets, farm animals, and
other animals.
B. Definitions
1. The Abbreviated New Drug Application (ANDA) contains data that, when submitted to the FDA’s
CDER, Office of Generic Drugs, allows the review and ultimate approval of a generic drug product.
2. An authorized generic drug is a listed drug that is marketed, sold, or distributed directly or indirectly
to retail class of trade with labeling, packaging (other than repackaging as the listed drug in blister
packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name,
or trademark that differs from that of the listed drug.
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3. A biologics license application (BLA) is a submission that contains specific information on the manu-
facturing processes, chemistry, pharmacology, clinical pharmacology, and medical effects of a biologic
product (monoclonal antibodies, enzymes, immunomodulators, growth factors, and cytokines) seeking
approval to market in the United States.
4. A clinical trial is a research study of humans conducted to answer specific questions about vaccines,
new therapies, or new ways of using known treatments. Clinical trials required by the FDA seek to
determine whether new drugs or treatments are both safe and effective.
5. An Investigational New Drug (IND) application is used for a new drug, a new indication, or off-label
use that will be used in a clinical investigation’s preclinical development in order for that new drug to
be distributed across state lines before undergoing full FDA review.
6. A New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the
FDA approve a new pharmaceutical for sale and marketing in the United States.
C. History of the Regulation of Drugs and Human Subjects’ Research

1. Drug Importation Act of 1848, which prohibited the importation of unsafe or adulterated drugs at key
ports of entry
2. Biologics Control Act of 1902
a. Mandated annual licensing of establishments to manufacture and sell vaccines, sera, antitoxins,
and similar products in interstate commerce
b. Authorized Hygienic Laboratory, precursor to the National Institutes of Health (NIH), to conduct
regular inspections for purity and potency
3. Pure Food and Drug Act of 1906
a. Prohibited interstate commerce of adulterated or misbranded drugs
b. Required labeling of selected dangerous and addictive substances
c. Identified United States Pharmacopoeia and the National Formulary as official standards for drugs
4. Food, Drug, and Cosmetic Act of 1938
a. Required that firms prove evidence of safety to the FDA before marketing
b. Placed drug advertising under the jurisdiction of the Federal Trade Commission
5. Durham-Humphrey Amendment of 1951: Amended the FD&C Act of 1938 to statutorily differentiate
prescription and nonprescription drugs
6. Kefauver-Harris Amendments of 1962
a. Established the requirement for drug firms to demonstrate efficacy as well as safety
b. Statutory requirement to obtain informed consent for research subjects
c. Authorized the FDA to regulate advertising of prescription drugs and establish good manufactur-
ing practices
7. The Orphan Drug Act of 1983 established grants, federal assistance for research, and tax incentives to
develop drugs targeted for a patient population of less than 200,000.
8. The Food and Drug Administration Act of 1988 officially established the FDA as an agency in DHHS.
9. Prescription Drug User Fee Act (PDUFA) of 1992
a. Requires drug, biologics, and medical device (MDUFA) manufacturers to pay fees for product ap-
plications, supplements, and other services
b. Reauthorized every 5 years (1997, 2002, 2007)
10. The Dietary Supplement Health and Education Act of 1994 allows nutritional supplements and vita-
mins to be regulated.
11. FDA Modernization Act of 1997
a. Streamline clinical research on drugs and devices
b. Exclusivity provisions for pediatric drugs
c. Authorizes the creation of a databank (ClinicalTrials.gov) to provide easy access to information on
federally and privately supported clinical trials for a wide range of diseases and conditions
i. Provides abstracts of clinical study protocols that investigators are required to submit
(a) Summary and purpose of study
(b) Recruiting status
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(c) Criteria for patient participation

(d) Location for trial and specific contact information
(e) Research study design
(f) Phase of trial
(g) Disease or condition and drug or therapy under study
ii. More than 115,000 clinical trials have been listed in over 170 countries.
12. Food and Drug Administration Amendments Act of 2007 (FDAAA)
a. Vehicle for reauthorizing PDUFA
b. Statutory authority to require Risk Evaluation Mitigation Strategies (REMS)
13. The Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate
tobacco products.
14. The Patient Protection and Affordable Care Act of 2010 established a regulatory approval pathway for
biosimilars or follow-on biologics.
15. The Reducing Prescription Drug Shortages Executive Order was signed by President Barack Obama on
October 31, 2011. It requires the FDA to:
a. Broaden reporting of manufacturing discontinuances that may lead to shortages of drugs that are
life supporting or life sustaining or that prevent debilitating disease;
b. Expedite regulatory review to avoid or mitigate existing or potential drug shortages. Reviews may
include new drug suppliers, manufacturing sites, and manufacturing changes; and
c. Communicate to the Department of Justice any evidence of or behaviors by market participants
that have contributed to stockpiling or exorbitant prices.
D. Prescription Drug Approval Path

1. Preclinical studies
a. Laboratory and animal studies that assess safety and biologic activity in various model systems
i. ED50 is the amount of drug required to produce a specific effect in 50% of animals tested.
ii. LD50 is the amount of drug required to cause death in 50% of animals tested.
b. Toxicologic studies completed
i. Effects on the fetus in pregnant mice, rats, rabbits, or baboons
ii. May or may not translate into human fetal adverse effects
iii. Fetal effects in humans may occur that were not observed in animal studies.
iv. Basis for pregnancy categories B, C, and some D
c. An IND application is drafted and submitted to the FDA.
2. Phase I drug trial
a. Initial introduction of an IND into humans, typically 20–100 healthy volunteers
b. Goal is to garner information on the pharmacokinetic and pharmacodynamic properties of the
investigational drug to design a well-controlled and robust phase II trial.
3. Phase II drug trial
a. Controlled clinical studies conducted in no more than several hundred subjects
b. Goal is to evaluate the drug’s effectiveness for a particular indication in patients with the disease
or condition under investigation and to determine the common short-term adverse effects and risks
associated with the drug.
4. Phase III drug trial
a. Involves the administration of the investigational drug to a range of several hundred to several
thousand patient subjects in different clinical settings to determine its safety, efficacy, and appro-
priate dosage
b. Goal is to gather necessary additional information about effectiveness and safety for evaluating the
overall benefit-risk relationship of the drug and to provide an adequate basis for physician label-
ing.
c. The step before the sponsor’s submitting an NDA to the FDA for approval to market the drug
d. Once an NDA is submitted, it is classified with a code that reflects both the type of drug being
submitted and its intended uses. The numbers 1–7 are used to describe the type of drug:
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i. New Molecular Entity (1)

ii. New Salt of Previously Approved Drug (2)
iii. New Formulation of Previously Approved Drug (3)
iv. New Combination of Two or More Drugs (4)
v. Already Marketed Drug Product (i.e., new manufacturer) (5)
vi. New indication for currently marketed drug or switch from prescription to over the counter (6)
vii. Already marketed drug product without a previously approved NDA (7)
e. Letter code describes the review priority of the drug
i. S = standard review for drug similar to currently available drugs
ii. P = priority review for drugs that represent significant advances over existing treatments
f. Not all phase III drugs are approved, and the FDA can impose a clinical hold at any stage.
Table 1. Components of the NDAa
Index Nonclinical pharmacology and toxicology

Summary Human pharmacokinetics and bioavailability
Chemistry, manufacturing, and control Microbiology (for antimicrobial drugs only)
Samples, methods, and labeling Clinical data
Safety update report
b
Case report forms
Statistical analysis Patent information
Case report tabulations Patent certification
Other pertinent information
a
NDA = New Drug Approval.
b
The safety update report is usually submitted 120 days after the NDA submission.
5. Phase IV drug trial

a. Also referred to as postmarketing studies
b. May be required by the FDA to identify additional information about the drug’s risks, benefits, and
optimal use
c. Verify effectiveness or focus treatment on special populations
E. Generic Drugs
1. Around 69% of all drugs dispensed are generic.
2. A generic drug product is one that is identical (bioequivalent) to an innovator drug product in dosage
form, strength, route of administration, quality, performance characteristics, and intended use. The
Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman
Act, defined bioequivalence statutorily as a means to approve a generic drug.
3. Once an ANDA is submitted to and approved by CDER’s Office of Generic Drugs, the applicant can
manufacture and market the generic drug as a safe, effective, and low-cost option to the public.
4. All approved products are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence
Evaluations (Orange Book).
5. ANDAs generally do not require preclinical or clinical data, but rather, they must demonstrate bio-
equivalence.
6. Pharmaceutical equivalents
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Table 2. Criteria for Medications to be Pharmaceutical Equivalents
Three criteria:
• Must contain the same active ingredient
• Must be the same dosage form
• Must be of identical strength or concentration
Differences allowed:
• Shape
• Releasing mechanism
• Labeling (limited differences)
• Scoring
• Excipients (colors, flavors, preservatives)
7. Therapeutic equivalents can be substituted with the expectation that the substituted product will pro-
duce the same clinical effect and safety profile as the prescribed product.
a. Criteria
i. Pharmaceutical equivalent
ii. Therapeutic equivalence codes rated “A” by the FDA
b. Assigns therapeutic equivalence code on the basis of data submitted in an ANDA to demonstrate
bioequivalence
i. ANDA contains adequate scientific evidence establishing through in vivo and/or in vitro stud-
ies of bioequivalence of the product to the reference listed drug.
ii. Products deemed by the FDA not therapeutically equivalent are “B” rated.
8. An authorized generic is a prescription drug produced by the brand pharmaceutical company and
marketed at generic prices during and after the 180-day exclusivity period that is identical to the brand
alternative both in active and inactive ingredients.
9. At-risk launch of a generic occurs when a generic drug manufacturer challenges the validity of the
existing patent of a brand drug.
10. Follow-on biologics or biosimilars are drugs or vaccines that have been produced in living cells.
a. Biosimilars are approved new versions of an innovator biopharmaceutical product after patent ex-
piration; this is a fairly controversial area between the government, industry, and patient advocacy
organizations.
b. Legislation has created a statutory pathway for the FDA to approve these products after 12 years
of data exclusivity for the manufacturer of a new biologic product.
F. Medical Devices
1. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar
or related article, including a component part, or accessory that is:
a. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supple-
ment to them
b. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treat-
ment, or prevention of disease, in humans or other animals
c. Intended to affect the structure or any function of the body of humans or other animals that does
not achieve any of its primary intended purposes through chemical action within or on the body
of human beings or other animals and that is not dependent on being metabolized for the achieve-
ment of any of its primary intended purposes
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2. Regulated by the Center for Devices and Radiological Health (CDRH)

a. To be approved, a medical device company must submit a premarket approval (PMA) application
ensuring the device’s safety and efficacy.
b. If a medical device is substantially equivalent to an existing, legally marketed device, a 510(k) is
submitted for premarket notification.
c. An investigational device exemption (IDE) allows an investigational device to be used in a clini-
cal study to collect the safety and effectiveness data required to support a PMA application or a
premarket notification 510(k) submission to the FDA.
3. Classified according to the risks associated with the device:
a. Class I – Deemed low risk and therefore subject to the least regulatory control
b. Class II – Higher-risk devices than class I that require greater regulatory controls to ensure reason-
able safety and efficacy
c. Class III – Highest-risk devices, subject to the greatest regulatory control; must be approved by the
FDA before marketing
G. Risk Evaluation and Mitigation Strategies

1. Replaces the Risk Minimization Action Plans (RiskMAPs)
2. Requirements that a drug be dispensed with one of the following:
a. Medication guide and/or patient package inserts
b. Communication plan to health care providers
c. Elements to ensure safe use
Table 3. Risk Evaluation and Mitigation Strategies’ Requirements of Elements to Ensure Safe Use
Elements to Ensure Safe Use may include one of the following:
• Health care providers who prescribe the drug have particular training or experience or are specially certified
• Pharmacies, practitioners, or health care settings that dispense the drug are specially certified
• Drug dispensed only in certain health care settings
• Drug dispensed to patients with evidence of safe-use conditions, such as laboratory test results
• Each patient using the drug is subject to monitoring
• Each patient using the drug is enrolled in a registry
3. The FDA does not have the authority to impose penalties on pharmacies and pharmacists not in com-
pliance with REMS requirements, but there may be legal implications such as misbranding violations
or civil liability issues.
H. MedWatch Through the FDA Is a Voluntary Safety Information and Adverse Event Reporting Program.
I. Critical Path Initiative

1. Created in response to a significant decline in NDAs, BLAs, and medical device applications because
of the widening gap between basic science discovery and the challenging, inefficient, and costly devel-
opment of medical product development
2. Prioritizes the most pressing development problems and identifies areas that provide the greatest op-
portunities for rapid improvement and public health benefit through three dimensions:
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Table 4. U.S. Food and Drug Administration’s Critical Path Initiative

Dimension Definition Example of Activities
Assessing safety Show that the product is • Preclinical: Show that product is safe enough for human
adequately safe for each testing
stage of development • Eliminate products with safety problems early
• Clinical: Show that the product is safe enough for
commercial distribution
Demonstrating Show that the product • Preclinical: Select appropriate design (devices) or candidate
medical utility benefits people (drugs) with high probability of effectiveness
• Clinical: Show effectiveness in people
Product Go from laboratory • Design a high-quality product
industrialization concept or prototype to a - Physical design, characterization, specifications
manufacturable product • Develop mass production capacity
- Manufacturing scale-up, quality control
II. INSTITUTIONAL REVIEW BOARD (IRB) IMPLICATIONS FOR CLINICAL PRACTICE AND RESEARCH
A. Basics
1. Every institution that conducts or supports biomedical or behavioral research involving human
participants must, by federal regulation, have an IRB that initially approves and periodically reviews
research protocols to protect the rights of human participants.
2. Governed by DHHS Office for Human Research Protections (OHRP) regulations at Title 45 CFR Part
46; requires the IRB or ethics committee to protect the rights, safety, and well-being of all study subjects.
Specifically, Subpart A constitutes the Federal Policy (Common Rule) for the Protection of Human
Subjects.
3. IRB approval is required for interventional and observational studies, and applications must be
reviewed annually.
B. Definitions
1. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 provides protection for the
privacy of certain individually identifiable health data, referred to as protected health information (PHI).
2. Human subject means a living individual about whom an investigator conducting research obtains 1) data
through intervention or interaction with the individual or 2) identifiable private information.
3. Informed consent is the process of learning the key facts about a clinical trial before deciding whether to
participate.
4. An informed consent document describes the rights of the study participants and includes details about
the study including purpose, duration, required procedures, risks, benefits, and key contacts.
5. An IRB is a committee of physicians, statisticians, researchers, community advocates, and others that
ensures that a clinical trial is ethical and the rights of study participants are protected.
6. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research
are not greater in and of themselves compared with those ordinarily encountered in daily life or during
the performance of routine physical or psychological examinations or tests.
C. The IRB is composed of at least five members with varying backgrounds to promote complete and adequate
review of research activities while adhering to institutional commitments and regulations, applicable law,
and standards of professional conduct and practice.
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1. The committee must be sufficiently qualified through the experience, expertise, and diversity of its
members, including race, gender, cultural background, and sensitivity to issues such as community
attitudes, to promote respect for its advice and counsel.
2. At least one member whose primary concerns are in scientific areas
3. At least one member whose primary concerns are in nonscientific areas
4. At least one member who is not affiliated with the institution and who is not an immediate family
member of a person affiliated with the institution
D. Human Subjects’ Training

1. Institution-specific
2. A Collaborative Institutional Training Initiative (CITI) program is a subscription-based service that
provides research ethics training to its members.
E. Research Exempt from IRB Requirements

1. Research conducted in established or commonly accepted educational settings, involving normal
educational practices, such as
a. Research on regular or special education instructional strategies
b. Research on the effectiveness of the comparison among instructional techniques, curricula, or
classroom management methods
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement),
survey procedures, interview procedures, or observation of public behavior, unless:
a. Information obtained is recorded in a manner that human subjects can be identified, directly or
through identifiers linked to the subjects, and
b. Any disclosure of the human subjects’ responses outside the research could reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing,
employability, or reputation
3. Research involving the collection or study of existing data, documents, records, pathologic specimens,
or diagnostic specimens; if these sources are publicly available or if the information is recorded by the
investigator in a manner such that subjects cannot be identified, directly or through identifiers linked to
the subjects
4. Research involving no more than minimal risk, and minor changes made to approved research
protocols, may be considered for expedited review.
F. The HIPAA Privacy Rule Supplements and Expands the Common Rule Regulation of Human Subjects’
Research.
1. Protections for the confidentiality of PHI used in clinical practice, research, and the operation of health
care facilities
2. PHI includes information that:
a. Is created or received by a covered entity, which includes a health care provider, and
b. Pertains to the past, present, or future physical or mental health, or condition of the individual, or
c. Pertains to payment for the individual’s health care, or
d. Pertains to the provision of health care in the past, present, or future, and
e. Identifies an individual or could be used for identifying an individual
3. To use or disclose PHI for research purposes, one or more of the following actions must be taken:
a. Written authorization specifically for the use and disclosure of PHI for research purposes
involving human subjects;
b. Waiver of authorization approved by an IRB – Use of de-identified information or limited data
sets (limited data set [45 CFR §164.514(e)] defined for research, public health, and health care
operations);
c. Preparatory to research certifications; and/or
d. Database registration
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4. A provision within HIPAA also mandated the adoption of a standard unique identifier for health
care providers. The National Plan & Provider Enumeration System of the Center for Medicare &
Medicaid Services (CMS) collects information from providers and assigns each a unique National
Provider Identifier.
G. Typical Documents Submitted to the IRB for an Initial Review. Examples of these documents can be
found at NIH’s National Institute on Aging Clinical Study Investigator’s Toolbox.
Table 5. Documents That May Need to Be Submitted to an IRB for Initial Review
Cover sheet Recruitment materials
Conflict of interest assessment Surveys, questionnaires, other instruments
Application Federal grant, if applicable
Formal protocol Documentation of IRB approval from another institution
Informed consent forms Data and safety monitoring plan
HIPAA authorization forms Additional supportive documents as requested by IRB
HIPAA = Health Insurance Portability and Accountability Act; IRB = institutional review board.
H. Informed Consent
1. Basic elements
a. A statement that the study involves research, an explanation of the purposes of the research, the
expected duration of the subject’s participation, a description of the procedures to be followed, and
the identification of any procedures that are experimental
b. A description of any reasonably foreseeable risks or discomforts to the subject
c. A description of any benefits to the subject or to others that may reasonably be expected from the
research
d. A disclosure of appropriate alternative procedures or courses of treatment that might be advanta-
geous to the subject
e. A statement describing the extent to which confidentiality of records identifying the subject will be
maintained
f. For research involving more than minimal risk, an explanation regarding whether there is any
compensation and an explanation regarding whether any medical treatments are available if injury
occurs and, if so, what they consist of, or where further information may be obtained
g. An explanation of whom to contact for answers to pertinent questions about the research and
research subjects’ rights and of whom to contact in the event of a research-related injury to the
subject
h. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled, and the subject may discontinue participation at
any time without penalty or loss of benefits to which the subject is otherwise entitled
2. Waiver will be considered if
a. Research involves no more than minimal risk to subjects;
b. The waiver or alteration will not adversely affect the rights and welfare of subjects;
c. The research could not practicably be carried out without the waiver or alteration; and
d. Where appropriate, the subjects will be provided with additional pertinent information after par-
ticipation.
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Template for Combined Informed Consent and HIPAA Authorization Form
NAME OF INSTITUTION
Subject CONSENT to Participate in Research
And
AUTHORIZATION to Use and/or Disclose Identifiable Health information for Research
Title of the Study: Title of Research Protocol
Principal Investigator: Include name of PI (PI contact telephone number) (PI contact e-mail)
Mailing Address: Provide PI contact mailing address
INVITATION
You are invited to participate in this research study about: Provide brief description of research in terms under-
standable to a layperson.
You are invited to take part because you: Describe why the person is being asked to participate as a research
subject in the study. Give an approximation of the number of individuals who will participate in the study.
Your participation in this research study is voluntary. If you decide not to participate, the health care provided to
you by the insert institution name will not be affected in any way.
A. WHAT IS THE PURPOSE OF THIS STUDY?
Provide a clear explanation of the purpose of the research
B. WHAT WILL MY PARTICIPATION INVOLVE?
Describe in lay terms what procedures the research participant will be required to take part in during the
research. List how many questionnaires, surveys, or interviews they will be required to complete and the amount
of time it may take.
We will also collect the following information about you for this research study:
1. From you: List the demographic information that you will collect from the subject (i.e., birth date, home ad-
dress, phone number, e-mail address). List the health information that you will collect from the subject (i.e. diet,
exercise habits, use of tobacco, use of alcohol).
2. From your medical records, health records (such as x-rays), and/or billing records: List the information from
the subjects’ medical or other health or billing records that will be used for this research.
3. From medical tests or other procedures performed for this study: List the medical tests or other procedures
that will be performed for this study and the information generated by each (e.g., white blood cell count from
blood test).
C. ARE THERE ANY BENEFITS TO ME?
List any benefits to the subject in a way that is not coercive, enticing, or self-serving. This section should in-
clude a statement that there may be no benefit to the subject.
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D. WILL I BE PAID FOR MY PARTICIPATION?
Describe compensation for participating in this study.
E. ARE THERE ANY SIDE EFFECTS OR RISKS TO ME?
Describe, in terms understandable to a layperson, any risks to research participants. This could include health
risks and/or psychosocial risks including breach of confidentiality resulting in legal issues, and insurability and
employability problems. Example: “The main risk of taking part in this study is that your study information
could become known to someone who is not involved in performing or monitoring this study.”
F. HOW WILL MY PRIVACY BE PROTECTED AND WHO WILL USE MY HEALTH INFORMA-
TION?
Sample statement: The information collected from you during this study and from your medical records will be
used by the researchers and research staff of at this institution for this study. It may also be shared with others
outside of this institution.
Describe how research data will be kept confidential by the investigator. Specify the measures that will be
implemented by your research group to safeguard the PHI from unauthorized use or disclosure. For paper
forms of PHI, your plan should address, at least, the following: Locking up your research files while they are
unsupervised, shredding excess copies of paper documents, protections for codes that link patients to their
data. For electronic forms of PHI, plan should address, at least, the following: Workstation locks that secure a
user’s computer from unauthorized access when not in use, defining the electronic location where PHI will be
stored and the technical security measures in place to protect the data while it is stored there, authentication
requirements to access the PHI, including whether authentication occurs at the network, device, folder or file
level, audit trails to record accesses or changes to data, and transmission protocols that assure data cannot be
intercepted while in transit If PHI is to be disclosed outside your institution, describe the plans of any research
collaborators to protect the PHI you will share with them.
List others inside and outside the institution of record who may need to use PHI in the course of the research
protocol (i.e. Institutional regulatory and research oversight boards and offices, Accounting and billing person-
nel)
Certificate of Confidentiality
Sample statement: To help us protect your privacy, we have obtained a Certificate of Confidentiality from the
National Institutes of Health. With this Certificate, the researchers cannot be forced to disclose information that
may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legisla-
tive, or other proceedings. The researchers will use the Certificate to resist any demands for information that
would identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the United States Gov-
ernment that is used for auditing or evaluation of Federally funded projects or for information that must be
disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family
from voluntarily releasing information about yourself or your involvement in this research. If an insurer, em-
ployer, or other person obtains your written consent to receive research information, then the researchers may
not use the Certificate to withhold that information.
The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without your
consent, information that would identify you as a participant in the research project in certain circumstances.
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G. IS MY PERMISSION VOLUNTARY AND MAY I CHANGE MY MIND?
Your permission is voluntary. You do not have to sign this form and you may refuse to do so. If you refuse to
sign this form, however, you cannot take part in this research study.
You may completely withdraw from the study at any time. You also may choose to cease participation or skip
any questions that you do not feel comfortable answering.
H. HOW LONG WILL MY PERMISSION TO USE MY HEALTH INFORMATION LAST?
By signing this form you are giving permission for your health information to be used by and shared with the
individuals, companies, or institutions described in this form. Unless you withdraw your permission in writing
to stop the use of your health information, there is no end date for its use for this research study. You may with-
draw your permission at any time by writing to the person whose name is listed below:
Include name of PI and PI contact mailing address
Beginning on the date you withdraw your permission, no new information about you will be used. Any infor-
mation that was shared before you withdrew your permission will continue to be used. If you withdraw your
permission, you can no longer actively take part in this research study.
I. WHO SHOULD I CONTACT IF I HAVE QUESTIONS?
Please take as much time as you need to think over whether or not you wish to participate. If you have any
questions about this study at any time, contact the Principal Investigator: Include name of PI and contact tele-
phone number.
If you are not satisfied with response of research team, have more questions, or want to talk with someone about
your rights as a research participant, contact: Insert institution’s patient relations representative (or title specific
to the institution) and provide telephone number
AGREEMENT TO PARTICIPATE IN THIS STUDY
AND
PERMISSION TO USE AND/OR DISCLOSE MY HEALTH INFORMATION
I have read this consent and authorization form describing the research study procedures, risks, and benefits,
what health information will be used, and how my health information will be used. I have had a chance to ask
questions about the research study, including the use of my health information, and I have received answers to
my questions. I agree to participate in this research study, and permit the researcher to use my health informa-
tion as described above.
Name of Participant (please print):________________________________
YOU WILL RECEIVE A COPY OF THIS FORM AFTER SIGNING IT.
Signature of participant: ___________________________________________________ Date: __________
Signature of person obtaining consent and authorization:_______________________ Date: __________
Include date of version and leave room for IRB stamp of approval according to institution’s specifications
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III. INVESTIGATIONAL DRUG SERVICE (IDS)
A. Basics
1. The American Society of Health-System Pharmacists Policy on Institutional Review Boards and Inves-
tigational Use of Drugs (0711) strongly supports pharmacists’ management of the control and distribu-
tion of drug products used in clinical research.
2. The purpose of an IDS is to procure, manage, prepare, dispense, and dispose of investigational drugs
according to protocol and in compliance with the state and federal requirements that govern investiga-
tional drug activities.
B. Definitions – Drugs, as defined by the FD&C Act, are “(A) articles intended for use in the diagnosis,
cure, mitigation, treatment, or prevention of disease, and (B) articles (other than food) intended to affect
the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)]. An
investigational drug is a chemical or biologic substance that has been tested in a laboratory and been
approved by the FDA to be tested in human subjects. An investigational (also referred to as experimental)
drug may be:
1. A new chemical or compound that has not been approved by the FDA for general use or
2. An approved drug undergoing further investigation for an approved or unapproved indication, dose,
dosage form, administration schedule, or under an IND application in a controlled, randomized, or
blinded clinical trial
C. In addition to the regulations outlined by the Office of Human Research Protection (Common Rule)
and the FDA to conduct research in accordance with the principles of good clinical practice and human
subjects’ protection, there are federal and state requirements of an IDS:
1. The Joint Commission Standards require policies for the use of investigational drugs that specifically
address their storage, dispensing, labeling, and distribution.
2. The Environmental Protection Agency and Occupational Safety and Health Administration regulate the
disposal of investigational drugs.
3. The American Society of Health-System Pharmacists provides practice standards.
4. The local IRB
5. State-specific laws may vary.
D. A Study-Specific Notebook Is Maintained Where Study Drugs Are Stored. It contains the following files
and contents:
Table 6. Example of Documents Stored in Study-Specific Notebooks Maintained by an Investigational Drug Service
File Section Contents
Protocol Copy of the research protocol
Drug information Investigator’s brochure, drug data sheet, package inserts (if commercially available)
Pharmacy procedures Study-specific pharmacy procedure information
Logs/forms/labels Study-specific materials
Procurement details Receipt and disposition records
Correspondence Correspondence
Computer matters Copies of order entry codes
Billing Financial agreements with investigator
IRB IRB submission application, approval, and consent forms
Miscellaneous Miscellaneous documentation
Master patient log Record of patients enrolled
Drug accountability records Data accountability record for each drug/dosage form/package size/strength
IRB = institutional review board.
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E. In addition to managing the activities outlined under the purpose of an IDS, an investigational drug
pharmacist’s duties may include
1. Participating in IRB as a voting member
2. Maintaining a working relationship with the IRB, Pharmacy and Therapeutics Committee, principal
investigators, and the pharmacy department
3. Reviewing new and existing investigational drug study protocols
4. Meeting with investigators, study monitors, and other study personnel responsible for coordinating the
logistics of a clinical trial
5. Receiving, organizing, and maintaining the contents of study notebooks
6. Providing randomization, blinding, or control functions of a clinical trial
7. Conducting the training of IDS staff and personnel regarding investigational protocols and study drug
procedures
IV. THE JOINT COMMISSION, NATIONAL COMMITTEE FOR QUALITY ASSURANCE (NCQA),
NATIONAL QUALITY FORUM (NQF), AGENCY FOR HEALTHCARE RESEARCH AND
QUALITY (AHRQ), AND PHARMACY QUALITY ALLIANCE (PQA)
A. The programs outlined in this section are not federal regulatory programs, but they play an important role
in the pharmacist’s ability to provide patient-centered, safe, and effective care.
B. The Joint Commission is a not-for-profit, independent organization that sets standards for accrediting
health care facilities through its mission “to continuously improve health care for the public, in
collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel
in providing safe and effective care of the highest quality and value.”
1. Basics
a. Accredits and certifies more than 19,000 health care organizations in the United States
b. Standards address an organization’s performance in functional areas of patient rights, patient
treatment, medication safety, and infection control. Hospitals provide data from a selection of 57
inpatient measures.
2. Definitions
a. National Patient Safety Goals were established to help accredited organizations address specific
areas of concern in patient safety in the areas of ambulatory health care, behavioral health care,
critical access hospital, home care, hospital, laboratory, long-term care, Medicare/Medicaid long-
term care, and office-based surgery.
b. ORYX is a Joint Commission performance measurement and improvement initiative implemented
to integrate outcomes with accountability measures in the areas of acute myocardial infarction,
heart failure, pneumonia, surgical care improvement project, children’s asthma care, perinatal,
hospital outpatient measures, venous thromboembolism, hospital-based inpatient psychiatric ser-
vices, and stroke in its accreditation process.
i. Common standardized measures between the Joint Commission and the CMS are called Na-
tional Hospital Quality Measures.
ii. Accountability measures and processes that result in the greatest improvement in patient out-
comes have been identified by the Joint Commission. These measures and processes must be
of sound scientific evidence, have close proximity between process and outcome, accurately
measure the process, and minimize adverse effects without inducing unintended consequenc-
es. Measures are updated frequently. Examples of current inpatient measures are listed below.
(a) Acute myocardial infarction
(1) Aspirin at arrival
(2) Aspirin at discharge
(3) Angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker
(ARB) at discharge
2-289
(4) β-Blocker at discharge

(5) Fibrinolytic therapy within 30 minutes
(6) Primary PCI (percutaneous coronary intervention) balloon within 90 minutes
(7) Smoking cessation advice/counseling
(b) Heart failure care requiring an ACE inhibitor or ARB at discharge
(c) Pneumonia care
(1) Pneumococcal vaccination
(2) Blood culture in emergency department
(3) Antibiotics for immunocompetent patients
(4) Influenza vaccination
(d) Surgical care (Surgical Care Improvement Project [SCIP])
(1) Antibiotics within 1 hour before the first surgical cut
(2) Appropriate prophylactic antibiotics
(3) Discontinuing antibiotics within 24 hours
(4) Cardiac patients with controlled 6 a.m. postoperative blood glucose
(5) Patients with appropriate hair removal
(6) β-Blocker patients who received β-blocker perioperatively
(7) Prescribing venous thromboembolism prophylaxis
(8) Receiving venous thromboembolism prophylaxis
(e) Children’s asthma care
(1) Relievers for inpatient asthma
(2) Systemic corticosteroids for inpatient asthma
(3) Home management plan of care given to patient/caregiver
c. Targeted Solutions Tool, created by the Joint Commission Center for Transforming Healthcare,
provides a process for accredited hospitals to measure performance, identify barriers to excellent
performance, and implement proven solutions.
d. Tracer methodology is a process used by an on-site surveyor to evaluate a patient’s medical record
as a road map to move through a health care organization to assess and evaluate its compliance
with standards and systems to provide care and services. First-generation tracers follow a patient
through care areas, whereas second-generation tracers focus on major organizational areas such as
high-alert medications or medication shortages.
C. The NCQA is a private, not-for-profit organization with a mission to improve the quality of health care
through measurement, transparency, and accountability.
1. Basics
a. Offers accreditation programs, certification programs, physician recognition programs, and dis-
tinctions that apply to health plans, such as health maintenance organizations, preferred provider
organizations, and consumer-directed health plans, physician networks, medical groups, and indi-
vidual physicians.
b. Produces several public reports including “The State of Health Care Quality,” which is an overall
assessment of the performance of the American health care system; “America’s Best Health Plans”
in collaboration with U.S. News & World Report; and the online Health Plan Report Card with a
searchable database detailing health plans’ accreditation and performance ratings.
2. Definitions
a. The Healthcare Effectiveness Data and Information Set (HEDIS) is a tool that consists of 75
measures across eight domains of care that health plans use to measure performance and focus
improvement efforts.
i. Measures are developed by identifying the clinical area to evaluate; conducting an extensive
literature review; developing the measure; vetting it with various stakeholders; and perform-
ing a field test that evaluates feasibility, reliability, and validity.
ii. Domains
(a) Asthma medication use
(b) Persistence of β-blocker treatment after a heart attack
(c) Controlling high blood pressure
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(d) Comprehensive diabetes care

(e) Breast cancer screening
(f) Antidepressant medication management
(g) Childhood and adolescent immunization status
(h) Advising smokers to quit
b. NCQA will establish criteria for Accountable Care Organizations (ACOs), created by the Patient
Protection and Affordable Care Act of 2010. Principles of ACOs include:
i. Strong foundation of primary care;
ii. Reliable reporting of measures to support quality improvement and to eliminate waste and
inefficiencies to reduce cost;
iii. Commitment to improving quality and patient experience while reducing per capita costs;
iv. Collaborate with stakeholders in a community or region; and
v. Create and support a sustainable workforce.
D. NQF is a nonprofit organization that aims to improve quality through a three-part mission: setting national
priorities and goals for performance improvement; endorsing national consensus standards for measuring
and publicly reporting on performance; and promoting the attainment of national goals through education
and outreach programs. Basics:
1. Membership includes stakeholders from consumer organizations, public and private purchasers, physi-
cians, nurses, accrediting and certifying bodies, supporting industries, and health care research and
quality improvement organizations.
2. Through the passing of the Medicare Improvements for Patients and Providers Act of 2008, DHHS
entered into a contract with NQF to establish a portfolio of quality and efficiency measures for use in
reporting on and improving health care quality for the federal government to determine a return on
investment on health care spending.
a. Formulation of a national strategy and priorities for health care performance measurement in order
to review and synthesize evidence related to 20 high-priority conditions identified by CMS that
account for more than 95% of their costs
b. Implementation of a consensus process for endorsement of health care quality measures
c. Maintenance of consensus-endorsed measures
d. Promotion of electronic health records (EHRs)
e. Focused measurement of the development, harmonization, and endorsement efforts to fill critical
gaps in performance measurements
E. The Agency for Healthcare Research and Quality

1. Basics
a. The agency within DHHS that supports research that helps people make more informed decisions
and improves the quality of health care services through its mission to improve the quality, safety,
and effectiveness of health care for all Americans
b. Health services research provides clinical, health care system, and public policy decision-makers
evidence-based information on health outcomes, quality, cost, use, and access to improve the qual-
ity of health care services.
2. Definitions
a. Comparative effectiveness research (CER) is the conduct and synthesis of systematic research
comparing different interventions and strategies to prevent, diagnose, treat, and monitor health
conditions. The concept of CER was introduced in the Medicare Modernization Act of 2003, but
it received more funding and attention in the American Recovery Act of 2009 when the Federal
Coordinating Council for Comparative Effectiveness was established. It is composed of mem-
bers from DHHS agencies such as the AHRQ, FDA, NIH, CMS, Centers for Disease Control and
Prevention, Office of Minority Health, Office of the National Coordinator, Health Resources and
Services Administration, and Substance Abuse and Mental Health Services and from the Veterens
Health Administration and Department of Defense.
2-291
b. Consumer Assessment of Healthcare Providers and Systems (CAHPS)

c. The Effective Health Care Program funds individual researchers, research centers, and academic
organizations to work together with the AHRQ to produce effectiveness and the CER for clini-
cians, consumers, and policy-makers.
d. Health services research, according to the Institute of Medicine, is a multidisciplinary field of
inquiry, both basic and applied, that examines the use, costs, quality, accessibility, delivery, orga-
nization, financing, and outcomes of health care services to increase knowledge and understanding
of the structure, processes, and effects of health services for individuals and populations.
F. The PQA
1. Basics
a. The mission of PQA is to improve the quality of medication use across health care settings through
a collaborative process in which key stakeholders agree on a strategy for measuring and reporting
performance information related to medications.
b. Developed performance measures including proportion of days covered, gap in medication
therapy, diabetes medication dosing, suboptimal treatment of hypertension in patients with diabe-
tes, use of high-risk medications in the elderly, drug-drug interactions, and medication therapy for
individuals with asthma.
2. Demonstration projects have been funded across the country.
V. LEGISLATIVE ACTIVITY INTO REGULATORY POLICY
A. The American Recovery and Reinvestment Act (ARRA) of 2009 provided a vehicle for passing the Health
Information Technology for Economic and Clinical Health (HITECH) Act, which authorized DHHS
to create programs to improve health care quality, safety, and efficiency through the promotion of HIT,
including EHRs.
1. Created the Office of the National Coordinator to coordinate nationwide implementation efforts
2. The Standards and Certification Criteria Final Rule is the initial approach to adopting standards, imple-
menting specifications, and providing certification criteria to enhance the interoperability, functionality,
utility, and security of HIT and to support its meaningful use.
3. The Incentive Program for Electronic Health Records was issued by CMS to provide a financial incen-
tive to eligible professionals, eligible and critical access hospitals, and Medicare Advantage Organiza-
tions that are “meaningful users” of EHRs.
a. ARRA 2009 specified three main components for “Meaningful Use”:
i. Use of certified EHRs in a meaningful manner (i.e., e-Prescribing)
ii. Use of certified EHR technology for electronic exchange of health information to improve
quality of health care
iii. Use of certified EHR technology to submit clinical quality and other measures
b. Incentive payments began in fiscal year 2011 and will gradually decrease until fiscal year 2015,
when penalties are put into effect.
B. The Patient Protection and Affordable Care Act of 2010 contains several provisions, ranging from
protecting consumers to improving health care quality and lowering costs to increasing access to care. As
the law translates into regulation, unique opportunities exist for pharmacists to become engaged.
1. Funding opportunities will be available for pharmacists to demonstrate their contributions as providers
of medication therapy management.
2. The patient-centered medical home model emphasizes primary care as a central role in managing the
chronic conditions of patients using a team-based care approach.
3. ACOs are a set of providers associated with a defined population of patients accountable for the quality
and cost of care delivered to that population.
4. Independence at Home Demonstration Program promotes the interdisciplinary collaboration of clini-
cians to provide home-based medical care for Medicare beneficiaries.
2-292
REFERENCES
The Food And Drug Administration and 2. Department of Veterans Affairs Investigational
The Prescription Drug Approval Process Drugs and Supplies Handbook. Available at www1.
1. FDA Web site. Available at www.fda.gov. Ac- va.gov/vhapublications/ViewPublication.asp?pub_
cessed January 28, 2012. ID=1333. Accessed January 28, 2012.
2. FDA Web site: How Is FDA Organized? Available 3. National Cancer Institute Clinical Trial Informa-
at www.fda.gov/AboutFDA/Transparency/Basics/ tion. Available at http://www.cancer.gov/clinical-
ucm194884.htm. Accessed January 28, 2012. trials/. Accessed January 28, 2012.
3. The Past, Present, and Future of FDA Human Drug 4. University of Pittsburgh Cancer Institute Investi-
Regulation. Available at www.fda.gov/Training/ gational Drug Service. Available at Comparative
ForHealthProfessionals/ucm209538.htm. Accessed Effectiveness Research (CER): www.upci.upmc.
January 28, 2012. edu/ids/index.cfm. Accessed January 28, 2012.
4. Presidential Actions, Executive Orders. Available at 5. Brigham and Women’s Hospital Investigational
www.whitehouse.gov/briefing-room/presidential- Drug Service. Available at www.brighamandwom-
actions/executive-orders. Accessed January 28, 2012. ens.org/research/CCI/IDS.aspx. Accessed January
5. FDA REMS. Available at www.fda.gov/down- 28, 2012.
loads/Drugs/GuidanceComplianceRegulatoryIn- 6. Seattle Children’s Hospital Investigational Drug
formation/Guidances/UCM184128.pdf. Accessed Service. Available at www.seattlechildrens.org/re-
January 28, 2012. search/cores/ids/. Accessed January 28, 2012.
6. Clinical Trials. Available at http://clinicaltrials.gov.
Accessed January 28, 2012. The Joint Commission, National Committee For
7. National Cancer Institute Clinical Trial Informa- Quality Assurance, National Quality Forum, And
tion. Available at www.cancer.gov/clinicaltrials/. Agency For Healthcare Research And Quality
Accessed January 28, 2012. 1. Chassin MR, Loeb JM, Schmaltz SP, Wachter RM.
8. Generic Pharmaceutical Association. Available at Accountability measures – using measurement
www.gphaonline.org/about-gpha/about-generics/ to promote quality improvement. N Engl J Med
facts. Accessed January 28, 2012. 2010;363:683–8.
2. The Joint Commission. Available at www.joint-
Institutional Review Board Implications commission.org/. Accessed January 28, 2012.
For Clinical Practice And Research 3. Joint Commission Center for Transforming Health-
1. Title 45 Code of Federal Regulations Part 46. Avail- care Targeted Solutions Tool. Available at www.
able at http://ohsr.od.nih.gov/guidelines/45cfr46. centerfortransforminghealthcare.org. Accessed Jan-
html. Accessed January 28, 2012. uary 28, 2012.
2. National Institute on Aging Clinical Study Inves- 4. The National Committee for Quality Assurance.
tigator’s Toolbox. Available at http://www.nia.nih. Available at www.ncqa.org/. Accessed January 28,
gov/research/dgcg/clinical-research-study-investi- 2012.
gators-toolbox. Accessed January 28, 2012. 5. The National Quality Forum. Available at www.
qualityforum.org. Accessed January 28, 2012.
Investigational Drug Service 6. The Agency for Healthcare Research and Quality.
1. American Society of Health-System Pharmacists Available at www.ahrq.gov. Accessed January 28,
Policy Position: On Institutional Review Boards 2012.
and Investigational Use of Drugs. Available at 7. Effective Health Care Program, AHRQ. Available
www.ashp.org/DocLibrary/BestPractices/Re- at http://effectivehealthcare.ahrq.gov/. Accessed
searchPositions.aspx. Accessed January 28, 2012. January 28, 2012.
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8. Pharmacy Quality Alliance. Available at www.

PQAAlliance.org. Accessed January 28, 2012.
Legislative Activity Into Regulatory Policy

1. The Office of the National Coordinator for Health
Information Technology. Available at http://heal-
thit.hhs.gov. Accessed January 28, 2012.
2. 42 CFR Parts 412, 413, 422, et al. Medicare and
Medicaid Programs; Electronic Health Record
Incentive Program Final Rule. Available at http://
edocket.access.gpo.gov/2010/pdf/2010-17207.pdf.
Accessed January 28, 2012.
3. Lipton HL. Pharmacists and health reform: go for
it. Pharmacotherapy 2010;30:967–72.
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Policy, Practice, and Regulatory Issues

Policy, Practice, and

C. History of the Regulation of Drugs and Human Subjects’ Research

(c) Criteria for patient participation

D. Prescription Drug Approval Path

i. New Molecular Entity (1)

Table 1. Components of the NDAa

Index Nonclinical pharmacology and toxicology

5. Phase IV drug trial

Table 2. Criteria for Medications to be Pharmaceutical Equivalents

2. Regulated by the Center for Devices and Radiological Health (CDRH)

G. Risk Evaluation and Mitigation Strategies

I. Critical Path Initiative

Table 4. U.S. Food and Drug Administration’s Critical Path Initiative

D. Human Subjects’ Training

E. Research Exempt from IRB Requirements

Template for Combined Informed Consent and HIPAA Authorization Form

Subject CONSENT to Participate in Research

AUTHORIZATION to Use and/or Disclose Identifiable Health information for Research

Title of the Study: Title of Research Protocol

Mailing Address: Provide PI contact mailing address

A. WHAT IS THE PURPOSE OF THIS STUDY?

Provide a clear explanation of the purpose of the research

B. WHAT WILL MY PARTICIPATION INVOLVE?

C. ARE THERE ANY BENEFITS TO ME?

D. WILL I BE PAID FOR MY PARTICIPATION?

Describe compensation for participating in this study.

E. ARE THERE ANY SIDE EFFECTS OR RISKS TO ME?

G. IS MY PERMISSION VOLUNTARY AND MAY I CHANGE MY MIND?

H. HOW LONG WILL MY PERMISSION TO USE MY HEALTH INFORMATION LAST?

Include name of PI and PI contact mailing address

I. WHO SHOULD I CONTACT IF I HAVE QUESTIONS?

AGREEMENT TO PARTICIPATE IN THIS STUDY

PERMISSION TO USE AND/OR DISCLOSE MY HEALTH INFORMATION

Name of Participant (please print):________________________________

YOU WILL RECEIVE A COPY OF THIS FORM AFTER SIGNING IT.

Signature of participant: ___________________________________________________ Date: __________

Signature of person obtaining consent and authorization:_______________________ Date: __________

III. INVESTIGATIONAL DRUG SERVICE (IDS)

(4) β-Blocker at discharge

(d) Comprehensive diabetes care

E. The Agency for Healthcare Research and Quality

b. Consumer Assessment of Healthcare Providers and Systems (CAHPS)

V. LEGISLATIVE ACTIVITY INTO REGULATORY POLICY

8. Pharmacy Quality Alliance. Available at www.

Legislative Activity Into Regulatory Policy

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Signature of participant: _________________________________________ Date:

Signature of person obtaining consent and authorization:_____________ Date: