21 CFR Part 56 Flashcards
What does 21 CFR Part 56 cover?
Institutional Review Boards
Each IRB should have at least how many members?
5
Each IRB shall include:
1 member whose primary concerns are in the scientific area and 1 whose primary concerns are in nonscientific areas, and 1 who is not otherwise affiliated with the institution.
Criteria for IRB approval
- Risks to subjects are minimized. 2. Risks to subjects are reasonable in relation to anticipated benefits. 3. Selection of subjects is equitable. 4. informed consent from each subject. 5. informed consent should be documented. 6. research plan makes adequate provision for monitoring the data collected. 7. adequate provisions to protect the privacy of subjects and to maintain confidentiality of subjects.
test article
any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the act or under sections 351 or 354-360F of the public health service act.
A research permit under section 505(i) of the act is usually known as
investigational New Drug (IND) application
A research permit under section 520(g) of the act is usually known as
investigational device exemption (IDE)
When must an IRB register?
Each IRB must submit an initial registration and must renew every 3 years. IRB registration become effective after review and acceptance by HHS.
Where can an IRB register?
Either electronically or in writing to the Office of Good Clinical Practice, Office of Special medical programs, Food and drug administration, silver spring, MD.
How does an IRB revise its registration information?
must submit changes within 90 days. 30 days if disbanning, otherwise at time of registration renewal.
What is 21 CFR 56 Subpart D
Records and Reports
What is 21 CFR 56 Subpart E
Administrative Actions for NonCompliance
What is 21 CFR 56 Subpart B
Organization and personnel
What is 21 CFR 56 Subpart C
IRB Functions and Operations
What is 21 CFR 56 Subpart B 106
Registration
What is 21 CFR 56 Subpart B 107
IRB membership
What is 21 CFR 56 Subpart C 108
IRB functions and operations
What is 21 CFR 56 Subpart C 109
IRB review of research
What is 21 CFR 56 Subpart C 110
Expedited review procedures for certain kinds of research involving no more than minial risk, and for minor changes in approved research
What is 21 CFR 56 Subpart C 111
Criteria for IRB approval of research
What is 21 CFR 56 Subpart C 112
Review by institution
What is 21 CFR 56 Subpart C 113
Suspension or termination of IRB approval of research
What is 21 CFR 56 Subpart C 114
Cooperative Research
What is 21 CFR 56 Subpart D 115
IRB records
What is 21 CFR 56 Subpart E 120
Lesser administrative actions
What is 21 CFR 56 Subpart E 121
Disqualification of an IRB or an institution
What is 21 CFR 56 Subpart E 122
Public disclosure of information regarding revocation
What is 21 CFR 56 Subpart E 123
Reinstatement of an IRB or an institution
What is 21 CFR 56 Subpart E 124
Actions alternative or additional disqualification
