Relevant CFRs and ICH Guidelines

Question 1

Where can you find guidelines regarding Good Clinical Practices (GCP)?

Answer 1

ICH E6 (R2)

Question 2

Where can you find guidance regarding Essential Documents?

Answer 2

ICH E6 (R2); Section 8

Question 3

Which CFR details the Common Rule?

Answer 3

45 CFR 46 (HHS); Subpart A

Note: 45 CFR 46 Outlines ethical principles and guidelines for ensuring the rights and welfare of human subjects involved in research.

Note: Subpart A (The Common Rule) is a robust set of protections for research subjects, general requirements for informed consent, and general requirements for IRB review.

Question 4

What are the subparts of 45 CFR 46?

Answer 4

Subpart A: (Common Rule) Basic HHS policy for protection of human research subjects

Subpart B: Additional protections for pregnant women, fetuses, and neonates

Subpart C: Additional protections pertaining to biomedical and behavioral research involving prisoners

Subpart D: Additional protections for children

Subpart E: Registration of Institutional Review Boards (IRBs)

Cats (common)
Prefer (pregnant)
Playing (prisoners)
Chess (children)
Inside (IRB)

Question 5

What is detailed in 21 CFR 11?

Answer 5

Electronic record and electronic signatures

Question 6

What is detailed in 21 CFR 50?

Answer 6

Protection of human subjects (mirrors 45 CFR 46 Common Rule)

> Subpart A: General provisions for investigations of drugs, medical devices, biological products, dietary supplements, and electronics

> Subpart B: Informed consent of human subjects

> Subpart C: Reserved

> Subpart D: Additional safeguards for children

Question 7

What is detailed in 21 CFR 50.24?

Answer 7

Exception from informed consent requirements for emergency research

Question 8

What is detailed in 21 CFR 56?

Answer 8

General standards for the composition, operations, and responsibilities of an Institutional Review Boards (IRBs)

Subpart A: General provisions
Subpart B: Organizational and Personnel
Subpart C: IRB Functions and Operations
Subpart D: Records and Reports
Subpart E: Administrative actions for noncompliance

Question 9

What is detailed in 21 CFR Subchapter F?

Answer 9

Biologics

Question 10

What is detailed in 21 CFR 312?

Answer 10

IND Application
(Submitted before the initiation of a clinical trial)

Question 11

What are the general responsibilities of the sponsor outlined in 21 CFR 312.50 (IND) and 21 CFR 812.40 (IDE)?

Answer 11

> Selection of qualified investigators and providing them with all relevant and pertinent information.

> appropriate transfer of responsibilities to a CRO.

> ensuring the investigation is conducted in accordance with the plan/protocols contained in the IND. Also maintaining an effective IND.

> ensure proper monitoring of the investigation.

> ensure that all investigators are informed of significant new adverse effects or risks with respect to the drug.

Question 12

What is detailed in 21 CFR 314?

Answer 12

New Drug Application (NDA)
(Submitted at the end of a clinical trial for premarket approval of a new drug)

Question 13

What is detailed in 21 CFR 803?

Answer 13

Medical device reporting

Question 14

What is detailed in 21 CFR 812?

Answer 14

Investigational Device Exemptions (IDE)

> Subpart A: General provisions
Subpart B: Application and administrative action
Subpart C: Responsibilities of the sponsor
Subpart D: IRB review and approval
Subpart E: Responsibilities of investigators
Subpart F: Reserved
Subpart G: Records and reports

Question 15

What is detailed in 21 CFR 814?

Answer 15

Premarket approval of medical devices

Question 16

What is detailed in 21 CFR 820?

Answer 16

Quality System Regulations (counterpart to GMP requirements)

Question 17

What is detailed in 21 CFR 860?

Answer 17

Medical device classification procedures