21 U.S. Code of Federal Regulations Flashcards
Parts 11, 50, 56, 312, 812 (10 cards)
What does 21 CFR Part 11 cover?
Electronic records and electronic signatures in research. Ensures data integrity, security, and authenticity.
- Systems must have controls to prevent unauthorized access.
- Audit trails must document all data changes.
- Electronic signatures must be unique, verifiable, and tied to the person responsible.
What does 21 CFR Part 50 cover?
Protection of human subjects in research, including requirements for informed consent.
- Consent must be documented in writing.
- Participants must understand the purpose, risks, and their right to withdraw.
- Special protections are required for vulnerable populations (e.g., children, prisoners, pregnant women).
What does 21 CFR Part 56 cover?
Institutional Review Boards (IRBs) — requirements for the structure, responsibilities, and operation of IRBs to protect human subjects.
- IRBs must review research protocols before approval.
- IRBs must ensure risks are minimized and informed consent is obtained.
- IRBs must include at least one non-affiliated member and one member with scientific expertise.
What does 21 CFR Part 312 cover?
Investigational New Drug (IND) applications — regulations for drug development and testing in clinical trials.
- Sponsors must submit preclinical data to support safety before human trials.
- Ongoing safety reporting is required throughout the trial.
- Participants must be informed of potential risks and must provide consent.
What does 21 CFR Part 812 cover?
Investigational Device Exemptions (IDE) — rules for the development and testing of medical devices in clinical trials.
- Devices must undergo safety testing before clinical use.
- Investigators must follow strict reporting guidelines to protect participants.
- Data must be collected to demonstrate the device’s safety and efficacy.
What is the purpose of 21 CFR regulations in clinical research?
To protect human subjects, ensure data integrity, and uphold ethical standards in drug and device development.
- Ensures research follows Good Clinical Practice (GCP) guidelines.
What is informed consent according to 21 CFR Part 50?
A process where participants are fully informed about the study’s purpose, risks, benefits, and their rights before agreeing to participate.
- Consent must be obtained without coercion or pressure.
- Participants must receive a copy of the signed consent form.
What is the role of an IRB under 21 CFR Part 56?
To review and approve research protocols, ensuring participant safety and ethical conduct throughout the study.
- IRBs must conduct continuing review of approved studies.
- IRBs can suspend or terminate studies that violate safety standards.
What is required for electronic records under 21 CFR Part 11?
- Secure system controls to prevent tampering or unauthorized access.
- Accurate audit trails must log all data changes.
- Electronic signatures must include identity verification and be linked to the signer’s actions.
Why are IND and IDE regulations important?
They ensure that new drugs and devices are tested safely and ethically before they are approved for public use.
- IND applications ensure new drugs undergo thorough safety evaluation.
- IDE applications ensure medical devices are assessed for risk and benefit before being marketed.
