SOCRA Cheat Sheet 2026

The 30 highest-yield SOCRA facts, distilled from real exam questions. Print it, save it as a PDF, or study it here — free, no sign-up.

1. Which principle underpins the requirement that researchers must report unanticipated problems involving risks to subjects or others to the IRB? → Beneficence and non-maleficence — protecting participants from harm
2. What is the purpose of a monitoring report? → Document findings, issues, and action items from each monitoring visit
3. According to GCP, how long must drug accountability records be retained after trial completion? → 2 years after marketing approval or end of IND, whichever is later
4. The Declaration of Helsinki states that research involving human subjects may only proceed if: → The importance of the objective outweighs the risks and burdens to research subjects
5. What if IP is damaged during shipment? → Document damage, quarantine, notify sponsor immediately, do not use pending instructions
6. Which condition must be met for an IRB to approve a waiver of informed consent for research under 45 CFR 46.116(f)? → The research could not practicably be carried out without the waiver
7. What is the FDA's BIMO program? → A comprehensive inspection program covering sponsors, monitors, IRBs, and investigators
8. The Nuremberg Code was developed primarily in response to which historical event? → Nazi medical experiments conducted on prisoners during World War II
9. According to 21 CFR 312, an investigator is required to report a serious adverse event (SAE) to the sponsor: → Immediately, regardless of whether it is considered drug-related.
10. When FDA conducts a Bioresearch Monitoring (BIMO) inspection of a clinical investigator site, which records are investigators required to make available? → All records, including case histories, informed consent forms, and financial records
11. A CRA discovers that a CRF entry differs from the source document. What is the correct first step? → Issue a data query to the site to clarify the discrepancy
12. According to ICH E6, who is primarily responsible for determining causality of an adverse event to the investigational product at the site level? → The investigator
13. Which level of risk is the maximum allowed for research to qualify for expedited IRB review? → Minimal risk
14. What does GCP stand for in the context of clinical research? → Good Clinical Practice
15. In the context of adverse event reporting, an event is considered 'unexpected' when: → Its nature, severity, or frequency is not consistent with the Investigator's Brochure
16. What is 21CFR50 Subpart D? → Additional Safeguards for Children in Clinical Investigations
17. An investigator wants to waive the requirement for signed informed consent documentation. Which regulation governs this waiver? → 45 CFR 46.117(c)
18. What is the Declaration of Helsinki? → A set of ethical principles for medical research involving human subjects
19. Which laboratory document must be on file at an investigative site to validate clinical laboratory test results? → Normal reference ranges and lab certification/accreditation documents
20. Which of the following best defines 'source data' according to ICH E6 GCP? → Original records and certified copies of original records of clinical findings
21. Under FDA regulations, how long must clinical trial records be retained? → 2 years after the last approval of a marketing application
22. What are investigator consent obligations per ICH E6? → Must personally ensure adequate consent is freely given before and throughout the study
23. Which element is NOT required to be included in an ICH GCP-compliant informed consent document? → Name of the sponsor's Chief Medical Officer
24. What is the primary function of a Data Safety Monitoring Board (DSMB)? → To independently monitor participant safety and study data integrity during a trial
25. The Code of Federal Regulations that applies to Electronic Records; Electronic Signatures is.. → 21CFR11
26. Which of the following is NOT a required element for full board IRB review approval? → The sponsor has approved the protocol
27. Which of the following is NOT a required element on the label of an investigational product according to 21 CFR 312.6? → The name and address of the Principal Investigator.
28. A sponsor is required by 21 CFR 312.32 to submit an IND safety report to the FDA and all participating investigators for which type of event? → A suspected adverse reaction that is both serious and unexpected.
29. Under 21 CFR Part 11, which of the following is required for electronic records to be considered trustworthy? → Systems must include audit trails, access controls, and validated software
30. Which of the following adverse events would be classified as 'medically significant' and therefore serious, even without death or hospitalization? → Development of drug dependence or a potentially carcinogenic finding