Table 1.
Frequency of GCP topics in questions
| Frequency of topics | ||
|---|---|---|
| Regulatory guidance document/topic | Questions 1–75 | Repeat questions 76–100 |
| Belmont Report and Declaration of Helsinki | 6 | 2 |
| ICH E6 R2 (Introduction, Section 1 and 2)/Introduction, Glossary, and GCP Principles | 10 | 6 |
| ICH E6 R2 (Section 3)/Institutional Review Board (IRB) | 7 | 2 |
| ICH E6 R2 (Section 4)/Investigator Responsibilities | 18 | 2 |
| ICH E6 R2 (Section 5) / Sponsor Responsibilities | 16 | 6 |
| ICH E6 R2 (Section 6)/Protocol and Protocol Amendments | 7 | 1 |
| ICH E6 R2 (Section 7)/Investigator Brochure | 5 | 3 |
| ICH E6 R2 (Section 8)/Essential Documents | 6 | 3 |
GCP, Good clinical practice guidelines; ICH E6 R2, International Conference on Harmonization, Efficacy Guidelines #6, Revision 2; IRB, Institutional Review Board.