Table 3.
Comparison of original and repeated questions (n = 53)
| ICH domain | Original % correct | Repeat % correct | P -value |
|---|---|---|---|
| ICH Intro | 83.0 | 94.3 | 0.0339 |
| ICH Intro | 77.4 | 79.2 | 0.5637 |
| ICH Intro | 86.8 | 90.6 | 0.5291 |
| Belmont Report | 73.6 | 66.0 | 0.3458 |
| Belmont Report | 92.5 | 92.5 | 1.00 |
| ICH Section 2 (Principles of GCP) | 86.8 | 88.7 | 0.7630 |
| ICH Section 2 (Principles of GCP) | 66.0 | 84.9 | 0.0047 |
| ICH Section 2 (Principles of GCP) | 62.3 | 62.3 | 1.00 |
| ICH Section 3 (IRB) | 94.3 | 92.5 | 0.6457 |
| ICH Section 3 (IRB) | 88.7 | 81.1 | 0.1573 |
| ICH Section 4 (Investigator) | 88.7 | 75.5 | 0.1088 |
| ICH Section 4 (Investigator) | 52.8 | 74.4 | 0.0046 |
| ICH Section 5 (Sponsor) | 100.0 | 98.1 | – |
| ICH Section 5 (Sponsor) | 66.0 | 71.7 | 0.3657 |
| ICH Section 5 (Sponsor) | 90.6 | 94.3 | 0.3173 |
| ICH Section 5 (Sponsor) | 71.7 | 69.8 | 0.7815 |
| ICH Section 5 (Sponsor) | 7.5 | 32.1 | 0.0008 |
| ICH Section 5 (Sponsor) | 92.5 | 92.5 | 1.00 |
| ICH Section 6 (Protocol) | 67.9 | 79.2 | 0.1088 |
| ICH Section 7 (Investigator Brochure) | 88.7 | 83.0 | 0.3173 |
| ICH Section 7 (Investigator Brochure) | 84.9 | 77.4 | 0.2059 |
| ICH Section 7 (Investigator Brochure) | 86.8 | 88.7 | 0.7630 |
| ICH Section 8 (Essential Documents) | 98.1 | 96.2 | 0.5637 |
| ICH Section 8 (Essential Documents) | 66.0 | 83.0 | 0.0126 |
| ICH Section 8 (Essential Documents) | 90.6 | 90.6 | 1.0 |
The data in Table 3 are from the item analyses of the full set of questions 1–100, with 53 participants completing all 100 items. GCP, Good clinical practice guidelines; ICH, International Conference on Harmonization; IRB, Institutional Review Board.