Table 2.
GCP Elements Listed in Investigator Section of ICH E6.1
| GCP Element | |
|---|---|
| 1 | Investigator’s qualifications and agreements |
| 2 | Adequate resources |
| 3 | Medical care of trial subjects |
| 4 | Communication with IRB/IEC |
| 5 | Compliance with protocol |
| 6 | Investigational product(s) |
| 7 | Randomization procedures and unblinding |
| 8 | Informed consent of trial subjects |
| 9 | Records and reports |
| 10 | Progress reports |
| 11 | Safety reporting |
| 12 | Premature termination or suspension of a trial |
| 13 | Final report(s) by investigator/institution |
Abbreviations: GCP, Good Clinical Practice; IRB/IEC, institutional review board / institutional ethics committee.