GCP E6 Revision 3 AcademyGCP
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ICH GCP E6 (R3) Good Clinical Practice revision 3 Draft copy
III Anex 1
2. Investigator
2.1 Qualifications and training
2.2 Resources copy
2.3 Responsibilities
2.4 Communication with IRB/IEC
2.5 Compliance with Protocol
2.6 Premature termination or suspension of a trial
2.7 Participant medical care and safety reporting
2.8 Informed consent of trial participants
2.9 End of participation in a clinical trial
2.10 Investigational product management
2.11 Randomisation procedures and unblinding
2.12 Records
2.13 Reports
Published with Nuclino