GCP E6 Revision 3 AcademyGCP
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ICH GCP E6 (R3) Good Clinical Practice revision 3 Draft copy
Appendices
Appendix B. Clinical trial protocol and protocol amendment(s)
Appendix B.
B.1 General information
B.2 Background information
B.3 Trial objectives and purpose
B.4 Trial design
B.5 Selection of participants
B.6 Discontinuation of trial intervention and participant withdrawal from trial
B.7 Treatment and interventions for participants
B.8 Assessment of efficacy
B.9 Assessment of safety
B.10 Statistical considerations
B.11 Direct access to source records
B.12 Quality control and quality assurance
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