GCP E6 Revision 3 AcademyGCP
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ICH GCP E6 (R3) Good Clinical Practice revision 3 Draft copy
III Anex 1
3. Sponsor
Sponsor
3.1 Trial design
3.2 Resources
3.3 Allocation of activitie
3.4 Qualification and training
3.3 Allocation of activitie copy
3.5 Financing
3.6 Agreements
3.7 Investigator selection
3.8 Communication with IRB/IEC and regulatory authority(ies)
3.9 Sponsor oversight
3.10 Quality management
3.11 Quality assurance and quality control
3.12 Noncompliance
3.13 Safety assessment and reporting
3.14 Insurance/indemnification/compensation to participants and investigators
3.15 Investigational Product(s)
3.16 Data and records
3.17 Reports
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