Brief Title of SOP R&D Ref No. Version Number and Date
Management of SOPs V7, 24.04.2026
Version Control of Trial Documents RD GCP SOP 01 V5, 30.04.2026
Protocol Design RD GCP SOP 02 V4, 30.04.2026
CRF Format and Design RD GCP SOP 03 V5, 30.04.2026
Trial Setup, Conduct and Trial Master File RD GCP SOP 04 V8, 30.04.2026
Sponsorship RD GCP SOP 05 V7, 14.05.2026
Informed Consent RD GCP SOP 06 V5, 24.04.2026
Safety Reporting RD GCP SOP 07 V13, 23.04.2026
Amendments RD GCP SOP 08 V6, 23.04.2026
Urgent Safety Measures RD GCP SOP 09 V5, 24.04.2026
Annual Reporting RD GCP SOP 10 VV6, 24.04.2026
Trial Oversight Committee RD GCP SOP 11 V4, 24.04.2026
End of Trial RD GCP SOP 12 V6, 24.04.2026
Data Management RD GCP SOP 13 V7, 24.04.2026
Archiving RD GCP SOP 14 V8, 24.04.2026
GCP Monitoring RD GCP SOP 15 V4, 27.04.2026
Production of a Randomisation Schedule for Randomised Controlled Trials (RCTs) RD GCP SOP 16 V2, 27.04.2026
Serious Breach Procedure RD GCP SOP 17 V4, 27.04.2026
Site Initiation of Multi-Centre Trials RD GCP SOP 18 V7, 27.04.2026
Vendor Assessment RD GCP SOP 19 V3, 27.04.2026
Statistical Analysis of Clinical Trial Data RD GCP SOP 20 V2, 27.04.2026
Submissions RD GCP SOP 21 V2, 27.04.2026