Brief Title of SOP R&D Ref No. Version Number and Date
Management of SOPs Version 6, 14.12.2022
Version Control of Trial Documents RD GCP SOP 01 Version 4, 14.12.2022
Protocol Design RD GCP SOP 02 Version 3, 17.02.2021
CRF Format and Design RD GCP SOP 03 Version 3, 18.02.2021
Trial Setup, Conduct and Trial Master File RD GCP SOP 04 Version 7, 19.04.2023
Sponsorship RD GCP SOP 05 Version 6, 21.12.2022
Informed Consent RD GCP SOP 06 Version 4, 21.12.2022
Safety Reporting RD GCP SOP 07 Version 12, 30.12.2022
Amendments RD GCP SOP 08 Version 5, 09.11.2021
Urgent Safety Measures RD GCP SOP 09 Version 4, 03.01.2023
Annual Reporting RD GCP SOP 10 Version 4, 19.03.2021
Trial Oversight Committee RD GCP SOP 11 Version 3, 17.01.2022
End of Trial RD GCP SOP 12 Version 5, 03.01.2023
Data Management RD GCP SOP 13 Version 6, 17.08.2022
Archiving RD GCP SOP 14 Version 7, 08.04.2024
GCP Monitoring RD GCP SOP 15 Version 3, 14.06.2022
Production of a Randomisation Schedule for Randomised Controlled Trials (RCTs) RD GCP SOP 16 Version 1, 24.05.2022
Serious Breach Procedure RD GCP SOP 17 Version 3, 03.01.2023
Site Initiation of Multi-Centre Trials RD GCP SOP 18 Version 6, 31.03.2022
Vendor Assessment RD GCP SOP 19 Version 2, 11.04.2024
Statistical Analysis of Clinical Trial Data RD GCP SOP 20 Version 1, 03.11.2021
Submissions RD GCP SOP 21 Version 1, 24.03.2023