Brief Title of SOP R&D Ref No. Version Number and Date
Management of SOPs Version 5, 31.01.2018
Version Control of Trial Documents RD GCP SOP 01 Version 3, 28.01.2021
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 4, 01.11.2019
Sponsorship RD GCP SOP 05 Version 5, 18.02.2021
Informed Consent RD GCP SOP 06 Version 3, 27.02.2019
Safety Reporting RD GCP SOP 07 Version 11,18.03.2019
Amendments RD GCP SOP 08 Version 5, 09.12.2021
Urgent Safety Measures RD GCP SOP 09 Version 3, 19.02.2020
Annual Reporting RD GCP SOP 10 Version 4, 19.03.2021
Trial Oversight Committee RD GCP SOP 11 Version 2, 04.04.2016
End of Trial RD GCP SOP 12 Version 4, 16.05.2019
Data Management RD GCP SOP 13 Version 5, 18.02.2019
Archiving Procedure RD GCP SOP 14 Version 6, 09.02.2021
GCP Monitoring RD GCP SOP 15 Version 3, 10.12.2018
Serious Breach Procedure RD GCP SOP 17 Version 2, 26.01.2015
Site Initiation of Multi-Centre Trials RD GCP SOP 18 Version 5, 08.06.2015
Vendor Selection, Assessment, Contracting and Oversight RD GCP SOP 19 Version 1, 14.02.2021
Statistical Analysis of Clinical Trial Data RD GCP SOP 20 Version 1, 03.11.2021