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 5, 02.03.2022 |
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 3, 17.01.2022 |
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 |