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 5, 26.06.2024 |
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 |