GCP SOPs for HEY-Sponsored CTIMPS

Brief Title of SOP R&D Ref No. Version Number and Date
Management of SOPs Version 5, 31.01.18
Version Control of Trial Documents RD GCP SOP 01 Version 2, 18.02.15
Protocol Design RD GCP SOP 02 Version 2, 23.11.15
CRF Format and Design RD GCP SOP 03 Version 2, 01.02.18
Trial Setup, Conduct and Trial Master File RD GCP SOP 04 Version 2, 02.02.15
Request for Sponsorship and R&D Approval RD GCP SOP 05 Version 3, 07.02.18
Informed Consent Procedure RD GCP SOP 06 Version 2, 19.01.15
Safety Reporting RD GCP SOP 07 Version 10, 01.11.18
Amendments RD GCP SOP 08 Version 3, 12.11.14
Annual Progress and Safety Reporting RD GCP SOP 10 Version 2, 31.03.16
Trial Oversight Committee RD GCP SOP 11 Version 2, 04.04.16
End of Trial RD GCP SOP 12 Version 3, 28.06.16
Data Management RD GCP SOP 13 Version 4, 05.10.15
Archiving Procedure RD GCP SOP 14 Version 4, 26.01.15
GCP Monitoring RD GCP SOP 15 Version 2, 01.02.18
Serious Breach Procedure RD GCP SOP 17 Version 2, 26.01.15
Site Initiation of Multi-Centre Trials RD GCP SOP 18 Version 5, 08.06.15
Auditing Research at HEY RD GCP SOP 20 Version 1, 27.02.12