Standard Operating Procedure 3 (Post Approval Review) version 4.2
Form
3(F) 2022 Queries or Complaints Download
3(G) 2022 Serious Adverse Events Report Download
3(H) 2022 SAE Report Summary Download
3(I) 2022 Site Visit Report Form Download
3(J) 2022 Reminder Letter for Continuing Review Final Report Download
3(K) 2022 Notice of Site Visit Download
3(L) 2022 Progress Report Form Download
Standard Operating Procedure 4 (Documentation and Archiving) version 4.2
Form
SOP 4 VER 4.2 Download
SOP 4 - FORMS Download
4(A) 2022 Format of the Minutes of the Meeting Download
4(A) 2022 Format of the Minutes of the Meeting Download
4(C) 2022 Letter for Clarificatory Interview Download
4(D) 2022 Approval Letter to the Study Protocol Amendment Download
4(E) 2022 Notification Letter (Info or Further Act) Progress Report, Continuing Review, Final Report, Deviation, AE, Site Visit Download
4(F) 2022 Archiving Notification Download
4(G) 2022 Borrowers Log Download
4(H) 2022 Confidentiality Agreement for Non-members Download
4(I) 2022 Log of Request for Copies of Documents Download
4(J) 2022 Certification of Board Action Download
4(K) 2022 Notification Letter (Uphold approval) to Continuing Review Application, Deviation, AE, Site Visit Download
4(L) 2022 Submissions Log Download
4(M) 2022 Outgoing Communications Log Download
Standard Operating Procedure 5 (Preparing Standard Operating Procedures) version 4.2
Form
SOP 5 VER 4.2 Download
SOP 5 - FORMS Download