Standard Operating Procedure 2 (Protocol Review) version 4.2
Form
2(A) 2022 Review Checklist Download
2(B) 2022 Application Form Download
2(C) 2022 Study Protocol Assessment Form Download
2(D) 2022 Informed Consent Assessment Form Download
2(E) 2022 Site Resources Checklist for Clinical Trials Outside FEU-NRMF Medical Center by FEU-NRMF Personnel Download
2(F) 2022 Site Resources Checklist for Clinical Trials Outside FEU-NRMF Medical Center by Non-FEU-NRMF Personnel Download
2(G) 2022 Meeting Agenda Download
2(H) 2022 Review of Resubmitted Protocol Form Download
2(I) 2022 Confidentiality Agreement for Guests and Observers Download
2(J) 2022 Transmittal Letter Download
2(K) 2022 Acknowledgement Letter Download
2(L) 2022 Approval Letter to the Study Protocol Download
2(M) 2022 Notification of Ethics Review Exemption Download
2(N) 2022 Request to Waive Written and Verbal Informed Consent Download
2(O) 2022 Disapproval Letter to the Study Protocol Download
2(P) 2022 Checklist for Exemption from Ethical Review Download
2(Q) 2022 Decision Letter on Appeal Download
Standard Operating Procedure 3 (Post Approval Review) version 4.2
Form
SOP 3 VER 4.2 Download
SOP 3 - FORMS Download
3(A) 2022 Study Protocol Amendment Submission Download
3(B) 2022 Continuing Review Form Download
3(C) 2022 Final Report Form Download
3(D) 2022 Study Non-compliance Report Download
3(E) 2022 Early Study Termination Form Download