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Events


Upcoming Event(s)
  Training on Principles of Good Clinical Practice
               and Research Ethics for Investigators and Ethics Committee Members
 
  The 2007 NIH/UPM-FERCAP Ethics Training-Workshop Series

      
Forms associated to the FERCAP SOPs
  Form Name Form Code Process Name Ref. SOP# SOP Title
1 Contents of a Submission Package FF 01-007 1. Initial check application documents FE 007 Management of Protocol Submission
2 Initial Review Application Form FF 01-010 2. Check for completeness of information FE 010 Initial Review of Protocol Application
3 Document Receipt Form FF 02-007 3. Receiving Protocol package FE 007 Management of Protocol Submission
4 Communication Form FF 01-019 4. Internal and external communication FE 019 Communication Records
5 Assessment Form FF 01-008 5. Review FE 008 Use of Assessment Form
6 Format of Agenda FF 01-028 6. Board Meeting FE 028 Preparation of Meeting Agenda and Minutes
7 Decision of the Review FF 02-008 7. Decision FE 028 Application Submission Form
8 Meeting Minute Form FF 02-028 8. Writing Minute FE 028 Preparation of Meeting Agenda and Minutes
9 Decision Notification FF 03-028 9. Notification FE 028 Preparation of Meeting Agenda and Minutes
10 Resubmission Report Form FF 01-011 10. Resubmission FE 011 Review of Resubmitted Protocol
11 rotocol Amendment Submission Form FF 01-012 11. Amendment FE 012 Review of Protocol Amendment
12 Continuing Review Application Form FF 01-013 12. Continuing Review FE 013 Management of Continuing Review
13 SAE Report Form FF 01-018 13. Review SAE FE 018 Review of SAE Report
14 Summary of Unexpected AE FF 02-018   FE 018 Review of SAE Report
15 Checklist for a Monitoring Visit FF 01-020 14. Monitoring study FE 020 Site Monitoring Visits
16 Study Termination Memorandum FF 01-014 15. Study Termination FE 014 Management of Protocol Termination
17 Final Report Form FF 01-015 16. Final Report FE 015 Review of Final Report
18 Complaint Record FF 01-017 17. Recording subject complaint FE 017 Responses to Volunteer/ Patient Requests Regarding Rights
19 Log of Document Requests FF 01-024 18. Maintaining confidentiality FE 024 Maintaining Confidentiality of Documents
20 Checklist of Audit and Inspection FF 01-026 19. Self- and external auditing FE 026 Auditing and Inspection of IEC/IRB
21 List of SOPs FF 01-001 20. Collection of SOPs FE 001 Preparation of SOPs
22 Approval Cover Page FF 02-001 21. SOP format FE 001 Preparation of SOPs
23 Table of Content FF 03-001   FE 001 Preparation of SOPs
24 Content of Main Context FE 04-001   FE 001 Preparation of SOPs
25 Log of SOP Recipients FF 05-001   FE 001 Preparation of SOPs
26 Request for SOP Revision FF 06-002 2. Control distribution of SOP documents FE 002 Distribution of SOPs and Guidelines
27 List of Guidelines FF 01-002 23. Control distribution of Guidelines FE 002 Distribution of SOPs and Guidelines
28 Log of Guidelines FF 02-002   FE 002 Distribution of SOPs and Guidelines
29 Confidentiality / Conflict of Interest (COI)Agreement for members FF 01-004 23. Agreement on Confidentiality and COI FE 004 Confidentiality / Conflict of Interest Agreement
30 Confidentiality / Agreement for Guest attendee FF 02-004   FE 004 Confidentiality / Conflict of Interest Agreement
31 Confidentiality / Conflict of Interest Agreement for non-member attending Board meeting FF 03-004   FE 004 Confidentiality / Conflict of Interest Agreement
32 Confidentiality / Conflict of Interest Agreement for non-member requesting documents FF 03-006   FE 006 Selection of Independent Consultant
33 Training Record Form FF 01-005 24. Record training history FE 005 Training Personnel and Ethics Committee Members
34 Professional Service Agreement FE 01-006 25. Agreement on service FE 006 Selection of Independent Consultant
35 Consultant Report Form FE 02-006 26. Report the consultative service FE 006 Selection of Independent Consultant
36 Deviation/Non-Compliance/Violation Record FE 01-021 27. Record of protocol deviation / GCP non-compliance / Violation FE 021 Deviation/Non-Compliance/Violation

 

Last Update:January 5, 2014.
"Promoting Ethics and Science in Clinical Trials"
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