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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

       Starting from November 2002 since the SOPs draft began, FERCAP had participated in 4 workshops on SOPs peer review organized by local fora in 4 countries – India, Japan, Uganda and Thailand. Some corrections were made after each workshop. These SOPs are listed below:

Development of Standard Operating Procedures for Ethics Committees
No. List of SOPs. Code Version Effective date
1 Preparation of Standard Operating Procedures FE 001 1.0 1 Aug. 2003
2 Distribution of Standard Operating Procedures and Guidelines FE 002 1.0 1 Aug. 2003
3 Constituting an IEC/IRB FE 003 1.0 1 Aug. 2003
4 Confidentiality / Conflict of Interest Agreements FE 004 1.0 1 Aug. 2003
5 Training Personnel and IEC/IRB Members FE 005 1.0 1 Aug. 2003
6 Selection of Independent Consultants FE 006 1.0 1 Aug. 2003
7 Management of Protocol Submission FE 007 1.0 1 Aug. 2003
8 Use of Study Assessment Form FE 008 1.0 1 Aug. 2003
9 Expedited Review FE 009 1.0 1 Aug. 2003
10 Initial Review of Application Protocol FE 010 1.0 1 Aug. 2003
11 Review of Resubmitted Protocol FE 011 1.0 1 Aug. 2003
12 Review of Protocol Amendments FE 012 1.0 1 Aug. 2003
13 Continuing Review of Study Protocol FE 013 1.0 1 Aug. 2003
14 Review of Protocol Termination FE 014 1.0 1 Aug. 2003
15 Review of Final Reports FE 015 1.0 1 Aug. 2003
16 Emergency Meeting FE 016 1.0 1 Aug. 2003
17 Response to Participants' Requests FE 017 1.0 1 Aug. 2003
18 Monitoring and Evaluation of Serious Adverse Events (SAE) Reports FE 018 1.0 1 Aug. 2003
19 Communication Records FE 019 1.0 1 Aug. 2003
20 Site Monitoring Visit FE 020 1.0 1 Aug. 2003
21 Non-Compliance/Violation Intervention FE 021 1.0 1 Aug. 2003
22 Maintenance of Active Study Files FE 022 1.0 1 Aug. 2003
23 Archive and Retrieval of Documents FE 023 1.0 1 Aug. 2003
24 Maintaining Confidentiality of IEC/IRB’s Documents FE 024 1.0 1 Aug. 2003
25 Preparation of Guidelines FE 025 1.0 1 Aug. 2003
26 Audit and Inspection of the IEC/IRB FE 026 1.0 1 Aug. 2003
27 Glossary of Terms and Definition FE 027 1.0 1 Aug. 2003
28 Preparation of Meeting, Agenda, Minutes and Action letters FE 028 1.0 1 Aug. 2003
29 Review of New Medical Device Studies FE 029 1.0 1 Aug. 2003


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