AUF-IERC

AUF-IERC Work Processes

1. WORK PROCESS:APPLICATION OF INITIALSUBMISSION AND RESUBMISSION

Steps Flow Responsibility
1 Submission of letter ofintent address to the Chair (AUFFORM-SOM-143January4,2016-Rev.00) Primary Investigator
2 The investigator is provided with an application form (AUFFORM-SOM-IERC-130 January4,2016–Rev.00) Office Secretary
3 Submissionof seven copies of the package recquired by theAUF IERC to the office secretary Office Secretary
4 The protocol package is checked for completeness based on the AUF IERC checklist. Office Secretary
5 The primary investigator is informed on the status of the application. Incomplete submission is not processed and the Primary investigator is informed to resubmit lacking documents. Office Secretary
6 Complete submission is processed Office Secretary
7 A code is assigned to the packaged and it is officially recorded in a logbook and electronic data base Office Secretary
8 The chair and committee secretary is notified about the submission Office Secretary
9 The submission is classified whether it is a full committee review or expedited review and the schedule of the meeting is set Chair/Committee  Secretary

 

2. WORK PROCESS: INITIAL REVIEW PROCEDURE

Steps Flow Responsibility
1 Set the schedule of meeting four weeks after submission of required documents Chair
2 Assignment of reviewers Chair
3 Invitation of Independent Consultant Chair / Committee Secretary
4

Distribution of the notice of meeting (AUF-FORM-SOM-IERC131January4,2015,Rev.00),
submission package and assessment form AUF-FORM-SOM-IERC-133&134 January4,2016–Rev.00

Office Secretary
5 Assessment of submission package using the assessment form (AU F-Form-SOM-IERC133&134) Reviewers & Independent Consultant

 

3. WORK PROCESS:CONDUCT OF FULL COMMITTEE REVIEW MEETING

Steps Flow Responsibility
1 Call to order Chair
2 Determination of a quorum Chair
3 DeclarationofConflictofInteres Chair; AUF-IERC members & Independent Consultant
4 Signing of Conflict of Interest form(AUF-FORM-SOMIERC-128 effective January 4,2016–Rev.00) and Confidentiality agreement form (AUF-Form-SOMIERC129 effective January 4,2016–Rev.00) Chair;AUF-IERC members & Independent Consultant
5 Approval of the minutes of the previous meeting AUF-IERC members
6 Discussion of the business arising from the previous meeting  
7 Discussion of the business of the day  
8 Review of protocols for initial review  
9 Presentation of the abstract of the study Primary Investigator
10 Clarification of issues about the study AUF-IERC members and Independent Consultants
11 Primary Investigator is requested to step out Chair
12 Discussion of issues AUF-IERC members and Independent Consultants
13 Independent Consultant is requested to step out Chair
14 Deliberation AUF-IERC members
15 Recommendation are written in a form(AUF-FORM-SOM-IERC 136 effective January 4, 2016–Rev.00) AUF-IERC members
16 Decision by consensus AUF-IERC members
17 Summary of the recommendations and decision Chair
18 Submission of recommendation AUF-FORM-SOM-IERC- 18 137 effective January 4, 2016 – Rev.00 and assessment forms AUF-FORM-SOM-IERC- 133& 134 effective January 4, 2016 – Rev.00) AUF-IERC members
19 Preparation of Summary of Recommendation and Decision Committee Secretary
20 Signed approval letter Chair
21 The PI is informed of the decision within 2 weeks after the meeting Committee Secretary
22 Discussion of Post Review issues ( AUF-SOP-SOM-21 ) Chair
23 Discussion of SAE issues ( AUF-SOP-SOM-24 ) Independent Consultant for SAE
24 Report of results of expedited review Chair
25 Report of queries and complaints Chair
26 Discussion of administrative and other matters Chair

 

4. WORKPROCESS: CONDUCT OF EXPEDITED COMMITTEE REVIEW MEETING

Steps Flow Responsibility
1 Call to order Chair
2 Declaration of Conflict of Interest Chair; AUF-IERC members & Independent Consultant
3 Signing of Conflict of Interest form(AUF-FORM-SOM-IERC128 effective January 4, 2016–Rev.00) and
Confidentiality agreement form (AUF-Form-SOMIERC129 effective January 4, 2016–Rev.00)
Chair; AUF-IERC  members & Independent Consultant
4 Review of protocols for initial review Chair; AUF-IERC  members & Independent Consultant
5 Discussion of issues Chair; AUF-IERC  members & Independent Consultant
6 Independent Consultant is requested to step out Chair
7 Deliberation Chair & AUF-IERC members
8 Recommendation are written ina form(AUF-FORM-SOMIERC-136 effective January 4, 2016–Rev.00) AUF-IERC members
9 Decision by consensus AUF-IERC members
10 Summary of the recommendations and decision Chair
11 Submission of recommendation (AUF-FORM-SOM-IERC137 effective January 4,2016–Rev.00 and assessment forms AUF-FORM-SOM-IERC-133 & 134 effective January 4, 2016–Rev.00) AUF-IERC members
12 Preparation of the summary of recommendation and decision Committee Secretary
13 Inform the PI about the decision Committee Secretary
14 Include the decision in the agenda for Full Committee Meeting Chair

 

5. WORKPROCESS: ACTION ON THE PROPOSAL

Steps Flow Responsibility
1 Approval of the minutes of the meeting. Chair
2 Preparation of summary of recommendation (AUFFORM-SOM-IERC-137 January 4, 2016-Rev 00) Committee Secretary
3 Approval of the Summary of recommendation Chair
4 Preparation of the Approval form (AUF-FORMIERC-138 January 4, 2016-Rev 00) and letter of approval (AUF-FORM-SOM-143 January 4, 2016- Rev 00) Committee Secretary
5 Inform the primary investigator of the decision Chair
6 Storage of the decision document in the protocol file (SOP on Managing Active Files) ERC Staff, Member Secretary

 

6. WORK PROCESS: CONTINUING REVIEW OF PROTOCOL (REFER TO THE SOP ON FULL COMMITTEE REVIEW)

Steps Flow Responsibility
1 Call to order Chair
2 Determination of a Quorum Chair
3 Declaration of conflict of interest Chair, AUF-IERC members and independent consultants
4 Signing of Conflict of Interest form (AUF-FormSOM-IERC-128 effective January 4, 2016-Rev 00) and Confidentiality Agreement form (AUF-FormSOM-IERC-129 effective January 4, 2016-Rev 00) Chair, AUF-IERC members and independent consultants
5 Approval of the previous meeting AUF-IERC members
6 Discussion of the business arising from the previous meeting Chair
7 Discussion of the business of the day Chair
8 Discussion of Post-Review issues (AUF-SOPSOM-21) Chair
9 Discussion of SAE issues (AUF-SOP-SOM-21) Independent Consultant for SAE
10 Report of queries and complaints Chair
11 Discussion of administrative and other matters Chair
12 Meeting adjourned Chair

 

7. WORKPROCESS: SUBMISSION; ANALYSIS AND DECISION ON SAE

Steps Flow Responsibility
1 Submission of SAE report to AUF-IERC Primary investigator
2 Receipt of the SAE report Office Secretary
3 Login logbook and SAE database Office Secretary
4 Classify the SAE whether onsite or offsite Office Secretary
5 Invite the Independent Consultant and provide a copy Office Secretary
6 Analysis of data Independent consultant
7 Request for additional information Independent consultant
8 Recommendation Independent consultant
9 Presentation of SAE report to AUF-IERC members and Chair during the full committee review meeting Independent consultant
10 submission of SAE report to the Chair Independent consultant
11 Independent consultant requested to step out Chair
12 Deliberation of issues Chair & AUF-IERC members
13 Writing of recommendation Committee Secretary
14 Decision by consensus Chair
15 Recommendations and decision is summarized at the end of the meeting Chair & AUF-IERC members
16 Preparation of summary of recommendation Committee Secretary
17 Filing of documents and updating of file Office Secretary
18 Primary investigator is notified Office Secretary

 

8. WORK PROCESS: SITE VISIT

Steps Flow Responsibility
1 Selection of study site Chair
2 Communication to the Primary Investigator two weeks before the scheduled visit Committee Chair
3 Site visit team is organized Chair
4 Review of protocol, informed consent, post approval documents, educational materials approved by the AUF IERC prior to the visit. Site visit team
5 Inspection of study site, interview of participants, accomplishments of site visit assessment form Site visit team
6 Submission of site visit assessment form to the committee secretary within two weeks after the visit Site visit team
7 Inclusion of the report in the agenda of the next meeting Committee Secretary
8 Presentation of findings to the full board meeting Site visit team
9 Decision by consensus AUF IERC
10 Action whether to uphold the original approval and continue monitoring: suspend approval pending compliance with the recommendation, termination of approval. AUF IERC

 

 



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