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