UPMREB FORM 4(a)2012 Format of the Minutes of the Meeting_0

UPMREB FORM 4(A) 2012: FORMAT OF THE MINUTES OF THE MEETING

30/01/2014

Minutes of the NAME OF PANEL

REGULAR MEETING

, Venue, Time

ATTENDANCE

PRESENTABSENT

Member 1Member 2

Member 3

Member 4

Member 5

Member 6

Member 7Others:

Panel StaffMember 1Member 2

1. CALL TO ORDER

, Panel Chair, called this regular meeting to order at AM.2. DETERMINATION OF QUORUMA quorum was declared with the presence of members, inclusive of the presence of non-institutional and lay members, and as confirmed by the Panel Secretary, .3. DISCLOSURE OF CONFLICT OF INTEREST

, called for disclosure of Conflict of Interest (COI) in the Study Protocols scheduled for deliberation in the meeting. The following member/s inhibited from participation in the panel deliberations during the full board meeting for the following reasons:

as Principal Investigator for the study entitled, TITLE (STUDY PROTOCOL NUMBER)4. READING AND APPROVAL OF THE MINUTES OF THE LAST MEETING

presided over the discussion of the minutes of the (UPMREB Review Panel) meeting held last (Date of last meeting). The minutes were corrected during the discussion and approved as amended.

5. BUSINESS ARISING FROM THE MINUTES OF THE LAST MEETING

5.1. Corrections in the Minutes5.2. Matters requiring UPMREB Panel action6. STUDY PROTOCOL REVIEW

6.1. FULL REVIEW

6.1.1. Study Protocols for Initial Review

UPMREB Code

Study Protocol Submission Date

Study Protocol Title

Principal investigator

Type of review

Primary reviewers

Technical Review

Sponsor/CRO

Quorum status

Conflict of interest

Assessment of scientific soundness1. Objectives/Expected output

2. Literature review

3. Research design

4. Sampling design, sample size

5. Inclusion criteria, exclusion criteria, withdrawal criteria

6. Specimen collection and processing

7. Statistical and data analysis plan

8. PI qualifications

9. Suitability and choice of site

10. Validation of research instruments among Filipino participants

Assessment of ethical issues1. Conflict of Interest:

2. Privacy and confidentiality including data protection plan

3. Vulnerability

4. Risks

5. Benefits

6. Informed consent process and recruitment: 7. Informed Consent Form (ICF) (including translation)

8. Documentation of collaborative study TOR

Conclusion and recommendations

Action takenDecision (Approve , Major Modification, which require full board deliberation, Minor Modification, which can be expedited at the level of the Panel Chair, Disapprove, Pending, if major clarifications are required before a decision can be made)

Approval expiration date (if applicable)

Frequency of continuing review (in case of approval

Reasons

6.1.2. Resubmissions or Study Protocols for ModificationUPMREB Code

Study Protocol Resubmission Date


Principal Investigator

Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status

Conflict of Interest

Assessment of PI response to initial review


Action takenDecision (Approve , Major Modification, which require full board deliberation, Minor Modification, which can be expedited at the level of the Panel Chair, Disapprove, Pending, if major clarifications are required before a decision can be made)

Approval expiration date (if applicable)

Frequency of continuing review (in case of approval

Reasons

6.1.3. Study Protocols for Clarificatory InterviewUPMREB Code




Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status

Conflict of Interest:

Assessment of PI responses to Panel queries


Action takenDecision (Decisions are based on the Panels assessment of the PIs response to their queries.)

Reasons

6.1.4. Withdrawal of Study Protocol ApplicationsUPMREB Code

Withdrawal Application Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of reasons for Study Protocol withdrawal


Action takenDecision (Approve, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

Reasons

6.1.5. Study Protocol Amendment ApplicationsUPMREB Code

Study Protocol Approval Date

Amendment Submission Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of amendment requested


Action takenDecision (Approve, Minor modification to the study protocol amendment, citing reasons for action, subject to expedited review at the level of the Panel Chair, Major modification to the study protocol amendment, stating reasons for action, subject to full board review, Disapprove, Pending, if major clarifications are required before a decision can be made)

Reasons

6.1.6. Continuing Review ApplicationsUPMREB Code


Application Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of progress reported



Reasons

6.1.7. Final Reports

UPMREB Code


Report Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of final report


Action takenDecision Points (Approve, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

Reasons

6.1.8. Study Protocol Non-Compliance (Deviation or Violation) ReportsUPMREB Code


Report Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of Non-Compliance Report 1:


Action takenDecision (No further action required, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

Reasons



Action takenDecision (No further action required, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

Reasons



Action takenDecision (Approve, Request information, Recommend further action, Forward to AE Subcommittee)

Reasons

6.1.9. Early Study Termination Applications

UPMREB Code


Application Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of risks from early termination



Reasons

6.1.10. Queries, Notifications, and Complaints

UPMREB Code


Application Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of query or complaint


Action takenDecision (No further action, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

Reasons

6.1.11. SAE and SUSAR ReportsUPMREB Code


Report Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of SAEs reported

SAE 1Submission Date

Date of SAE

Date of randomization

Age

Sex

Country

Nature of AE

Co-morbidities

Status


Action takenDecision Points (No further action required, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

Reasons

SAE 2Submission Date

Date of SAE

Date of randomization

Age

Sex

Country

Nature of SAE

Co-morbidities

Status



Reasons

6.1.12. Site Visit Reports

UPMREB Code


Site Visit Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Quorum status


Assessment of Site Visit Report



Reasons

6.2. REPORT OF PROTOCOL SUBMISSIONS FOR EXPEDITED REVIEW AND FULL BOARD PROTOCOLS WITH MODIFICATION EXPEDITED AT THE LEVEL OF THE CHAIR

6.2.1. Approved Protocols

UPMREB Code




Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO


6.2.2. Study Protocols for Initial Review

UPMREB Code




Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Action takenDecision (Approve, Major Modification, which require full board deliberation, Minor Modification, which can be expedited at the level of the Panel Chair, Disapprove, Pending, if major clarifications are required before a decision can be made)

6.2.3. Resubmissions (study protocols for modification)UPMREB Code




Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Action takenDecision (Approve, Major Modification, which require full board deliberation, Minor Modification, which can be expedited at the level of the Panel Chair, Disapprove, Pending, if major clarifications are required before a decision can be made)

6.2.4. Study Protocol Amendments

UPMREB Code


Date of Amendment Submission



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Action takenDecision (Approval, Minor modification to the study protocol amendment, citing reasons for action, subject to expedited review at the level of the Panel Chair, Major modification to the study protocol amendment, stating reasons for action, subject to full board review, Disapprove, Pending, if major clarifications are required before a decision can be made)

6.2.5. Continuing Review ApplicationsUPMREB Code


Date of Report



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO


6.2.6. Final Reports

UPMREB Code


Date of Report



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Action takenDecision Points (Approve, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

6.2.7. Study Protocol Non-Compliance (Deviation or Violation) Reports

UPMREB Code


Date of Report



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO

Action takenDecision (No further action, Request information, Recommend further action, Pending, if major clarifications are required before a decision can be made)

6.2.8. Early Study Termination ApplicationsUPMREB Code


Application Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO


6.2.9. Queries, Notifications, and ComplaintsUPMREB Code


Application Date



Type of Review

Primary Reviewers

Technical Review

Sponsor/CRO


7. OTHER MATTERS

8. ADJOURNMENT

Meeting was adjourned at Prepared by:Signature over

DATE: SECRETARIAT STAFF

Checked by:Signature over

DATE: PANEL SECRETARY

Approved by:Signature over

DATE: PANEL CHAIR

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UPMREB FORM 4(a)2012 Format of the Minutes of the Meeting_0