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

<ordinal> REGULAR MEETING
<dd/mm/yyyy>, Venue, Time
ATTENDANCE
PRESENT
ABSENT
Member 2
Member 2
Member 1
Member 1
Member 3
Member 4
Member 5
Member 6
Member 7
Others:
Panel Staf
1. CALL TO ORDER
<Title, First Name, Surname>, Panel Chair, called this regular meeting to order at <time> AM.
2. DETERMINATION OF QUORUM
A quorum was declared with the presence of <number> members, inclusive of the presence of
<number> non-institutional and <number> lay members, and as confirmed by the Panel
Secretary, <Title, Name, Surname>.
3. DISCLOSURE OF CONFLICT OF INTEREST

<Title, Surname of Panel Chair>, 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:
<Title, Name, Surname> as Principal Investigator for the study entitled, TITLE (STUDY
PROTOCOL NUMBER)
4. READING AND APPROVAL OF THE MINUTES OF THE LAST MEETING

<Title, Surname of Panel Chair> presided over the discussion of the minutes of the (UPMREB
Review Panel) meeting held last <dd/mm/yyyy> (Date of last meeting). The minutes were
corrected during the discussion and approved as amended.
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5. BUSINESS ARISING FROM THE MINUTES OF THE LAST MEETING

5.1. Corrections in the Minutes
5.2. Matters requiring UPMREB Panel action
6. 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
soundness
Assessment of ethical issues
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
1.
2.
3.
4.
5.
6.
7.
8.
Objectives/Expected output
Literature review
Research design
Sampling design, sample size
Inclusion criteria, exclusion criteria, withdrawal criteria
Specimen collection and processing
Statistical and data analysis plan
PI qualifications
Suitability and choice of site
Validation of research instruments among Filipino participants
Conflict of Interest:
Privacy and confidentiality including data protection plan
Vulnerability
Risks
Benefits
Informed consent process and recruitment:
Informed Consent Form (ICF) (including translation)
Documentation of collaborative study TOR
Decision (Approve <date of continuing review>, 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
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6.1.2. Resubmissions or Study Protocols for Modification
UPMREB 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
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
Decision (Approve <date of continuing review>, 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
Approval expiration date (if

applicable)
Frequency of continuing review
(in case of approval
Reasons
6.1.3. Study Protocols for Clarificatory Interview
UPMREB Code
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Assessment of PI responses
to Panel queries
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
Decision (Decisions are based on the Panels assessment of the PIs response
to their queries.)
Reasons
6.1.4. Withdrawal of Study Protocol Applications
UPMREB Code
Withdrawal Application Date
<dd/mm/yyyy>
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Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Assessment of reasons for
Study Protocol withdrawal
Conclusion and
recommendations
Action taken
Decision (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 Applications
UPMREB Code
Study Protocol Approval Date
Amendment Submission Date
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Assessment of amendment
requested
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision (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
Reasons
6.1.6. Continuing Review Applications
UPMREB Code
Application Date
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Assessment of progress
<dd/mm/yyyy>
<dd/mm/yyyy>
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reported
Conclusion and
recommendations
Action taken

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
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision 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) Reports
UPMREB Code
Report Date
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Assessment of NonCompliance Report 1:
Conclusion and
recommendations
Action taken
Reasons
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision (No further action required, Request information, Recommend further

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

action, Pending, if major clarifications are required before a decision can be
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made)
Reasons
Conclusion and
recommendations
Action taken
Decision (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
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>

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
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision (No further action, Request information, Recommend further action,

Reasons
6.1.11. SAE and SUSAR Reports
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UPMREB Code
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<dd/mm/yyyy>
Report Date
<dd/mm/yyyy>
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Assessment of SAEs
reported
SAE 1 Submission Date
Date of SAE
Date of
randomization
Age
Sex
Country
Nature of AE
Co-morbidities
Status
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision Points (No further action required, Request information, Recommend

further action, Pending, if major clarifications are required before a decision can
be made)
Reasons
SAE 2 Submission Date
Date of SAE
Date of
randomization
Age
Sex
Country
Nature of SAE
Co-morbidities
Status
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
<dd/mm/yyyy>

be made)
Reasons
6.1.12. Site Visit Reports
UPMREB Code
Site Visit Date
Type of Review
Primary Reviewers
<dd/mm/yyyy>
<dd/mm/yyyy>
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Technical Review
Sponsor/CRO
Quorum status
Assessment of Site Visit
Report
Conclusion and
recommendations
Action taken

be made)
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
<dd/mm/yyyy>
<dd/mm/yyyy>
6.2.2. Study Protocols for Initial Review
UPMREB Code
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
Decision (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
<dd/mm/yyyy>
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Sponsor/CRO
Action taken
Decision (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 taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision (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 Applications
UPMREB Code
Date of Report
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision (Approve, Request information, Recommend further action,

6.2.6. Final Reports
UPMREB Code
Date of Report
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision Points (Approve, Request information, Recommend further action,

6.2.7. Study Protocol Non-Compliance (Deviation or Violation) Reports
UPMREB Code
<dd/mm/yyyy>
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Date of Report
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
Decision (No further action, Request information, Recommend further action,

6.2.8. Early Study Termination Applications
UPMREB Code
Application Date
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
6.2.9.
<dd/mm/yyyy>
<dd/mm/yyyy>
Decision (Approve, Request information, Recommend further action,

Queries, Notifications, and Complaints
UPMREB Code
Application Date
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>

7. OTHER MATTERS
8. ADJOURNMENT
Meeting was adjourned at <time>
Prepared by:
DATE:
<dd/mm/yyyy>
Signature over <Title, Name, Surname>

SECRETARIAT STAFF
Checked by:
DATE:
<dd/mm/yyyy>

PANEL SECRETARY
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Approved by:
DATE:
<dd/mm/yyyy>

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

Minutes of the NAME OF PANEL

3. DISCLOSURE OF CONFLICT OF INTEREST

4. READING AND APPROVAL OF THE MINUTES OF THE LAST MEETING