Documentos de Académico
Documentos de Profesional
Documentos de Cultura
30/01/2014
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>.
Page 1 of 12
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
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
UPMREB Code
Study Protocol Resubmission
Date
Study Protocol Title
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>
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 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
Study Protocol Title
<dd/mm/yyyy>
Page 3 of 12
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of reasons for
Study Protocol withdrawal
Conclusion and
recommendations
Action taken
Reasons
6.1.5. Study Protocol Amendment Applications
UPMREB Code
Study Protocol Approval Date
Amendment Submission Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of amendment
requested
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Reasons
6.1.6. Continuing Review Applications
UPMREB Code
Study Protocol Approval Date
Application Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of progress
<dd/mm/yyyy>
<dd/mm/yyyy>
Page 4 of 12
reported
Conclusion and
recommendations
Action taken
Reasons
6.1.7. Final Reports
UPMREB Code
Study Protocol Approval Date
Report Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of final report
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Reasons
6.1.8. Study Protocol Non-Compliance (Deviation or Violation) Reports
UPMREB Code
Study Protocol Approval Date
Report Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of NonCompliance Report 1:
Conclusion and
recommendations
Action taken
Reasons
Assessment of NonCompliance Report 2:
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
made)
Reasons
Assessment of NonCompliance Report 3:
Conclusion and
recommendations
Action taken
Reasons
6.1.9. Early Study Termination Applications
UPMREB Code
Study Protocol Approval Date
Application Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of risks from
early termination
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Reasons
6.1.10.
UPMREB Code
Study Protocol Approval Date
Application Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of query or
complaint
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
Reasons
6.1.11. SAE and SUSAR Reports
Page 6 of 12
UPMREB Code
Page 7 of 12
Conclusion and
recommendations
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
<dd/mm/yyyy>
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>
Reasons
6.1.12. Site Visit Reports
UPMREB Code
Study Protocol Approval Date
Site Visit Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
<dd/mm/yyyy>
<dd/mm/yyyy>
Page 8 of 12
Technical Review
Sponsor/CRO
Quorum status
Conflict of Interest:
Assessment of Site Visit
Report
Conclusion and
recommendations
Action taken
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
Study Protocol Submission Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Study Protocol Approval Date
<dd/mm/yyyy>
<dd/mm/yyyy>
UPMREB Code
Study Protocol Submission Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
UPMREB Code
Study Protocol Submission Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
<dd/mm/yyyy>
Page 9 of 12
Sponsor/CRO
Action taken
UPMREB Code
Study Protocol Approval Date
Date of Amendment Submission
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
UPMREB Code
Study Protocol Approval Date
Date of Report
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
UPMREB Code
Study Protocol Approval Date
Date of Report
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
<dd/mm/yyyy>
UPMREB Code
Study Protocol Approval Date
<dd/mm/yyyy>
Page 10 of 12
Date of Report
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
<dd/mm/yyyy>
UPMREB Code
Study Protocol Approval Date
Application Date
Study Protocol Title
Principal Investigator
Type of Review
Primary Reviewers
Technical Review
Sponsor/CRO
Action taken
6.2.9.
<dd/mm/yyyy>
<dd/mm/yyyy>
UPMREB Code
Study Protocol Approval Date
Application Date
Study Protocol Title
Principal Investigator
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>
Checked by:
DATE:
<dd/mm/yyyy>
Page 11 of 12
Approved by:
DATE:
<dd/mm/yyyy>
Page 12 of 12