ERC Form 2A: Notice of Meeting
UNIVERSITY OF THE EAST RAMON MAGSAYSAY MEMORIAL MEDICAL CENTER, INC.
Aurora Boulevard, Quezon City
Research Institute for Health Sciences
ETHICS REVIEW COMMITTEE
Date of issuance: <mm/dd/yyyy>
NOTICE OF MEETING
TO:
<NAME OF RIHS ERC REVIEW PANEL> Members:
Name 1
Name 2
Name 3
Name 4
Name 5
Name 6
Name 7
Name 8
DATE OF MEETING:
TIME OF MEETING:
VENUE OF MEETING:
AGENDA:
1.
2.
3.
4.
5.
6.
Call to order
Determination of quorum and presence of non-institutional members
Disclosure of Conflict of interest
Reading and approval of the Minutes of the last meeting
Business arising from the Minutes of the last meeting
Protocol review
1
ERC Form 2A: Notice of Meeting Version 2 dated August 01 2014 UERMMMCI
ERC Form 2A: Notice of Meeting
6.1.
FULL REVIEW
6.1.1. Study Protocols for Initial Review
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.2. Resubmissions or Study Protocols for Modification
RIHS ERC Code
Study Protocol Submission Date <mm/dd//yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.3. Study Protocols for Clarificatory Interview
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.4. Withdrawal of Study Protocol Applications
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Withdrawal Application Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.5. Study Protocol Amendment Applications
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Amendment Submission Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
2
ERC Form 2A: Notice of Meeting Version 2 dated August 01 2014 UERMMMCI
ERC Form 2A: Notice of Meeting
6.1.6. Continuing Review Applications
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Application Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.7. Final Reports
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Report Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.8. Study Protocol Non-Compliance (Deviation or Violation) Reports:
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Report Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.9. Early Study Termination Application
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Application Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.10. Queries or Complaints
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Report Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
3
ERC Form 2A: Notice of Meeting Version 2 dated August 01 2014 UERMMMCI
ERC Form 2A: Notice of Meeting
6.1.11. SAE and SUSAR Reports
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Report Date
<mm/dd/yyyy> (Organize SAEs under one protocol by date)
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
6.1.12. Site Visit Reports:
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Site Visit Date
<mm/dd/yyyy>
Study Protocol Title
Principal investigator
Type of review
Primary reviewers
Technical Review
Sponsor
6.2.
REPORT OF PROTOCOL SUBMISSIONS FOR EXPEDITED REVIEW AND
FULL BOARD PROTOCOLS WITH MODIFICATION EXPEDITED AT THE
LEVEL OF THE CHAIR
7. Other Matters
8. Adjournment
<TITLE, NAME, SURNAME> and SIGNATURE
Chair, RIHS ERC Review Panel
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ERC Form 2A: Notice of Meeting Version 2 dated August 01 2014 UERMMMCI
ERC Form 2A: Notice of Meeting
ANNEX 1
Report of Protocol Submissions for Expedited Review and Full Board Protocols with
Modification Expedited at the Level of the Chair
1.
Approved Protocols
RIHS ERC Code
Study Protocol Approval Date
Study Protocol Submission Date
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
<mm/dd/yyyy>
<mm/dd/yyyy>
ACTION
2. Study Protocols for Initial Review
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
ACTION
3. Resubmissions or Study Protocols for Modification
RIHS ERC Code
Study Protocol Submission Date <mm/dd/yyyy>
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
ACTION
4. Study Protocol Amendments Applications
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Amendment Submission Date
<mm/dd/yyyy>
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
ACTION
5
ERC Form 2A: Notice of Meeting Version 2 dated August 01 2014 UERMMMCI
ERC Form 2A: Notice of Meeting
5. Continuing Review Applications
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Application Date
<mm/dd/yyyy>
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
ACTION
6. Final Reports
RIHS ERC Code
Study Protocol Approval Date
Report Date
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
ACTION
<mm/dd/yyyy>
<mm/dd/yyyy>
7. Study Protocol Non-Compliance (Deviation or Violation) Reports
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Report Date
<mm/dd/yyyy>
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
ACTION
8. Early Study Termination Applications
RIHS ERC Code
Study Protocol Approval Date
<mm/dd/yyyy>
Application Date
<mm/dd/yyyy>
Study Protocol Title
Principal Investigator
Type of review
Primary reviewers
ACTION
6
ERC Form 2A: Notice of Meeting Version 2 dated August 01 2014 UERMMMCI