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UPMREB FORM 2 (A) 2012 Review Checklist

This document is a review checklist for a study protocol submitted to the University of the Philippines Manila Research Ethics Board (UPMREB). It includes information about the study such as the reference number, title, principal investigator, and date of submission. It lists the types of documents that are required to be submitted for initial review, including the study protocol, informed consent forms, CVs of the research team, and proof of payment of ethics fees. It also lists additional documents that may be required depending on the study, such as an investigator's brochure for clinical trials, assent forms if the study involves minors, and approvals from other regulatory authorities.

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558 views2 pages

UPMREB FORM 2 (A) 2012 Review Checklist

This document is a review checklist for a study protocol submitted to the University of the Philippines Manila Research Ethics Board (UPMREB). It includes information about the study such as the reference number, title, principal investigator, and date of submission. It lists the types of documents that are required to be submitted for initial review, including the study protocol, informed consent forms, CVs of the research team, and proof of payment of ethics fees. It also lists additional documents that may be required depending on the study, such as an investigator's brochure for clinical trials, assent forms if the study involves minors, and approvals from other regulatory authorities.

Uploaded by

echo alisbo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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UPMREB FORM 2(A)2012: REVIEW CHECKLIST

29/07/2019

Review Checklist
STUDY PROTOCOL INFORMATION
Reference Number:1
UPMREB Code:2
Study Protocol Title:
Principal Investigator: <Title, Name, Surname>
Study Protocol Submission Date: <dd/mm/yyyy>
(to be accomplished by UPMREB Staff)
Verified Complete by: <Signature over Printed Name>
(to be accomplished by UPMREB Staff)
Classification of Review:  EXPEDITED
(to be accomplished by UPMREB)  FULL BOARD
 EXEMPTED
Classified by the: <Signature over Printed Name>
 UPMREB CHAIR
 UPMREB COORDINATOR
UPMREB Form (Type of Submission)
 UPMREB FORM 2(B)2012 Printed Registration and Application Form
 UPMREB FORM 2(C)2012 Study Protocol Assessment Form
 UPMREB FORM 2(H)2012 Review of Resubmitted Protocol Form
 UPMREB FORM 3(A)2012 Study Protocol Amendment Submission Form
 UPMREB FORM 3(B)2012 Continuing Review Application Form
 UPMREB FORM 3(C)2012 Final Report Form
 UPMREB FORM 3(D)2012 Study Non-Compliance Report
 UPMREB FORM 3(E)2012 Early Study Termination Application Form
 UPMREB FORM 3(G)2016 Suspected Unexpected Serious Adverse Events/Reactions
Report
 UPMREB FORM 3(I)2012 Queries Notification and Complaints
Basic Documents (must submit for initial review)
 Research Grants Administration Office (RGAO) Endorsement (refer to UPMREB General
Policies and Guidelines for description of RGAO)
 UPMREB FORM 2(A)2012 Review Checklist
 Study Protocol
 Data collection forms (including CRFs)
 Diagrammatic workflow
 CV of PI and study team members
 Proof of payment of ethics review fee (as applicable)
Study-specific Documents (submit as needed)
 Investigator’s Brochure (for clinical trials phase I, II, III) or Basic Product Information
Document (for clinical trials phase IV)
 UPMREB FORM 2(D)2012 Informed Consent Assessment Form (for studies with human
participants)
 Informed consent form in English (for studies with human participants)
 Informed consent form in local language (for studies with human participants)

1
To be issued upon RGAO registration
2
To be issued upon initial processing by UPMREB
UPMREB FORM 2(A)2012: REVIEW CHECKLIST
29/07/2019

 Assent form in English (for studies involving minors and relevant populations deemed
incompetent to sign an informed consent form )
 Assent form in local language (for studies involving minors and relevant populations
deemed incompetent to sign an informed consent form)
 Good Clinical Practice (GCP) or Health Research Ethics Training Certificate of PI, Co-I
and the rest of the study team (GCP is required for clinical trials)
 Recruitment advertisements (as needed by the study protocol)
 Other information or documents for participants (such as diaries, etc.)
 Material Transfer Agreement or Terms of Reference (for any research involving transfer
of biological specimens)
 Memorandum of Agreement (for collaborative studies)
 RGAO-endorsed Clinical Trial Agreement (for clinical trials done in UP-PGH; processed
separately by the UPM Legal Office and to be submitted to RGAO upon receipt of
notification of ethical approval from UPMREB)
 UPMREB FORM 2(E)2012 Site Resources Checklist for Clinical Trial Outside UP-PGH By
UPM Personnel
 UPMREB FORM 2(F)2012 Site Resources Checklist for Clinical Trial Outside UP-PGH By
non-UPM Personnel
 Previous ethical review approvals/clearances (for students/personnel of foreign
universities researching in the Philippines or those with prior ethical review)
 National Commission for Indigenous People (NCIP) Clearance (for studies with
indigenous populations; can be processed while UPMREB review is ongoing)
 Clearance or permit from respective regulatory authorities (such as FDA approval for
clinical trials and DENR local transport permit, as applicable)
 Others (specify):

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