The Standard Operating Procedures (SOP) of the BATMC Research Ethics Review Committee (RERC) provide a structured guide for the ethical review of research involving human participants. These procedures ensure that all research protocols submitted to the Committee are reviewed in accordance with national and international ethical standards, including the guidelines set by the Philippine Health Research Ethics Board (PHREB).
The SOP outlines the roles and responsibilities of the Committee, the submission and review processes, decision-making procedures, and monitoring requirements for approved studies. It aims to promote transparency, consistency, and accountability in the ethics review process while safeguarding the rights, safety, and welfare of research participants
Form 2.6.1 -Site Resources Checklist
Form 2.6.2-Site Resources Checklist-ousite BatMC
Form 2.7.1-Protocol Package Checklists
Form 2.7.2-Application Form for Protocol Review
Form 2.7.3- Protocol Evaluation Form
Form 2.7.4-Protocol Summary Sheet
Form 2.7.5-Non Disclosure Agreement (BatMC Personnel)
Form 2.7.6-Non Disclosure Agreement (Site Outside BatMC)
Form 2.11.1-Reviewer Checklist for Exemption
Form 2.15.1-Study Protocol Assessment
Form 2.15.2- Informed Consent Assessment
Form 2.15.3-Medical Device Assessment Form
Form 2.16.1-Review of Resubmitted Study Protocol
BATMC RERC ICF ADAPTED from WHO TEMPLATE FOR ICF FOR CLINICAL STUDIES
BATMC RERC ICF ADAPTED from WHO TEMPLATE FOR INFORMED ASSENT
BATMC RERC ICF ADAPTED from WHO TEMPLATE ICF FOR QUALITATIVE STUDIES INTERVIEWS
BATMC RERC ICF ADAPTED from WHO TEMPLATE ICF PARENTAL CONSENT FOR QUALITATIVE STUDIES IN CHILDREN
BATMC RERC ICF ADAPTED ICF from WHO TEMPLATE FOR ICF FOR SAMPLE STORAGE
Form 3.17.1-Protocol Amendment Review
Form 3.18.1-Progress Report/ Application for Continuing Review
Form 3.19.1-Deviation/Non Compliance/Violation Report/Summary Report
Form 3.20.1-SAE_ SUSAR Summary Report (On Site)
Form 3.20.1A SAE _SUSAR REPORT
Form 3.21.1-Report of Negative Events
Form 3.22.1-Early Study Termination