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RERC Manual and Forms

RERC Manual
RERC Forms

RERC Manual

Research Ethics Review Committee Manual

BATMC RERC SOP Manual version 5.7

BATMC RERC Standard Forms Workbook Version 5.7

Form 5.36.1 - Request for Revision of an SOP or Guidelines

RERC Forms

BATMC RERC ICF ADAPTED from WHO template for ICF for Clinical Studies

BATMC RERC ICF ADAPTED from WHO Template for ICF for Informed Assent

BATMC RERC ICF ADAPTED from WHO Template for ICF for Qualitative Studies Interviews

BATMC RERC ICF ADAPTED from WHO Template for ICF Parental Consent for Qualitative Studies in Children

BATMC RERC ICF ADAPTED from WHO Template For ICF for Sample Storage

Complete Protocol Packages

Form 2.6.1 Protocol Package Checklist WHO ICF Templates

Form 2.6.2 Application form for Protocol Review

Form 2.6.3 Protocol Evaluation Form

Form 2.6.4 Protocol Summary Sheet

Form 2.6.5 Non-Disclosure Agreement

Form 2.6.6 Non-Disclosure Agreement Outside BatMC

Form 2.14.1 Study Protocol Assessment

Form 2.14.2 Informed Consent Assessment

Form 2.15.1 Review of Resubmitted Protocol

Form_3.16.1 Protocol Amendment Review

Form 3.17.1 Progress Report

Form 3.18.1 Deviation Non-Compliance Violation

Form 3.19.1 A-SAE SUSAR REPORT

Form 3.19.1 B Report of Negative Events

Form 3.19.2 A-SAE SUSAR Summary Report Onsite

Form 3.19.3 A-SAE SUSAR Summary Report Offsite

Form 3.20.1 Early Study Termination

Form 3.21.1 Application for Continuing Review

Form 3.22.1 Final Report

Form 3.23.1 Letter of Appeal Re RERC Decision

SJREB Form 2 - Protocol Assessment Form 2

SJREB Form 3 - Informed Consent Assessment Form 4