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“headline”: “SOP for REB Requirements and Reporting Timelines”,
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“description”: “Comprehensive SOP describing Research Ethics Board submission and reporting requirements, including initial submissions, continuing reviews, amendments, safety updates, and communication logs to ensure ethics oversight compliance.”,
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REB Requirements and Reporting Timelines SOP

Purpose

This SOP defines the process for submitting documents, obtaining approvals, and reporting to Research Ethics Boards (REBs) to ensure compliance with Division 5 and ICH-GCP requirements. It establishes timelines, documentation standards, and communication pathways to safeguard participant rights and maintain regulatory oversight throughout the clinical trial lifecycle.

Scope

This SOP applies to all REB submissions related to clinical trials sponsored or overseen by the organization. It covers initial submissions, continuing reviews, amendments, safety updates, annual renewals, study termination, and urgent notifications (e.g., protocol deviations impacting subject safety). It is applicable to investigators, site staff, sponsors, regulatory affairs, and clinical research teams operating in compliance with GCP.

Responsibilities

• Principal Investigator (PI): Submits initial and ongoing documentation to the REB, responds to REB queries, and ensures site staff compliance.
• Clinical Research Coordinator (CRC): Prepares submissions, maintains correspondence logs, and tracks timelines for continuing reviews and renewals.
• Regulatory Affairs (RA): Provides regulatory documentation, ensures alignment of REB submissions with CTA dossier, and files acknowledgments in TMF.
• Sponsor/Clinical Project Manager: Oversees REB submission strategy across multiple sites, monitors compliance with timelines, and supports corrective actions.
• Quality Assurance (QA): Audits REB submission packages and correspondence to ensure completeness, accuracy, and inspection readiness.

Accountability

The Principal Investigator is accountable for ensuring timely submission of ethics documents and adherence to REB reporting requirements. The Head of Clinical Research is accountable for oversight and compliance monitoring across studies.

Procedure

1. Initial REB Submission

1. Compile protocol, Investigator’s Brochure (IB), informed consent forms (ICFs), recruitment materials, and relevant safety data.
2. Submit documentation to REB prior to trial initiation and maintain an indexed REB submission file.
3. Record REB approval number, validity dates, and conditions of approval in REB Approval Log.

2. Amendments

1. Submit substantial protocol amendments, revised ICFs, and updated safety data to REB before implementation, unless urgent safety measures are required.
2. Maintain Amendment Log tracking submission dates, approvals, and site-level implementation status.

3. Continuing Review and Renewals

1. Prepare annual progress reports summarizing enrollment, safety events, deviations, and benefit-risk updates.
2. Submit renewal packages at least 30 days before REB approval expiry to ensure uninterrupted trial conduct.

4. Safety Reporting

1. Report unanticipated problems involving risks to participants to REB within 7 days of awareness.
2. Submit expedited reports for SUSARs and periodic updates summarizing safety data.

5. Study Closure

1. Submit final report including enrollment summary, outcomes, and CSR reference to REB after trial completion or early termination.
2. Ensure documentation of REB closure acknowledgment in TMF and ISF.

6. Documentation and Record-Keeping

1. Maintain REB Submission Log, Amendment Log, Safety Reporting Log, and Communication Log in TMF.
2. Archive all REB approvals, correspondence, and supporting documents per retention timelines.

Abbreviations

• REB: Research Ethics Board
• PI: Principal Investigator
• CRC: Clinical Research Coordinator
• CTA: Clinical Trial Application
• CSR: Clinical Study Report
• SUSAR: Suspected Unexpected Serious Adverse Reaction
• TMF: Trial Master File
• QA: Quality Assurance

Documents

1. REB Submission Log (Annexure-1)
2. Amendment Log (Annexure-2)
3. REB Communication Log (Annexure-3)

References

• Health Canada — Clinical Trial Guidance
• Food and Drug Regulations — Division 5
• ICH E6(R2) Good Clinical Practice
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

Version: 1.0

Approval

Annexures

Annexure-1: REB Submission Log

Annexure-2: Amendment Log

Annexure-3: REB Communication Log

Revision History

For more SOPs visit: Pharma SOP.