Standard Operating Procedure for Developing Study Synopsis for Ethics Submission in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/007/2025 |
| Supersedes | SOP/BA-BE/007/2022 |
| Page No. | Page 1 of 12 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the standard procedure for developing a study synopsis for submission to Ethics Committees or Institutional Review Boards (IRBs) during the approval process for Bioavailability/Bioequivalence (BA/BE) studies.
2. Scope
This SOP applies to all personnel involved in the preparation, review, and submission of study synopses for BA/BE clinical trials to Ethics Committees (EC) and IRBs as part of the regulatory and ethical approval process.
3. Responsibilities
- Medical Writer: Prepares the draft synopsis using the standard template.
- Clinical Research Team: Provides key study parameters and design inputs.
- Regulatory Affairs: Ensures compliance with national EC/IRB requirements.
- Quality Assurance: Reviews for completeness and GCP compliance before submission.
4. Accountability
The Head of Clinical Operations is accountable for ensuring the accuracy, regulatory compliance, and timely submission of the study synopsis to the appropriate Ethics Committee or IRB.
5. Procedure
5.1 Initiation of Synopsis Preparation
- Initiate synopsis development after study design finalization and dose selection.
- Use the current version of the Ethics Synopsis Template (Annexure-1).
5.2 Key Components of the Synopsis
- The synopsis shall contain:
- Study title and protocol number
- Sponsor and CRO details
- Study objectives
- Design (open label, randomized, crossover/parallel)
- Dose and formulation details
- Sample size and subject population
- Inclusion and exclusion criteria (summary)
- Safety monitoring plan
- Informed consent process summary
- Study duration and key timelines
5.3 Review and Quality Control
- Share draft synopsis with the clinical team and sponsor for review.
- Conduct internal QA check to ensure:
- Consistency with protocol
- Clarity of scientific rationale
- Alignment with GCP and EC guidelines
- Make necessary revisions based on review comments.
5.4 Finalization and Version Control
- Assign version number as per SOP for document control (e.g., Version 2.0).
- Lock the final version in PDF format and archive in the eTMF “EC Submission” section.
5.5 Submission to Ethics Committee
- Include the finalized synopsis as part of the Ethics Submission Package.
- Submit as per the EC’s checklist and in the required format (physical/electronic).
- Retain acknowledgment and correspondence as per archival policy.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- EC: Ethics Committee
- IRB: Institutional Review Board
- eTMF: Electronic Trial Master File
- GCP: Good Clinical Practice
7. Documents
- Study Synopsis Template – Annexure-1
- Synopsis Review Checklist – Annexure-2
- Ethics Committee Submission Tracker – Annexure-3
8. References
- ICH E6 (R2) – Good Clinical Practice
- Schedule Y of Drugs and Cosmetics Act (India)
- USFDA and EMA Guidance on Informed Consent and Ethics Review
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Study Synopsis Template
| Field | Details |
|---|---|
| Study Title | Comparative Bioequivalence Study of XYZ 100 mg |
| Design | Open Label, Randomized, 2×2 Crossover |
| Sample Size | 36 subjects |
| Primary Objective | To assess bioequivalence between test and reference |
Annexure-2: Synopsis Review Checklist
| Review Item | Status | Reviewer | Date |
|---|---|---|---|
| Title accuracy | Yes | Rajesh Kumar | 12/04/2025 |
| Objective clarity | Yes | Sunita Reddy | 13/04/2025 |
Annexure-3: Ethics Committee Submission Tracker
| Submission Date | EC Name | Mode | Acknowledgment Received | Status |
|---|---|---|---|---|
| 15/04/2025 | Institutional Ethics Committee, Mumbai | Physical | Yes | Under Review |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial SOP Release | New SOP | QA Head |
| 17/04/2025 | 2.0 | Updated annexures and alignment with Schedule Y | Annual Review | QA Head |