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“headline”: “SOP for Publication Policy and Disclosure/Transparency”,
“description”: “This SOP defines procedures for clinical trial publication policy and disclosure/transparency requirements, ensuring compliance with FDA, EMA, CDSCO, WHO, and ICH GCP guidelines. It covers publication planning, authorship, data disclosure, lay summaries, and public transparency obligations.”,
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Published on 27/12/2025
Standard Operating Procedure for Publication Policy and Disclosure/Transparency
| SOP No. | CR/OPS/104/2025 |
| Supersedes | NA |
| Page No. | 1 of 46 |
| Issue Date | 26/08/2025 |
| Effective Date | 01/09/2025 |
| Review Date | 01/09/2026 |
Purpose
The purpose of this SOP is to outline the publication policy and disclosure/transparency practices for clinical trials. It ensures accurate, timely, and unbiased dissemination of trial results to
Scope
This SOP applies to sponsors, investigators, CROs, regulatory affairs, medical writers, and communication teams involved in publishing trial data and disclosing results. It includes manuscripts, abstracts, posters, lay summaries, trial registries, and transparency disclosures across FDA, EMA, CDSCO, and WHO-regulated trials.
Responsibilities
- Sponsor: Establishes publication policy and ensures compliance with transparency regulations.
- Medical Writing Team: Drafts manuscripts, abstracts, and lay summaries in alignment with ICMJE guidelines.
- Investigators: Provide input on authorship, ensure accurate data representation, and comply with disclosure timelines.
- Regulatory Affairs: Ensures compliance with registry and regulatory disclosure requirements.
- QA: Audits publications and disclosures for accuracy and compliance.
Accountability
The Sponsor’s Medical Affairs Head is accountable for ensuring timely publications and regulatory-compliant disclosures. QA is accountable for auditing transparency activities and ensuring inspection readiness.
Procedure
1. Publication Planning
1.1 Develop a Publication Plan outlining target journals, conferences, and timelines.
1.2 Assign authorship according to ICMJE guidelines.
1.3 Maintain Publication Plan Log (Annexure-1).
2. Manuscript and Abstract Development
2.1 Medical writers prepare manuscripts, abstracts, or posters based on CSR data.
2.2 Drafts reviewed by sponsor, investigators, and QA.
2.3 Maintain Draft Review Log (Annexure-2).
3. Disclosure of Trial Results
3.1 Submit results to public registries (ClinicalTrials.gov, EU CTR, WHO ICTRP) within required timelines.
3.2 Prepare lay summaries for participants and public disclosure.
3.3 Record submissions in Results Disclosure Log (Annexure-3).
4. Data Transparency
4.1 Ensure redaction of confidential information before public disclosure.
4.2 Establish process for data sharing with regulators and scientific community.
5. Quality Control and Approvals
5.1 QA performs QC checks on all publications and disclosures.
5.2 Final sponsor sign-off required before public release.
5.3 Maintain Approval Log (Annexure-4).
6. Archiving
6.1 Archive all publications, lay summaries, and disclosure records in TMF.
6.2 Retain documents as per regulatory timelines.
Abbreviations
- SOP: Standard Operating Procedure
- CSR: Clinical Study Report
- QA: Quality Assurance
- CRO: Contract Research Organization
- ICMJE: International Committee of Medical Journal Editors
- TMF: Trial Master File
- WHO: World Health Organization
- EMA: European Medicines Agency
- FDA: Food and Drug Administration
- CDSCO: Central Drugs Standard Control Organization
Documents
- Publication Plan Log (Annexure-1)
- Draft Review Log (Annexure-2)
- Results Disclosure Log (Annexure-3)
- Approval Log (Annexure-4)
References
- ICMJE Recommendations
- ICH E6(R2/R3) – Disclosure and Transparency
- FDA – Transparency in Clinical Trials
- EMA – Publication and Disclosure Policy
- WHO – Transparency in Clinical Trials
- CDSCO – Clinical Trial Disclosure Requirements
Version: 1.0
Approval Section
| Prepared By | Ravi Kumar, Medical Writer |
| Checked By | Sunita Reddy, QA Officer |
| Approved By | Dr. Anil Sharma, Head Medical Affairs |
Annexures
Annexure-1: Publication Plan Log
| Date | Planned Output | Target Journal/Conference | Responsible | Status |
|---|---|---|---|---|
| 01/09/2025 | Manuscript | NEJM | Medical Writer | Planned |
Annexure-2: Draft Review Log
| Date | Document | Reviewer | Comments | Status |
|---|---|---|---|---|
| 10/09/2025 | Manuscript Draft v0.1 | Statistician | Clarify subgroup analysis | Resolved |
Annexure-3: Results Disclosure Log
| Date | Registry | Submission | Submitted By | Status |
|---|---|---|---|---|
| 15/09/2025 | ClinicalTrials.gov | Results Posting | Regulatory Specialist | Completed |
Annexure-4: Approval Log
| Date | Document | Approved By | Decision |
|---|---|---|---|
| 20/09/2025 | Manuscript Draft v1.0 | Head Medical Affairs | Approved |
Revision History
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 26/08/2025 | 00 | Initial version | New SOP creation | Head Medical Affairs |
For more SOPs visit: Pharma SOP