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Standard Operating Procedure for Publication Policy and Disclosure/Transparency

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 regulatory agencies, investigators, participants, and the public while meeting global regulatory and ethical requirements.

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

1. Publication Plan Log (Annexure-1)
2. Draft Review Log (Annexure-2)
3. Results Disclosure Log (Annexure-3)
4. 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

Annexures

Annexure-1: Publication Plan Log

Annexure-2: Draft Review Log

Annexure-3: Results Disclosure Log

Annexure-4: Approval Log

Revision History

For more SOPs visit: Pharma SOP

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Standard Operating Procedure for Sample Shipment and Chain of Custody

Purpose

The purpose of this SOP is to establish standardized procedures for the shipment of biological samples in clinical trials, ensuring integrity, confidentiality, and compliance with international guidelines such as ICH GCP, FDA, EMA, CDSCO, WHO, and IATA Dangerous Goods Regulations.

Scope

This SOP applies to all clinical trial personnel, including investigators, laboratory staff, couriers, and CROs involved in sample packaging, shipment, transport, and receipt. It covers temperature-controlled shipments, dry ice packaging, courier qualification, chain of custody documentation, and deviation handling.

Responsibilities

• Investigator: Ensures compliance with protocol requirements for sample shipment.
• Clinical Staff: Prepares, packages, and documents samples before shipment.
• Courier: Transports samples under validated, compliant conditions.
• Laboratory Staff: Verify receipt and integrity of samples upon arrival.
• CRA: Reviews shipment documentation during monitoring visits.
• QA: Audits shipment records and chain of custody compliance.

Accountability

The Sponsor is accountable for oversight of sample shipment procedures and vendor qualification. The Investigator is accountable for accurate pre-shipment documentation and chain of custody. QA is accountable for ensuring compliance with applicable regulations.

Procedure

1. Courier Qualification
1.1 Only couriers qualified and audited for biological sample handling may be used.
1.2 Maintain Vendor Qualification File with certificates and audits.

2. Packaging
2.1 Follow IATA Packing Instruction 650 for biological substances (Category B).
2.2 Use triple-layer packaging (primary container, secondary leak-proof container, outer package).
2.3 Label packages with “Biological Substance, Category B” and dry ice details (if applicable).

3. Pre-Shipment Documentation
3.1 Complete Sample Shipment Form (Annexure-1) for each shipment.
3.2 Document temperature monitoring devices inside packages.
3.3 Investigator or delegated staff signs Chain of Custody Log (Annexure-2).

4. Transport
4.1 Couriers must maintain specified temperature ranges (e.g., 2–8°C, −20°C, −80°C).
4.2 Couriers record each transfer point in the Chain of Custody Log.
4.3 Any delays or incidents must be documented in Shipment Deviation Log (Annexure-3).

5. Receipt of Samples
5.1 Laboratory staff verify integrity, labeling, and temperature conditions.
5.2 Document receipt in Sample Receipt Log (Annexure-4).
5.3 Notify Sponsor/Investigator immediately in case of discrepancies.

6. Chain of Custody
6.1 Maintain uninterrupted custody from collection site to laboratory.
6.2 All handovers must be signed, dated, and recorded.
6.3 QA verifies chain of custody completeness during audits.

7. Deviations
7.1 Record deviations (e.g., temperature excursion, courier delays) in Shipment Deviation Log.
7.2 Investigate deviations and initiate CAPA.

Abbreviations

• SOP: Standard Operating Procedure
• CRA: Clinical Research Associate
• QA: Quality Assurance
• CRO: Contract Research Organization
• IATA: International Air Transport Association
• CAPA: Corrective and Preventive Action

Documents

1. Sample Shipment Form (Annexure-1)
2. Chain of Custody Log (Annexure-2)
3. Shipment Deviation Log (Annexure-3)
4. Sample Receipt Log (Annexure-4)

References

• ICH E6(R2/R3) – Sample Handling and Transport
• FDA – Biospecimen Transport Guidance
• EMA – Clinical Trial Sample Shipment Requirements
• CDSCO – Biological Sample Handling
• WHO – Biospecimen Transport and Chain of Custody

Version: 1.0

Approval Section

Annexures

Annexure-1: Sample Shipment Form

Annexure-2: Chain of Custody Log

Annexure-3: Shipment Deviation Log

Annexure-4: Sample Receipt Log

Revision History

For more SOPs visit: Pharma SOP