Standard Operating Procedure for Handling Confidentiality Agreements with Study Sites in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/035/2025 |
| Supersedes | SOP/BA-BE/035/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To outline the procedure for managing Confidentiality Disclosure Agreements (CDAs) or Non-Disclosure Agreements (NDAs) with clinical study sites in BA/BE studies to ensure that proprietary study information is protected prior to sharing sensitive documents like protocols or clinical trial agreements.
2. Scope
This SOP is applicable to all BA/BE studies involving external clinical trial sites (hospitals, CROs, research institutions) where confidential information must be disclosed prior to study initiation or feasibility discussions.
3. Responsibilities
- Regulatory Affairs: Prepares CDA templates in compliance with applicable laws and company policy.
- Legal Department: Reviews changes or negotiations to the CDA language.
- Clinical Project Manager: Tracks execution status and ensures signed documents are filed correctly.
- Site Representative (Investigator/Administrator): Reviews and signs CDA prior to protocol sharing.
4. Accountability
The Head of Clinical Development is accountable for ensuring that no confidential information is shared with any site unless a valid CDA is fully executed and archived.
5. Procedure
5.1 CDA Template Usage
- Use the organization-approved CDA template (Annexure-1).
- Modify only with approval from Legal Department for each instance.
5.2 CDA Issuance
- Send CDA to the prospective site electronically.
- Include covering email explaining the scope and requesting signature within a specified timeline (e.g., 5 working days).
- Track issuance in Annexure-2: CDA Tracking Log.
5.3 Negotiation and Finalization
- All redlines or edits by site must be reviewed by Legal Department.
- Negotiate terms only through Regulatory or Legal contact points.
- Once mutually agreed, obtain signed copies from both parties.
5.4 Record Maintenance
- Store scanned copies of signed CDAs in the Trial Master File (TMF) and CDA Repository Folder.
- Update status in CDA Tracking Log with date and version signed.
- If multiple sites are involved, maintain site-wise records with folder structure per study ID.
5.5 Expiry and Renewals
- CDAs typically remain in effect for 2–5 years or as specified in the agreement.
- Track expiration and initiate renewal 1 month prior to expiry if continued engagement is expected.
6. Abbreviations
- CDA: Confidentiality Disclosure Agreement
- NDA: Non-Disclosure Agreement
- TMF: Trial Master File
- RA: Regulatory Affairs
7. Documents
- Standard CDA Template – Annexure-1
- CDA Tracking Log – Annexure-2
8. References
- ICH E6(R2) – Good Clinical Practice
- EU GDPR – Data Protection Regulation
- Organization’s Data Privacy and Legal Policy
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Standard CDA Template
| Clause | Description |
|---|---|
| Confidential Information | All non-public data shared for the purpose of study initiation |
| Term | Valid for 3 years unless otherwise specified |
| Obligations | No unauthorized sharing, copying, or use beyond purpose |
Annexure-2: CDA Tracking Log
| Site Name | Study Code | Date Sent | Date Signed | Status | Remarks |
|---|---|---|---|---|---|
| MedTech Hospital | BE-042 | 10/04/2025 | 14/04/2025 | Executed | Filed in TMF |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 12/01/2022 | 1.0 | Initial SOP | New documentation policy | QA Head |
| 17/04/2025 | 2.0 | Included CDA repository and expiration tracking | Regulatory compliance | QA Head |