Standard Operating Procedure for Clinical Trial Budget Preparation and Approvals in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/038/2025 |
| Supersedes | SOP/BA-BE/038/2022 |
| Page No. | Page 1 of 13 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for preparing and obtaining approval for the clinical trial budget associated with Bioavailability/Bioequivalence (BA/BE) studies, including cost estimation, review, negotiation, finalization, and documentation.
2. Scope
This SOP applies to all BA/BE studies conducted or sponsored by the organization and covers budgeting activities for internal resources, site payments, CRO services, laboratory testing, volunteer reimbursements, and contingency funds.
3. Responsibilities
- Clinical Project Manager: Initiates and prepares the draft study budget in consultation with relevant departments.
- Finance Department: Verifies financial projections, vendor rates, and payment timelines.
- Regulatory Affairs: Confirms budget covers all submission and approval fees.
- Site Management Team: Coordinates site budget negotiation and obtains approval from the Principal Investigator.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that each BA/BE study has a finalized and approved budget in place before the initiation of any contractual commitments or clinical activities.
5. Procedure
5.1 Budget Planning Initiation
- Initiate budget planning during protocol development or feasibility stage.
- Use Annexure-1: Clinical Trial Budget Template to list all anticipated line items.
5.2 Cost Components to be Included
- Include the following cost elements:
- Site fees (screening, randomization, completion)
- Volunteer compensation and meals
- Clinical supplies and lab kits
- Bioanalytical sample analysis
- Regulatory and EC submission fees
- Insurance premiums
- CRO/vendor fees
- Monitoring travel and overheads
- Archival and TMF maintenance
- Contingency (5–10%)
5.3 Internal Review and Revisions
- Circulate draft budget internally for review using Annexure-2: Budget Review Log.
- Revise based on feedback from functional teams.
5.4 Site and Vendor Budget Negotiation
- Share budget breakdown with site and CRO for review.
- Negotiate line items where required and document changes in Annexure-3: Negotiation Summary Sheet.
5.5 Final Approval and Execution
- Compile finalized budget with signatures using Annexure-4: Final Budget Approval Form.
- Store all budget documents in the Trial Master File (TMF).
- Use approved budget as baseline for future cost tracking and reconciliation.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRO: Contract Research Organization
- EC: Ethics Committee
- TMF: Trial Master File
7. Documents
- Clinical Trial Budget Template – Annexure-1
- Budget Review Log – Annexure-2
- Negotiation Summary Sheet – Annexure-3
- Final Budget Approval Form – Annexure-4
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- Internal Clinical Study Finance SOP
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Clinical Trial Budget Template
| Cost Component | Estimated Amount (INR) | Remarks |
|---|---|---|
| Volunteer Compensation | ₹2,00,000 | Includes meals & travel |
| Site Management Fees | ₹3,00,000 | Per subject cost |
Annexure-2: Budget Review Log
| Reviewer | Department | Date | Comments | Status |
|---|---|---|---|---|
| Sunita Reddy | QA | 12/04/2025 | Add contingency reserve | Incorporated |
Annexure-3: Negotiation Summary Sheet
| Item | Original Quote | Final Agreed | Justification |
|---|---|---|---|
| Bioanalytical Testing | ₹4,50,000 | ₹4,00,000 | Volume-based discount |
Annexure-4: Final Budget Approval Form
| Study Code | Total Budget | Approved By | Date | Signature |
|---|---|---|---|---|
| BE-043 | ₹12,80,000 | Dr. Arvind Shah | 17/04/2025 |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial SOP | New budget control process | QA Head |
| 17/04/2025 | 2.0 | Added annexures and CRO cost tracking | Financial compliance | QA Head |