Standard Operating Procedure for Study Initiation Checklist in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/031/2025 |
| Supersedes | SOP/BA-BE/031/2022 |
| 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 a standardized procedure for the creation and use of a Study Initiation Checklist that ensures all regulatory, administrative, logistical, and operational activities are completed prior to the initiation of a Bioavailability/Bioequivalence (BA/BE) clinical study.
2. Scope
This SOP applies to all BA/BE studies managed or sponsored by the organization and is to be followed by study teams, investigators, clinical operations, and regulatory personnel prior to first subject enrollment.
3. Responsibilities
- Clinical Project Manager: Oversees completion and documentation of the checklist.
- Site Coordinator/CRA: Verifies and updates site-specific readiness.
- Regulatory Affairs: Confirms submission and approval statuses.
- QA/Compliance Team: Ensures checklist documentation is auditable and complete.
4. Accountability
The Head of Clinical Operations is accountable for ensuring that no BA/BE study begins without a fully completed and approved Study Initiation Checklist on file.
5. Procedure
5.1 Checklist Preparation
- Use the standardized template from Annexure-1: Study Initiation Checklist Template.
- Customize checklist fields for the specific protocol/study based on sponsor and regulatory requirements.
5.2 Key Elements of the Checklist
- The checklist must include verification of:
- Final Protocol Approval
- Ethics Committee Approval Letter
- Informed Consent Forms (all versions and languages)
- Signed Clinical Trial Agreement
- Insurance Coverage Document
- Site Staff Training Certificates (Protocol & GCP)
- Reference Product Procurement Status
- Randomization Schedule Availability
- Clinical Trial Supplies (Kits, Labels, CRFs)
- Drug Storage and Calibration Records
- Readiness of Pharmacokinetic Sample Handling Area
- Medical Emergency SOP and Equipment Availability
5.3 Checklist Completion and Approval
- Each item in the checklist must be signed and dated by the responsible team member.
- CRA verifies checklist accuracy during Site Initiation Visit (SIV).
- Clinical Project Manager signs off and files the checklist in the TMF/eTMF using Annexure-2: Study Initiation Completion Log.
5.4 Filing and Archiving
- Completed checklist to be filed in both physical and electronic format.
- Checklist must be accessible for audits, inspections, and internal reviews.
6. Abbreviations
- SIV: Site Initiation Visit
- CRA: Clinical Research Associate
- CRF: Case Report Form
- GCP: Good Clinical Practice
- TMF: Trial Master File
7. Documents
- Study Initiation Checklist Template – Annexure-1
- Study Initiation Completion Log – Annexure-2
8. References
- ICH E6(R2) – Good Clinical Practice
- Schedule Y – Drugs and Cosmetics Rules
- CDSCO Guidelines on Clinical Trials
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 Initiation Checklist Template
| Checklist Item | Completed By | Date | Remarks |
|---|---|---|---|
| Final Protocol Signed | Rajesh Kumar | 14/04/2025 | V2.0 |
| EC Approval Received | Sunita Reddy | 15/04/2025 | Received on time |
Annexure-2: Study Initiation Completion Log
| Study Code | Site Code | Date of Completion | Verified By | Remarks |
|---|---|---|---|---|
| BE-038 | Site-102 | 17/04/2025 | CRA | Ready for FPFV |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 14/01/2022 | 1.0 | Initial SOP | New implementation | QA Head |
| 17/04/2025 | 2.0 | Added site readiness elements, annexures | Operational update | QA Head |