Standard Operating Procedure for Subject Enrolment and Randomization Process in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/052/2025 |
| Supersedes | SOP/BA-BE/052/2022 |
| Page No. | Page 1 of 11 |
| Issue Date | 17/04/2025 |
| Effective Date | 20/04/2025 |
| Review Date | 17/04/2026 |
1. Purpose
To define the procedure for enrolling eligible subjects and allocating them to treatment sequences using a pre-approved and validated randomization process in Bioavailability/Bioequivalence (BA/BE) studies.
2. Scope
This SOP applies to all clinical trials conducted under BA/BE protocols where subject enrolment and randomization are required for assignment into study arms or dosing sequences (e.g., crossover designs).
3. Responsibilities
- Clinical Research Coordinator: Maintains enrolment log, verifies eligibility, and documents subject inclusion.
- Biostatistician: Prepares and validates the randomization code and ensures concealment of allocation.
- Principal Investigator (PI): Authorizes final enrolment and confirms randomization sequence adherence.
4. Accountability
The Study PI is accountable for ensuring that subject selection, enrolment, and randomization comply with the protocol, GCP, and applicable regulatory requirements.
5. Procedure
5.1 Enrolment Criteria Confirmation
- Review final screening data and confirm subject eligibility using Annexure-1: Final Eligibility Verification Form.
- Verify that informed consent has been obtained and documented properly.
5.2 Subject Enrolment
- Assign a unique Subject ID (SID) to each eligible subject using a sequential identifier format (e.g., BE-052-001).
- Record subject details in the Subject Enrolment Log (Annexure-2).
- Enroll only the number of subjects as approved in the protocol and Ethics Committee approval letter.
5.3 Randomization Process
- Obtain the pre-generated randomization schedule from the study statistician.
- Randomization code should be blinded from the clinical team (in case of blinded trials).
- Assign treatment sequences using Annexure-3: Randomization Allocation Log.
- Ensure balanced distribution across sequences for crossover studies (e.g., AB, BA, etc.).
5.4 Documentation and Security
- Maintain a copy of the signed randomization list in the Trial Master File (TMF).
- Secure randomization documents in a restricted-access area.
- Do not allow any modifications to the randomization list post finalization.
5.5 Replacement of Subjects (If Applicable)
- Use predefined criteria for subject replacement (e.g., subject withdrawal, protocol deviation).
- Assign next available SID and randomization number if permitted by protocol.
- Document the reason for replacement in Annexure-4: Subject Replacement Tracker.
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- SID: Subject Identification Number
- PI: Principal Investigator
- TMF: Trial Master File
7. Documents
- Final Eligibility Verification Form – Annexure-1
- Subject Enrolment Log – Annexure-2
- Randomization Allocation Log – Annexure-3
- Subject Replacement Tracker – Annexure-4
8. References
- ICH E6(R2) – Good Clinical Practice
- CDSCO Guidelines for BA/BE Studies
- EMA Guideline on the Investigation of Bioequivalence
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Final Eligibility Verification Form
| Subject ID | Eligibility Criteria Met | Verified By | Date |
|---|---|---|---|
| BE-052-001 | Yes | Dr. Arvind Shah | 15/04/2025 |
Annexure-2: Subject Enrolment Log
| Subject ID | Name | Gender | Age | Date of Enrolment |
|---|---|---|---|---|
| BE-052-001 | Ajay Verma | Male | 27 | 15/04/2025 |
Annexure-3: Randomization Allocation Log
| Subject ID | Sequence | Period 1 | Period 2 |
|---|---|---|---|
| BE-052-001 | AB | Test | Reference |
Annexure-4: Subject Replacement Tracker
| Original Subject ID | Reason for Replacement | New Subject ID | Date | Remarks |
|---|---|---|---|---|
| BE-052-005 | Withdrew Consent | BE-052-021 | 16/04/2025 | Replaced as per protocol |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 10/01/2022 | 1.0 | Initial version | New SOP implementation | QA Head |
| 17/04/2025 | 2.0 | Updated annexures and aligned with crossover studies | Regulatory harmonization | QA Head |