SOP Guide for Pharma

BA-BE Studies: SOP for Subject Enrolment and Randomization Process – V 2.0

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BA-BE Studies: SOP for Subject Enrolment and Randomization Process – V 2.0

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

See also  BA-BE Studies: SOP for Review of Regulatory Guidelines before Study Start - V 2.0

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

  1. Review final screening data and confirm subject eligibility using Annexure-1: Final Eligibility Verification Form.
  2. Verify that informed consent has been obtained and documented properly.

5.2 Subject Enrolment

  1. Assign a unique Subject ID (SID) to each eligible subject using a sequential identifier format (e.g., BE-052-001).
  2. Record subject details in the Subject Enrolment Log (Annexure-2).
  3. Enroll only the number of subjects as approved in the protocol and Ethics Committee approval letter.

5.3 Randomization Process

  1. Obtain the pre-generated randomization schedule from the study statistician.
  2. Randomization code should be blinded from the clinical team (in case of blinded trials).
  3. Assign treatment sequences using Annexure-3: Randomization Allocation Log.
  4. Ensure balanced distribution across sequences for crossover studies (e.g., AB, BA, etc.).
See also  BA-BE Studies: SOP for Preparing Clinical Investigator’s Brochure (CIB) - V 2.0

5.4 Documentation and Security

  1. Maintain a copy of the signed randomization list in the Trial Master File (TMF).
  2. Secure randomization documents in a restricted-access area.
  3. Do not allow any modifications to the randomization list post finalization.

5.5 Replacement of Subjects (If Applicable)

  1. Use predefined criteria for subject replacement (e.g., subject withdrawal, protocol deviation).
  2. Assign next available SID and randomization number if permitted by protocol.
  3. Document the reason for replacement in Annexure-4: Subject Replacement Tracker.

6. Abbreviations

7. Documents

  1. Final Eligibility Verification Form – Annexure-1
  2. Subject Enrolment Log – Annexure-2
  3. Randomization Allocation Log – Annexure-3
  4. Subject Replacement Tracker – Annexure-4

8. References

See also  BA-BE Studies: SOP for Handling Expired Reference Products - V 2.0

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
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