SOP Guide for Pharma

BA-BE Studies: SOP for Re-Dosing in Cross-Over Study Designs – V 2.0

Auditor

BA-BE Studies: SOP for Re-Dosing in Cross-Over Study Designs – V 2.0

Standard Operating Procedure for Re-Dosing in Cross-Over Study Designs in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/070/2025
Supersedes SOP/BA-BE/070/2022
Page No. Page 1 of 10
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To define a clear and compliant procedure for the re-dosing of participants in cross-over Bioavailability/Bioequivalence (BA/BE) studies, ensuring protocol adherence, subject safety, and regulatory conformity.

2. Scope

This SOP applies to all re-dosing events in cross-over study designs, typically conducted in Period 2 or Period 3 of BA/BE studies, following the washout period. It covers eligibility assessment, safety confirmation, re-dosing administration, and documentation.

3. Responsibilities

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4. Accountability

The Principal Investigator is accountable for ensuring that re-dosing is performed only after confirming protocol compliance, washout completion, subject health status, and documentation readiness.

5. Procedure

5.1 Confirmation of Washout Period

  1. Verify that the washout period defined in the protocol (e.g., 7 days or 5 half-lives) has been completed.
  2. Document washout start and end dates in Annexure-1: Re-Dosing Eligibility Checklist.

5.2 Pre-Re-Dosing Assessment

  1. Conduct:
    • Vital signs check
    • Physical examination
    • Laboratory safety tests (if required)
    • ECG and AE review from previous period
  2. Only subjects with satisfactory medical clearance proceed to re-dosing.

5.3 Subject Consent Confirmation

  1. Reconfirm willingness and eligibility for continued participation.
  2. Ensure that any new risks or AEs are communicated and documented.

5.4 Re-Dosing Procedure

  1. Follow the same dosing process as Period 1:
    • Administer correct formulation (Test or Reference) as per randomization schedule
    • Confirm water volume, fasting/fed status, and supervision
    • Document all entries in Annexure-2: Re-Dosing Record Sheet
See also  BA-BE Studies: SOP for Review of Subject Recruitment Feasibility - V 2.0

5.5 Post-Dose Monitoring

  1. Monitor for AEs, vitals, and protocol-specific parameters.
  2. Record all observations in subject CRFs and Annexure-3: Post Re-Dose Safety Monitoring Log.

5.6 Deviation Handling

  1. Any delay or failure to re-dose as per scheduled window must be documented in Annexure-4: Re-Dosing Deviation Log and escalated to the PI.

6. Abbreviations

7. Documents

  1. Re-Dosing Eligibility Checklist – Annexure-1
  2. Re-Dosing Record Sheet – Annexure-2
  3. Post Re-Dose Safety Monitoring Log – Annexure-3
  4. Re-Dosing Deviation Log – Annexure-4

8. References

9. SOP Version

Version: 2.0

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10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Re-Dosing Eligibility Checklist

Subject ID Washout Period (Days) Vitals Normal Lab Clearance Investigator Approval
VOL-070 8 Yes Yes Approved

Annexure-2: Re-Dosing Record Sheet

Subject ID Date Formulation Dose Time Fasted/Fed Water Volume Dosed By
VOL-070 17/04/2025 Reference 07:05 Fasted 240 mL Dr. Sunita Reddy

Annexure-3: Post Re-Dose Safety Monitoring Log

Subject ID Timepoints Vitals AEs Noted Initials
VOL-070 0.5h, 1h, 2h Normal None R. Pawar

Annexure-4: Re-Dosing Deviation Log

Subject ID Deviation Description Time Action Taken Investigator Review
VOL-070X Dosed 15 min late 07:20 Included, deviation documented Dr. Arvind Shah

Revision History:

Revision Date Revision No. Details Reason Approved By
12/01/2022 1.0 Initial release Study requirement QA Head
17/04/2025 2.0 Added deviation handling and annexures Audit recommendation QA Head
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