SOP Guide for Pharma

BA-BE Studies: SOP for Post-Dosing Restrictions and Observations – V 2.0

Auditor

BA-BE Studies: SOP for Post-Dosing Restrictions and Observations – V 2.0

Standard Operating Procedure for Post-Dosing Restrictions and Observations in BA/BE Studies

Department BA-BE Studies
SOP No. SOP/BA-BE/093/2025
Supersedes SOP/BA-BE/093/2022
Page No. Page 1 of 10
Issue Date 17/04/2025
Effective Date 20/04/2025
Review Date 17/04/2026

1. Purpose

To establish a uniform procedure for enforcing post-dosing restrictions and conducting medical observations of volunteers during the clinical phase of BA/BE studies, ensuring subject safety and compliance with study protocol and regulatory expectations.

2. Scope

This SOP applies to all clinical research personnel involved in volunteer supervision, observation, and enforcement of behavioral or dietary restrictions after dosing in BA/BE studies.

3. Responsibilities

See also  BA-BE Studies: SOP for Contingency Plan for Power or Equipment Failure - V 2.0

4. Accountability

The Study Director is accountable for ensuring that all post-dosing restrictions and monitoring procedures are followed as per study protocol, ICH-GCP, and Schedule Y requirements.

5. Procedure

5.1 Volunteer Instructions Post-Dosing

  1. Immediately after dosing, inform each volunteer about:
    • Dietary restrictions (no food for a defined period)
    • Water restriction (typically 1 hour post-dose unless protocol specifies otherwise)
    • No physical exertion or strenuous activity
    • Remaining in bed or sitting unless permitted
  2. Document instruction delivery in Annexure-1: Volunteer Post-Dose Restriction Log.

5.2 Observation Timepoints and Parameters

  1. Monitor the following at defined intervals:
    • Vital signs (BP, pulse, respiration, temperature)
    • Level of consciousness
    • Presence of adverse events such as nausea, dizziness, or vomiting
  2. Record observations in Annexure-2: Post-Dosing Observation Sheet.
See also  BA-BE Studies: SOP for Interim Clinical Monitoring Reports - V 2.0

5.3 Restriction Compliance Monitoring

  1. Assign staff to monitor subjects for:
    • Unauthorized food or fluid intake
    • Unauthorized movement or leaving the designated area
  2. Any non-compliance should be documented in Annexure-3: Deviation and Non-Compliance Log and reported to PI.

5.4 Management of Symptoms and Adverse Events

  1. If any symptom is observed:
    • Inform the study physician immediately
    • Administer necessary treatment
    • Document in AE log and include in CRF

5.5 Post-Restriction Reassessment

  1. After the restriction window (e.g., 4 hours), reassess vitals and general health status.
  2. Allow food and water only after clearance by study physician.
  3. Document time and type of first post-restriction meal and fluids.

6. Abbreviations

7. Documents

  1. Volunteer Post-Dose Restriction Log – Annexure-1
  2. Post-Dosing Observation Sheet – Annexure-2
  3. Deviation and Non-Compliance Log – Annexure-3
See also  BA-BE Studies: SOP for Clinical Trial Facility Cleaning and Hygiene - V 2.0

8. References

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Volunteer Post-Dose Restriction Log

Subject ID Date Time Restriction Informed Informed By Volunteer Signature
VOL-093 17/04/2025 08:05 AM Sunita Reddy Rajesh Kumar

Annexure-2: Post-Dosing Observation Sheet

Time BP Pulse Temp Symptoms Observed Remarks
09:00 AM 120/78 72 36.5°C None Stable

Annexure-3: Deviation and Non-Compliance Log

Date Subject ID Deviation Action Taken Reported To
17/04/2025 VOL-093 Consumed water early Counselled PI & QA

Revision History:

Revision Date Revision No. Details Reason Approved By
10/01/2022 1.0 Initial Release Protocol Requirement QA Head
17/04/2025 2.0 Added Annexures and clarified observation intervals Audit Suggestion QA Head
Exit mobile version