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

Clinical Research Coordinator (CRC): Ensures all post-dosing procedures are implemented and documented as per protocol.
Study Nurse: Monitors vital signs and adverse events at scheduled intervals.
Principal Investigator (PI): Oversees clinical safety and reviews post-dose observation logs.
Volunteer Coordinator: Informs volunteers of restrictions and ensures compliance.

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

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
Document instruction delivery in Annexure-1: Volunteer Post-Dose Restriction Log.

5.2 Observation Timepoints and Parameters

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
Record observations in Annexure-2: Post-Dosing Observation Sheet.

5.3 Restriction Compliance Monitoring

Assign staff to monitor subjects for:
- Unauthorized food or fluid intake
- Unauthorized movement or leaving the designated area
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

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

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

6. Abbreviations

BA: Bioavailability
BE: Bioequivalence
CRC: Clinical Research Coordinator
PI: Principal Investigator
CRF: Case Report Form
AE: Adverse Event

7. Documents

Volunteer Post-Dose Restriction Log – Annexure-1
Post-Dosing Observation Sheet – Annexure-2
Deviation and Non-Compliance Log – Annexure-3

8. References

ICH E6(R2) – Good Clinical Practice
Indian GCP Guidelines
Study Protocol

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