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

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.

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

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

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

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