Standard Operating Procedure for Exit Examination of Volunteers in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/084/2025
Supersedes	SOP/BA-BE/084/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a uniform and compliant procedure for conducting exit examinations of study volunteers at the end of each period or study completion in Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP applies to all volunteers participating in BA/BE studies conducted at clinical research facilities, and to the medical personnel conducting post-study medical evaluations prior to discharge.

3. Responsibilities

• Clinical Research Physician: Conducts physical and clinical assessments at exit.
• CRC: Coordinates subject flow, maintains records, and ensures form completion.
• Volunteer Coordinator: Assists in escorting subjects and verifying identity during examination.

4. Accountability

The Principal Investigator is accountable for ensuring that exit examinations are performed and documented before subjects are discharged from the study site.

5. Procedure

5.1 Eligibility for Exit Examination

1. Volunteers are eligible for exit examination:
   • After completion of all pharmacokinetic blood draws
   • Following post-dose observation period and safety monitoring

5.2 Medical Assessment at Exit

1. Conduct physical examination including:
   • Vital signs (BP, pulse, temperature)
   • General health and any reported symptoms
2. Record findings in Annexure-1: Volunteer Exit Examination Form.
3. Assess for any adverse events during the study; document and refer to medical follow-up if needed.

5.3 Laboratory Tests (If Applicable)

1. Based on protocol requirements or clinical discretion, perform:
   • Post-study hematology/biochemistry
   • ECG or urine drug screening
2. Record in Annexure-2: Exit Laboratory Report Summary.

5.4 Fitness Certification

1. Upon satisfactory examination, the physician shall:
   • Certify the subject as “Medically Fit for Discharge”
   • Sign Annexure-3: Fitness Certificate
2. Subjects not found fit must be retained or referred for further management and documented accordingly.

5.5 Documentation and Volunteer Discharge

1. CRC collects signed forms, updates CRF and discharge checklist.
2. Subject receives discharge slip and is allowed to leave the facility.
3. Maintain copies of all documents in the Trial Master File (TMF).

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• CRF: Case Report Form
• TMF: Trial Master File

7. Documents

1. Volunteer Exit Examination Form – Annexure-1
2. Exit Laboratory Report Summary – Annexure-2
3. Fitness Certificate – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs & Cosmetics Rules, India
• 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 Exit Examination Form

Subject ID	BP	Pulse	Temp	Symptoms	Physician Signature
VOL-084	118/78	74	36.6°C	None	Dr. A. Shah

Annexure-2: Exit Laboratory Report Summary

Subject ID	Test Type	Date	Result Summary	Remarks
VOL-084	Hematology	17/04/2025	Normal	Cleared

Annexure-3: Fitness Certificate

Subject ID	Date	Status	Physician	Remarks
VOL-084	17/04/2025	Medically Fit	Dr. Arvind Shah	Discharged

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial Release	Study compliance	QA Head
17/04/2025	2.0	Included laboratory tests and fitness certificate annexures	Audit feedback	QA Head