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
- 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
- Conduct physical examination including:
- Vital signs (BP, pulse, temperature)
- General health and any reported symptoms
- Record findings in Annexure-1: Volunteer Exit Examination Form.
- Assess for any adverse events during the study; document and refer to medical follow-up if needed.
5.3 Laboratory Tests (If Applicable)
- Based on protocol requirements or clinical discretion, perform:
- Post-study hematology/biochemistry
- ECG or urine drug screening
- Record in Annexure-2: Exit Laboratory Report Summary.
5.4 Fitness Certification
- Upon satisfactory examination, the physician shall:
- Certify the subject as “Medically Fit for Discharge”
- Sign Annexure-3: Fitness Certificate
- Subjects not found fit must be retained or referred for further management and documented accordingly.
5.5 Documentation and Volunteer Discharge
- CRC collects signed forms, updates CRF and discharge checklist.
- Subject receives discharge slip and is allowed to leave the facility.
- 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
- Volunteer Exit Examination Form – Annexure-1
- Exit Laboratory Report Summary – Annexure-2
- 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 |