Standard Operating Procedure for Monitoring Compliance of Subject Activities in BA/BE Studies
| Department | BA-BE Studies |
|---|---|
| SOP No. | SOP/BA-BE/097/2025 |
| Supersedes | SOP/BA-BE/097/2022 |
| 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 procedure for monitoring and ensuring compliance of subjects with protocol-defined activities and restrictions during the clinical phase of Bioavailability/Bioequivalence (BA/BE) studies to maintain data integrity and subject safety.
2. Scope
This SOP applies to all clinical personnel responsible for supervising volunteer activities including dietary restrictions, dosing adherence, movement limitations, and post-dose behavioral protocols at the study site.
3. Responsibilities
- Volunteer Coordinator: Informs subjects of activity-related rules and documents acknowledgment.
- Clinical Research Coordinator (CRC): Ensures compliance is monitored and deviations are recorded.
- Study Nurse: Observes activities and reports any deviation from permitted conduct.
- Principal Investigator (PI): Reviews all deviations and determines the impact on study participation.
4. Accountability
The Principal Investigator is accountable for ensuring that subject compliance is monitored and maintained as per protocol and regulatory requirements throughout the clinical phase.
5. Procedure
5.1 Informing Subjects of Compliance Requirements
- At check-in, provide subjects with verbal and written instructions regarding:
- Restricted diet and water intake timings
- Permissible physical activity levels
- Usage of medications, smoking, alcohol, or caffeine
- Mandatory rest or observation periods
- Record acknowledgment on Annexure-1: Subject Compliance Agreement Form.
5.2 Monitoring Subject Behavior
- Assign clinical staff to observe volunteers continuously during the confinement period.
- Log all activities including:
- Time and quantity of meals and water
- Movement within the unit
- Sleep and wake times
- Record observations on Annexure-2: Subject Activity Monitoring Sheet.
5.3 Managing Non-Compliance
- Examples of non-compliance include:
- Eating unauthorized food
- Leaving the designated area without permission
- Using restricted substances
- Document the incident in Annexure-3: Non-Compliance Log and report to PI.
- The PI decides on continuation, withdrawal, or additional monitoring of the subject.
5.4 Re-Training and Documentation
- In case of repeated or critical deviations:
- Provide retraining to the subject
- Document the corrective action taken
6. Abbreviations
- BA: Bioavailability
- BE: Bioequivalence
- CRC: Clinical Research Coordinator
- PI: Principal Investigator
7. Documents
- Subject Compliance Agreement Form – Annexure-1
- Subject Activity Monitoring Sheet – Annexure-2
- Non-Compliance Log – Annexure-3
8. References
- ICH E6(R2) – Good Clinical Practice
- Study Protocol
- Schedule Y – Drugs and Cosmetics Rules
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Subject Compliance Agreement Form
| Subject ID | Date | Informed By | Signature of Subject |
|---|---|---|---|
| VOL-097 | 17/04/2025 | Sunita Reddy | Rajesh Kumar |
Annexure-2: Subject Activity Monitoring Sheet
| Time | Activity Observed | Remarks | Observer |
|---|---|---|---|
| 09:00 AM | Resting in bed | Compliant | Vinay Pawar |
Annexure-3: Non-Compliance Log
| Date | Subject ID | Description | Action Taken | Notified To |
|---|---|---|---|---|
| 17/04/2025 | VOL-097 | Left designated zone | Verbal warning | PI |
Revision History:
| Revision Date | Revision No. | Details | Reason | Approved By |
|---|---|---|---|---|
| 15/01/2022 | 1.0 | Initial Release | New Compliance SOP | QA Head |
| 17/04/2025 | 2.0 | Updated observation and retraining procedures | Audit Recommendation | QA Head |