Standard Operating Procedure for Ongoing Medical Surveillance of Subjects in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/146/2025
Supersedes	SOP/BA-BE/146/2022
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 systematic approach for the ongoing medical surveillance of healthy volunteers participating in BA/BE studies to monitor their health status, ensure early detection of adverse events, and support protocol compliance.

2. Scope

This SOP applies to all clinical staff, including physicians, nurses, and coordinators, involved in the monitoring and care of subjects during the conduct of BA/BE trials from admission to final follow-up.

3. Responsibilities

• Medical Officer: Perform routine clinical evaluations, document findings, and escalate medical issues promptly.
• Nursing Staff: Record vital signs, observe clinical changes, and report abnormalities to the Medical Officer.
• Study Coordinator: Ensure appropriate documentation and adherence to surveillance schedule.
• Principal Investigator (PI): Oversee medical management and subject well-being during study.

4. Accountability

The Clinical Unit Head is accountable for ensuring that all surveillance procedures are implemented effectively and any deviation is addressed through appropriate corrective measures.

5. Procedure

5.1 Pre-Dosing Surveillance

1. Ensure that each subject undergoes:
   • Medical history review
   • Physical examination
   • Vital signs assessment (BP, pulse, temperature, respiratory rate)
   • ECG and lab reports (if applicable)
2. Review findings and certify fitness for dosing in Annexure-1: Pre-Dose Medical Surveillance Log.

5.2 Dosing Day Surveillance

1. On the day of dosing:
   • Monitor fasting status of each subject
   • Reassess vitals 30 minutes prior to dosing
   • Record any last-minute medical complaints
2. Post-dosing:
   • Vitals at 1, 2, 4, 8, and 12 hours post-dose (or as per protocol)
   • Clinical staff to observe for symptoms like dizziness, nausea, rash, or discomfort
   • Document all observations in Annexure-2: Dosing Day Surveillance Chart

5.3 Residential Period Surveillance

1. Conduct thrice-daily vitals checks (morning, afternoon, evening)
2. Subjects to be asked about any discomfort, adverse symptoms, or sleep issues
3. Monitor intake and output (food, water, urine) and document in Annexure-3: Daily Medical Monitoring Sheet

5.4 Post-Dosing and Follow-Up Surveillance

1. On study exit:
   • Perform exit medical evaluation
   • Conduct pregnancy test (if applicable)
   • Assess and document subject fitness to leave facility
2. During follow-up:
   • Collect lab samples as per protocol
   • Check for delayed adverse reactions
   • Record in Annexure-4: Follow-Up Medical Surveillance Log

5.5 Adverse Event (AE) Monitoring

1. All AEs reported by subjects or detected during exams must be:
   • Evaluated for severity and causality
   • Documented in AE forms and Annexure-5: AE/SAE Surveillance Log
   • Reported to Ethics Committee and sponsor (if required)

5.6 Medical Staff Deployment

1. Ensure 24×7 availability of registered medical staff at the clinical site
2. On-call physician must be reachable during outpatient follow-up hours
3. Shift roster should be recorded in Annexure-6: Medical Duty Roster

5.7 Emergency Preparedness

1. Emergency cart to be available and fully stocked during all study periods
2. CPR-trained staff must be on-site during dosing and intensive surveillance windows
3. Mock drills to be conducted quarterly and logged

6. Abbreviations

• BA/BE: Bioavailability/Bioequivalence
• PI: Principal Investigator
• ECG: Electrocardiogram
• AE: Adverse Event
• SAE: Serious Adverse Event

7. Documents

1. Pre-Dose Medical Surveillance Log – Annexure-1
2. Dosing Day Surveillance Chart – Annexure-2
3. Daily Medical Monitoring Sheet – Annexure-3
4. Follow-Up Medical Surveillance Log – Annexure-4
5. AE/SAE Surveillance Log – Annexure-5
6. Medical Duty Roster – Annexure-6

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules, India
• WHO Guidelines for Clinical Trials

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Pre-Dose Medical Surveillance Log

Subject ID	Date	Vitals Normal	Complaints	Physician Comments
VOL1025	15/04/2025	Yes	None	Fit for dosing

Annexure-2: Dosing Day Surveillance Chart

Subject ID	Time	Vitals (BP/HR/Temp)	Observations	Initials
VOL1025	2h Post-dose	120/78, 72, 36.8°C	No complaints	NV

Annexure-3: Daily Medical Monitoring Sheet

Date	Subject ID	Morning	Afternoon	Evening	Remarks
16/04/2025	VOL1025	Stable	Stable	Stable	None

Annexure-4: Follow-Up Medical Surveillance Log

Subject ID	Date	Visit Type	Vitals	Medical Issues
VOL1025	22/04/2025	Follow-Up	Normal	None

Annexure-5: AE/SAE Surveillance Log

Date	Subject ID	Event	Severity	Outcome
16/04/2025	VOL1025	Nausea	Mild	Resolved

Annexure-6: Medical Duty Roster

Date	Shift	Doctor Name	Contact
15/04/2025	Day	Dr. Sunita Reddy	9876543210

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
01/01/2022	1.0	Initial release	New SOP	QA Head
17/04/2025	2.0	Expanded procedure and added annexures	Audit and GCP alignment	QA Head