Standard Operating Procedure for Medical History Documentation in Healthy Volunteers for BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/053/2025
Supersedes	SOP/BA-BE/053/2022
Page No.	Page 1 of 10
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define a standardized procedure for documenting the past and present medical history of healthy volunteers in Bioavailability/Bioequivalence (BA/BE) studies, to support proper eligibility assessment and ensure subject safety.

2. Scope

This SOP applies to all volunteers undergoing medical screening for participation in BA/BE studies at the clinical research facility, specifically focusing on the structured documentation of medical history during the screening phase.

3. Responsibilities

• Screening Physician: Conducts interview and validates all medical history information provided by the volunteer.
• Clinical Research Coordinator: Ensures proper forms are completed, signed, and archived in the subject’s screening file.

4. Accountability

The Principal Investigator is accountable for the review and approval of each subject’s documented medical history prior to determining eligibility.

5. Procedure

5.1 Preparation

1. Ensure that the volunteer has signed the screening informed consent form before beginning the medical history documentation.
2. Use the standardized Annexure-1: Medical History Questionnaire for structured data capture.

5.2 Conduct of Medical History Interview

1. The Screening Physician shall interview the subject in a private setting.
2. Ask open-ended questions to capture details regarding:
   • Any chronic or past illnesses (e.g., asthma, diabetes, hypertension)
   • History of surgeries or hospitalizations
   • Use of medications, supplements, or herbal products in the last 3 months
   • Known allergies (e.g., drug, food, environmental)
   • Substance use (smoking, alcohol, narcotics)
   • Vaccination history or recent infections

5.3 Documentation

1. Record each detail accurately in Annexure-1 with Yes/No format and provide brief remarks if “Yes.”
2. Mark items as “Not Known” only when subject is unsure and the data cannot be verified.
3. Ensure all fields are filled, signed, and dated by the Screening Physician and the subject.

5.4 Review and Finalization

1. Physician must evaluate whether any reported condition affects subject eligibility based on protocol-defined criteria.
2. Highlight any medically significant findings and document the final assessment in Annexure-2: Physician’s Summary and Opinion.

5.5 Filing and Storage

1. File completed and signed forms in the subject’s screening folder.
2. Ensure all documents are securely stored and retrievable as part of GCP compliance.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• GCP: Good Clinical Practice

7. Documents

1. Medical History Questionnaire – Annexure-1
2. Physician’s Summary and Opinion – Annexure-2

8. References

• ICH E6(R2) – Good Clinical Practice
• CDSCO Guidelines for BA/BE Studies
• WHO Handbook on Good Clinical Research Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Medical History Questionnaire

Condition	Yes/No	Details (if Yes)
Diabetes	No	–
Allergies	Yes	Paracetamol
Past Surgery	No	–

Annexure-2: Physician’s Summary and Opinion

Volunteer ID	Summary of Findings	Is Subject Eligible?	Physician Signature	Date
VOL-053	Minor drug allergy (non-serious)	Yes	Dr. Sunita Reddy	15/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial Release	GCP Compliance	QA Head
17/04/2025	2.0	Annexures and summary form added	Operational Streamlining	QA Head