Standard Operating Procedure for Physical Examination Prior to Dosing in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/055/2025
Supersedes	SOP/BA-BE/055/2022
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 the procedure for conducting a standardized physical examination of healthy volunteers prior to administration of investigational or reference products in Bioavailability/Bioequivalence (BA/BE) studies, ensuring the subject is clinically fit for dosing.

2. Scope

This SOP applies to all clinical staff responsible for pre-dose physical evaluations of study participants enrolled in BA/BE studies at the clinical site.

3. Responsibilities

• Investigator/Sub-Investigator: Performs the physical examination and determines subject fitness prior to dosing.
• Clinical Research Coordinator: Ensures subject is available as per schedule and assists with documentation.

4. Accountability

The Principal Investigator is accountable for ensuring that the physical examination is performed and documented for each subject before dosing begins.

5. Procedure

5.1 Preparation

1. Ensure that the volunteer has cleared all pre-dose assessments such as laboratory results, ECG, and medical history.
2. Use Annexure-1: Pre-Dose Physical Examination Form for each subject.

5.2 Timing of Examination

1. Conduct physical examination within 24 hours prior to drug administration.
2. Ensure the examination is conducted in a designated examination area under privacy-compliant conditions.

5.3 Examination Parameters

1. Check and record the following:
   • Height (only if not previously documented)
   • Weight (to verify dosing eligibility)
   • Vital Signs: Temperature, Blood Pressure, Pulse Rate, Respiratory Rate
   • General Appearance
   • Systemic Examination:
     • Cardiovascular
     • Respiratory
     • Abdomen
     • Central Nervous System (CNS)
     • Skin and visible mucosa

5.4 Assessment of Dosing Fitness

1. If the subject shows no clinical abnormalities, mark as “Fit for Dosing.”
2. If any abnormal findings are noted, consult PI for decision on subject continuation.
3. Record decision in Annexure-1 under final assessment section.

5.5 Documentation

1. Ensure the form is signed by the examining physician and dated.
2. Attach the completed form to the subject’s clinical trial folder.
3. Document the outcome in Annexure-2: Pre-Dose Examination Summary Log.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• CNS: Central Nervous System

7. Documents

1. Pre-Dose Physical Examination Form – Annexure-1
2. Pre-Dose Examination Summary Log – Annexure-2

8. References

• ICH E6(R2) – Good Clinical Practice
• CDSCO BA/BE Guidelines
• WHO GCP Handbook

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 Physical Examination Form

Subject ID	Weight (kg)	BP (mmHg)	Pulse	Respiratory Rate	Temp (°C)	Fit for Dosing?
VOL-055	67	120/78	76	16	36.7	Yes

Annexure-2: Pre-Dose Examination Summary Log

Date	Subject ID	Examined By	Assessment	Remarks
16/04/2025	VOL-055	Dr. Sunita Reddy	Fit	Proceed to dosing

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial version	New study implementation	QA Head
17/04/2025	2.0	Updated with detailed assessment items	Regulatory audit feedback	QA Head