Standard Operating Procedure for Volunteer Screening and Selection Criteria in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/051/2025
Supersedes	SOP/BA-BE/051/2022
Page No.	Page 1 of 12
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the procedure for screening and selecting healthy volunteers for participation in Bioavailability/Bioequivalence (BA/BE) studies, ensuring subject safety and compliance with ethical and regulatory requirements.

2. Scope

This SOP applies to all volunteer screening activities conducted prior to enrollment in BA/BE studies within the clinical facility, including initial registration, medical assessment, laboratory testing, and eligibility confirmation.

3. Responsibilities

• Screening Physician: Conducts physical examination, reviews medical history, and assesses clinical test results.
• Clinical Research Coordinator: Manages volunteer registration, obtains consent, and ensures protocol-specific criteria are followed.
• Lab Technician: Collects and processes blood/urine samples for screening assessments.
• Volunteer Recruitment Staff: Informs prospective volunteers about the study and facilitates scheduling of screening visits.

4. Accountability

The Principal Investigator is accountable for ensuring that all volunteers meet the protocol-defined eligibility criteria before inclusion in the study.

5. Procedure

5.1 Volunteer Registration and Identity Verification

1. Register volunteers in the screening database using a unique ID number.
2. Verify identity using government-issued photo ID (e.g., Aadhar card, PAN card, driving license).
3. Document demographic details in Annexure-1: Volunteer Registration Form.

5.2 Informed Consent

1. Provide the screening informed consent form (ICF) in the local language.
2. Explain study purpose, procedures, risks, and rights.
3. Obtain signature/thumb impression on ICF before any screening activity.

5.3 Medical History and Lifestyle Assessment

1. Record history of past or present illness, allergies, surgeries, medication use, and substance abuse.
2. Evaluate lifestyle factors such as tobacco, alcohol, or caffeine intake using Annexure-2: Medical History Questionnaire.

5.4 Physical Examination

1. Conduct physical examination including height, weight, BMI, temperature, pulse, BP, and systemic evaluation.
2. Document findings in Annexure-3: Physical Examination Record.

5.5 Laboratory and Diagnostic Testing

1. Perform following tests:
   • Hematology: CBC, ESR
   • Biochemistry: LFT, RFT, glucose, electrolytes
   • Serology: HIV, HBsAg, HCV, VDRL
   • Urinalysis: Routine and drug screening
   • ECG (as per protocol)
2. Record results in Annexure-4: Laboratory Screening Report.

5.6 Eligibility Evaluation

1. Compare screening data against protocol inclusion and exclusion criteria.
2. Document the eligibility decision in Annexure-5: Eligibility Assessment Form.
3. Only eligible volunteers are scheduled for dosing; ineligible subjects are notified and excluded.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• ICF: Informed Consent Form
• BMI: Body Mass Index
• PI: Principal Investigator
• ECG: Electrocardiogram

7. Documents

1. Volunteer Registration Form – Annexure-1
2. Medical History Questionnaire – Annexure-2
3. Physical Examination Record – Annexure-3
4. Laboratory Screening Report – Annexure-4
5. Eligibility Assessment Form – Annexure-5

8. References

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

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 Registration Form

Volunteer ID	Name	Gender	Age	ID Proof Type	ID No.	Contact
VOL-051	Rakesh Yadav	Male	28	Aadhar	XXXX-XXXX-1234	9876543210

Annexure-2: Medical History Questionnaire

Condition	Yes/No	Details (if yes)
Diabetes	No	–
Allergies	Yes	Penicillin

Annexure-3: Physical Examination Record

Height (cm)	Weight (kg)	BMI	BP (mmHg)	Pulse (bpm)
172	68	23.0	118/76	74

Annexure-4: Laboratory Screening Report

Test	Result	Unit	Reference Range	Status
Hb	14.2	g/dL	13.0–17.0	Normal

Annexure-5: Eligibility Assessment Form

Volunteer ID	Screened By	Eligible (Y/N)	Remarks
VOL-051	Dr. Sunita Reddy	Yes	Meets all criteria

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial version	First implementation	QA Head
17/04/2025	2.0	Updated to include ICF and annexures	Compliance with CDSCO and WHO GCP	QA Head