Standard Operating Procedure for Laboratory Safety Tests Prior to Dosing in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/057/2025
Supersedes	SOP/BA-BE/057/2022
Page No.	Page 1 of 11
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the procedure for performing and documenting laboratory safety tests on healthy volunteers before dosing in Bioavailability/Bioequivalence (BA/BE) studies, ensuring that only eligible and healthy participants proceed to drug administration.

2. Scope

This SOP applies to all clinical research staff and laboratory personnel involved in sample collection, analysis, result interpretation, and documentation of laboratory safety data before dosing in BA/BE clinical trials.

3. Responsibilities

• Clinical Laboratory Technician: Collects samples and performs tests as per protocol.
• Investigator/Sub-Investigator: Reviews lab reports and confirms subject eligibility based on findings.
• Clinical Research Coordinator: Coordinates sample logistics and maintains proper records.

4. Accountability

The Principal Investigator is accountable for ensuring that safety test results are reviewed, and subjects meet all protocol-defined safety parameters before dosing.

5. Procedure

5.1 Sample Collection

1. Collect blood and urine samples at least 48–72 hours prior to dosing or as defined in the protocol.
2. Label each sample with subject ID, date, time, and test panel using Annexure-1: Sample Collection Log.

5.2 Safety Test Panels

1. Perform the following baseline safety tests:
   • Hematology: CBC, Hemoglobin, WBC, Platelet count, ESR
   • Biochemistry: Liver Function Tests (ALT, AST, ALP, bilirubin), Renal Function Tests (urea, creatinine), glucose, electrolytes
   • Urinalysis: pH, protein, glucose, ketones, microscopic exam
   • Serology: HIV, HBsAg, HCV, VDRL
   • Pregnancy Test (for female subjects)
   • Drug abuse screening (if applicable)
2. Document results in Annexure-2: Laboratory Test Report Summary.

5.3 Result Review and Eligibility Confirmation

1. Sub-Investigator reviews all test reports for each subject.
2. Compare results against protocol-defined normal reference ranges.
3. Highlight any abnormal values and assess clinical relevance.
4. Confirm eligibility and document final decision in Annexure-3: Laboratory Review & Fitness Form.

5.4 Handling Abnormal Results

1. If any critical abnormality is observed:
   • Consult PI for medical opinion.
   • Repeat test if necessary.
   • Document findings and subject exclusion if applicable.

5.5 Recordkeeping

1. Attach signed and dated laboratory reports to the subject file.
2. Update subject eligibility status in the master screening log.
3. Ensure secure storage of original lab results and scanned copies in the eTMF system.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CBC: Complete Blood Count
• ALT/AST: Liver Enzymes
• PI: Principal Investigator
• eTMF: Electronic Trial Master File

7. Documents

1. Sample Collection Log – Annexure-1
2. Laboratory Test Report Summary – Annexure-2
3. Laboratory Review & Fitness Form – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• CDSCO Guidance on BA/BE Studies
• WHO GCP Manual

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Sample Collection Log

Subject ID	Date	Sample Type	Collected By	Remarks
VOL-057	15/04/2025	Blood	Rakesh Nair	Fasting sample

Annexure-2: Laboratory Test Report Summary

Test	Result	Unit	Reference Range	Status
Hemoglobin	13.9	g/dL	13.0–17.0	Normal
SGPT (ALT)	28	U/L	< 40	Normal

Annexure-3: Laboratory Review & Fitness Form

Subject ID	Reviewed By	Findings	Fit for Dosing?	Date
VOL-057	Dr. Sunita Reddy	All values within range	Yes	16/04/2025

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
14/01/2022	1.0	Initial version	GCP Compliance	QA Head
17/04/2025	2.0	Added structured annexures, clarified eligibility review	Protocol alignment	QA Head