(CRC): Assigns volunteer IDs and ensures screening logs are accurately maintained.

PI/Sub-Investigator: Reviews screening outcomes and confirms volunteer eligibility.

Data Entry Operator: Ensures electronic logs match physical documentation.

QA Officer: Verifies completeness and traceability during audits and inspections.

4. Accountability

The Principal Investigator is accountable for ensuring that volunteer identification and screening records are maintained accurately and securely, and that only eligible volunteers are enrolled based on validated documentation.

5. Procedure

5.1 Volunteer Identification and ID Assignment

1. Upon first contact, assign a temporary screening number (e.g., SCR-105-001).
2. If eligible post-screening, assign a permanent Volunteer ID (e.g., VOL-105-001) for use in CRFs, sample labels, etc.
3. Enter details into Annexure-1: Volunteer Screening and ID Log.

5.2 Screening Process Documentation

1. Record each volunteer’s:
   • Name
   • Contact details
   • Date of screening
   • Screening status (Pass/Fail)
2. Capture reasons for screening failure, if any (e.g., out-of-range vitals, lab abnormality).
3. Use Annexure-2: Volunteer Screening Outcome Form for each individual.

5.3 Updating Logs and Traceability

1. Ensure logs are updated on the same day of the screening.
2. All records must be signed and dated by the CRC or PI.
3. Cross-verify paper records with digital logs weekly (Annexure-3: Log Verification Checklist).

5.4 Record Confidentiality

1. Store screening logs with personal identifiers in a locked file room with restricted access.
2. Volunteer IDs used in study records must not reveal names or contact information.

5.5 Archival

1. At the end of study, archive all screening logs with study documentation.
2. Maintain logs for the period defined by the sponsor/regulatory agency (typically 5 years).

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• ID: Identification

7. Documents

1. Volunteer Screening and ID Log – Annexure-1
2. Volunteer Screening Outcome Form – Annexure-2
3. Log Verification Checklist – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Indian GCP Guidelines
• Schedule Y – Drugs and Cosmetics Rules

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 Screening and ID Log

SCR No.	VOL ID	Full Name	Screening Date	Status	Remarks
SCR-105-001	VOL-105-001	Rajesh Kumar	12/04/2025	Passed	Eligible

Annexure-2: Volunteer Screening Outcome Form

Volunteer Name	Date of Screening	Tests Performed	Result	Screening Status	Comments
Sunita Reddy	14/04/2025	Vitals, Labs	Normal	Passed	Ready for dosing

Annexure-3: Log Verification Checklist

Date	Verified By	Discrepancies Found	Corrective Action
15/04/2025	QA Officer	None	NA

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial Release	GCP Requirement	QA Head
17/04/2025	2.0	Annexures added; electronic verification added	Process Improvement	QA Head