SOP for Screening/Pre-Screening Logs and Procedures

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Published on 21/12/2025

Standard Operating Procedure for Screening/Pre-Screening Logs and Procedures

Department	Clinical Research
SOP No.	CR/SCR/025/2025
Supersedes	NA
Page No.	1 of 22
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

Purpose

The purpose of this SOP is to define the procedures for conducting screening and pre-screening of participants in clinical trials. It establishes standardized practices for

maintaining screening logs, assessing eligibility, documenting outcomes, and ensuring compliance with regulatory guidelines.

Scope

This SOP applies to investigators, sub-investigators, study coordinators, and site staff involved in participant screening and pre-screening activities for clinical trials. It includes screening failures, pre-screening contacts, and full eligibility assessments prior to enrollment.

Responsibilities

Principal Investigator (PI): Oversees screening activities and ensures eligibility criteria are applied correctly.
Study Coordinator: Maintains screening and pre-screening logs and ensures accurate documentation.
Investigators/Sub-Investigators: Perform medical evaluations to confirm eligibility.
Sponsor/CRO: Monitors screening procedures for compliance during site visits.
Quality Assurance Officer: Reviews logs during audits and inspections.

Accountability

The PI is accountable for ensuring that all participants are screened ethically, with confidentiality maintained, and only eligible participants are enrolled into the trial. All screening activities must be documented in compliance with ICH GCP and applicable regulations.

Procedure

1. Pre-Screening Activities
Conduct initial contact via phone, email, or outreach to assess interest.
Collect non-identifiable information to assess preliminary eligibility.
Document outcomes in the Pre-Screening Log (Annexure-1).

2. Screening Activities
Obtain written informed consent prior to screening procedures.
Record demographic details, medical history, and relevant assessments.
Apply inclusion and exclusion criteria as per approved protocol.
Document outcomes in the Screening Log (Annexure-2).

3. Documentation
Maintain separate logs for pre-screening and screening.
Ensure all logs are signed and dated by responsible staff.
File logs in Investigator Site File (ISF) and Trial Master File (TMF).

4. Screening Failures
Record all participants who fail screening with reasons documented.
Ensure confidentiality of participant information is protected.

5. Monitoring and Oversight
Sponsors and monitors must review logs during monitoring visits.
Correct discrepancies and document CAPA as needed.

6. Archiving
Archive logs for at least 5 years post-trial or as per local regulations.

Abbreviations

SOP: Standard Operating Procedure
PI: Principal Investigator
CRO: Clinical Research Organization
ISF: Investigator Site File
TMF: Trial Master File
CAPA: Corrective and Preventive Actions
QA: Quality Assurance

Documents

Pre-Screening Log (Annexure-1)
Screening Log (Annexure-2)
Screening Failure Log (Annexure-3)

References

Version: 1.0

Approval Section

Prepared By	Rajesh Kumar, Clinical Research Coordinator
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Principal Investigator

Annexures

Annexure-1: Pre-Screening Log

Date	Initials	Contact Method	Preliminary Eligibility	Staff
10/09/2025	RK	Phone	Eligible	Ravi Kumar

Annexure-2: Screening Log

Date	Participant ID	Consent Obtained	Eligibility Outcome	Investigator
12/09/2025	PAT-021	Yes	Eligible	Dr. Meera Joshi

Annexure-3: Screening Failure Log

Date	Participant ID	Reason for Failure	Recorded By
14/09/2025	PAT-024	Exclusion: Abnormal liver function	Sunita Sharma

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head, Clinical Research

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