{
“@context”: “https://schema.org”,
“@type”: “Article”,
“mainEntityOfPage”: {
“@type”: “WebPage”,
“@id”: “https://www.Clinicalstudies.in/SOP-for-Screening-Pre-Screening-Logs-and-Procedures”
},
“headline”: “SOP for Screening and Pre-Screening Logs and Procedures in Clinical Trials”,
“description”: “This SOP outlines the standardized process for conducting screening and pre-screening of participants in clinical trials, including log maintenance, eligibility assessment, documentation, and compliance with GCP, FDA, EMA, CDSCO, and WHO guidelines.”,
“author”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”
},
“publisher”: {
“@type”: “Organization”,
“name”: “ClinicalStudies.in”,
“logo”: {
“@type”: “ImageObject”,
“url”: “https://www.clinicalstudies.in/logo.png”
}
},
“datePublished”: “2025-08-26”,
“dateModified”: “2025-08-26”
}

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

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

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

References

• ICH E6(R2) – Good Clinical Practice
• US FDA – Clinical Trial Oversight
• EMA Clinical Trial Regulation
• CDSCO Clinical Trial Rules, 2019
• WHO – Ethical Guidelines for Clinical Research

Version: 1.0

Approval Section

Annexures

Annexure-1: Pre-Screening Log

Annexure-2: Screening Log

Annexure-3: Screening Failure Log

Revision History

For more SOPs visit: Pharma SOP