27 January, 2026
Author : Dr Vijaykumar Gawali

Topic : MONITORING VISITS – SITE PREPARATION & ACTIVITIES

1 Definition

A Monitoring Visit is conducted by the Clinical Research Associate (CRA) on behalf of the sponsor to verify that:

• participant safety is protected
• trial data is accurate and verifiable
• the site is following the approved protocol and ICH-GCP
• the Investigator Site File (ISF) is complete and up-to-date
• the Investigational Product (IP) is managed correctly

Monitoring visits may be:

• Site Qualification Visit (SQV)
• Site Initiation Visit (SIV)
• Routine Monitoring Visit (RMV)
• Close-Out Visit (COV)

2 Purpose of a Routine Monitoring Visit (RMV)

• Source Data Verification (SDV)
• Source Data Review (SDR)
• Review of IP accountability
• AE/SAE review and compliance with reporting timelines
• Review of deviations, missing data, and protocol compliance
• Ensure ISF completeness
• Evaluate PI oversight
• Ensure documentation readiness for audits

3 CRC Responsibilities for Monitoring Visit Preparation

3.1 Source Document Preparation

CRC ensures:

• Source notes for every visit are complete, signed, and contemporaneous
• Lab reports, ECGs, imaging reports are filed chronologically
• Visit worksheets completed
• Eligibility documents available
• Visit windows documented

3.2 eCRF Completion

Before CRA arrives:

• All forms must be updated
• Queries should be resolved or flagged
• Missing data documented with reasons
• End-of-visit assessments verified with source

CRC should generate an internal “data completeness check” before the visit.

3.3 IP Accountability Preparation

CRC ensures:

• IP dispensing, return, and reconciliation logs are updated
• Temperature logs complete with no missing entries
• IP segregated (used, unused, quarantined)
• IWRS entries match physical stock

3.4 AE/SAE Documentation

CRC prepares:

• AE logs
• SAE Table-5 forms
• medical records (discharge summary, lab reports)
• PI causality assessments
• EC and sponsor SAE acknowledgements

The CRA will cross-check each AE/SAE with source notes, CRFs, and ISF records.

3.5 ISF Review

CRC verifies:

• Latest approvals filed
• Updated CVs, GCP certificates
• Training logs
• Protocol/SOP updates
• EC acknowledgements
• Screening/enrollment logs

3.6 PI Availability

The PI must meet the CRA during each visit to ensure oversight.

CRC should plan:

• PI availability for 10–30 minutes
• Time to discuss SAE decisions, protocol deviations, and site issues

4 Step-by-Step Workflow on Monitoring Day

• CRA arrival → site tour (optional)
• Review of ISF
• SDV – line-by-line checking of source vs. CRF
• SDR – review of quality of documentation
• Review of AE/SAE reporting
• Review of IP storage, logs, and inventory
• Review of deviations & CAPA
• Review of pending queries
• PI discussion
• CRA writes report; CRC reviews next steps