CRA Monitoring Checklist

Clinical research associates (CRAs) play a crucial role in the conduct of clinical trials, ensuring that studies are carried out in compliance with regulatory requirements, sponsor protocols, and ethical standards. One of the key responsibilities of a CRA is to conduct monitoring visits to trial sites. These visits are essential for verifying the accuracy of data, ensuring patient safety, and maintaining the integrity of the trial. A comprehensive checklist is an invaluable tool for CRAs to systematically review all aspects of the trial during these visits. This blog outlines a detailed CRA monitoring visit checklist to guide CRAs in their critical role.

Checklist Category	Tasks	Notes
Pre-Visit Preparation	Review protocol and relevant documents	Study protocol, CRFs, amendments, etc.
	Confirm visit date and staff availability	Communication with site staff
	Review previous monitoring reports and follow-up actions	Identify unresolved issues
Arrival at the Site	Check-in and meet with the PI and site staff	Confirm agenda
	Secure a dedicated workspace with necessary resources	Internet, power outlets
Informed Consent Verification	Verify properly filled, signed, and dated informed consent forms	Ensure compliance with protocol versions
	Confirm version control for each consent form	Check for protocol amendments
	Document consent process in participants’ medical records
Regulatory Documentation	Verify essential documents are complete and current	Investigator’s Brochure, approvals, delegation logs
	Review Investigator Site File (ISF)	Completeness and organization
	Check training records of site staff	Protocol training, amendments
Source Data Verification (SDV)	Cross-check CRF data with source documents	Medical records, lab reports
	Ensure data accuracy, completeness, and timeliness	Address discrepancies immediately
	Resolve queries with site staff
Drug Accountability	Verify proper storage conditions for investigational product (IP)	As per protocol
	Check drug accountability logs	Receipt, dispensing, and return
	Ensure no expired IP is stored or used
Adverse Event (AE) Reporting	Review AE documentation	Logs, regulatory compliance
	Verify timely reporting of Serious Adverse Events (SAEs)	To sponsor and ethics committee
Protocol Compliance	Confirm participants meet eligibility criteria	Inclusion/exclusion criteria
	Verify adherence to visit schedule	As per protocol
	Document and address protocol deviations	Discuss corrective actions
Site Staff Interaction	Discuss trial progress and issues with the PI	Resolution of findings
	Identify and address site staff training needs	Provide or arrange training
	Provide constructive feedback to site staff
Documentation and Reporting	Prepare a detailed monitoring report	Findings, identified issues, actions taken
	List action items for site staff	Follow-up required
	Communicate findings to sponsor	Significant issues
Follow-Up Activities	Ensure resolution of issues identified during the visit	Monitor site updates
	Verify necessary document updates	Based on findings
	Plan next monitoring visit	Focus on unresolved or critical issues

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