AI Checklist Generator

Email address

Home > CRA checklist for SDV

CRA checklist for SDV

Review the study protocol and monitoring plan

Verify the site selection and feasibility assessment

Confirm the availability of source documents

Ensure that all study documents are up to date and accessible

Prepare a list of key contacts for the study site

Confirm the initiation visit schedule with the site

Review the informed consent process with the site staff

Ensure the site has all necessary study supplies and equipment

Discuss the roles and responsibilities of site staff

Verify the site’s understanding of the study protocol

Identify source documents required for verification

Cross-check case report forms (CRFs) against source documents

Ensure accuracy of data entered in CRFs

Document any discrepancies found during verification

Confirm the resolution of discrepancies with site staff

Evaluate the completeness and consistency of data

Review data entry processes and timelines

Assess the adherence to Good Clinical Practice (GCP) guidelines

Conduct periodic audits of data quality

Provide feedback to site staff on data management practices

Schedule regular monitoring visits based on the monitoring plan

Maintain communication with the study site throughout the study

Monitor for protocol deviations and adverse events

Review and document site performance metrics

Ensure timely submission of monitoring reports

Conduct a final review of all data and documents

Confirm resolution of outstanding issues or queries

Prepare for the closeout visit with the site

Ensure all necessary documentation is collected and archived

Provide a final report to the sponsor and stakeholders

Hey there! Here's a little about us or visit our recurring workflow SaaS: Manifestly Checklists

Light Dark