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Monitoring Visit Checklist for Clinical Trial

Review protocol and consent forms

Verify all trial supplies are available

Review patient enrollment and withdrawal

Assess compliance with the study protocol

Approval: Protocol Compliance

Examine Case Report Forms (CRFs) for errors

Review Adverse Event and Serious Adverse Event reporting

Confirm data collected against source documents

Cross-check supporting documents and regulatory binder

Approval: Data Verification

Check all equipment is properly calibrated

Confirm all study team members are adequately trained

Ensure subject privacy is protected

Verify consent for new subjects

Evaluate trial management and procedures

Approval: Trial Procedures Compliance

Check for major protocol deviations or violations

Confirm that all unanticipated problems are duly reported

Review data management process to ensure accuracy and completeness

Approval: Final Monitoring Report

Verify all trial supplies are available

This task involves confirming the availability of all trial supplies required for the clinical trial. By verifying the availability of trial supplies, we ensure efficient and uninterrupted progress of the trial without any delays. It is essential to have all necessary supplies ready to maintain the study integrity and participant safety. The desired result is to have all trial supplies readily accessible for use when needed. Potential challenges can include delayed deliveries, incorrect quantities, or expired supplies. These challenges can be addressed by maintaining effective communication with the study sponsor, monitoring inventory levels, and establishing an efficient supply chain management. Resources required for this task include the trial supply list, storage area for supplies, and communication channels with suppliers and study personnel.

Are all trial supplies available and accessible?

Select the current status of trial supplies

1

All supplies available
2

Some supplies missing
3

Supplies expired
4

Supplies damaged

Which trial supplies need to be reordered or replaced?

1

Medications
2

Lab kits
3

Equipment
4

Patient diaries
5

Study pamphlets

Review patient enrollment and withdrawal

Assess compliance with the study protocol

Approval: Protocol Compliance

Review protocol and consent forms
Will be submitted

Examine Case Report Forms (CRFs) for errors

Review Adverse Event and Serious Adverse Event reporting

Confirm data collected against source documents

Cross-check supporting documents and regulatory binder

Approval: Data Verification

Examine Case Report Forms (CRFs) for errors
Will be submitted
Confirm data collected against source documents
Will be submitted
Cross-check supporting documents and regulatory binder
Will be submitted

Check all equipment is properly calibrated

Confirm all study team members are adequately trained

Ensure subject privacy is protected

Evaluate trial management and procedures

Approval: Trial Procedures Compliance

Check all equipment is properly calibrated
Will be submitted
Confirm all study team members are adequately trained
Will be submitted
Ensure subject privacy is protected
Will be submitted
Verify consent for new subjects
Will be submitted
Evaluate trial management and procedures
Will be submitted

Check for major protocol deviations or violations

Confirm that all unanticipated problems are duly reported

Review data management process to ensure accuracy and completeness

Approval: Final Monitoring Report

Check for major protocol deviations or violations
Will be submitted
Confirm that all unanticipated problems are duly reported
Will be submitted
Review data management process to ensure accuracy and completeness
Will be submitted