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Nxa6KNfUmUYf5uT9Drtn39mupjfMT2Ra2PM22nDv9z6NjTtM2LCn4yY3XoIKFU2yzMCaMsWhLjbde9kxEBbuFzQLUtHRmiU8

VCU Clinical Research Quality Assurance Assessment

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If you have been monitored by a CRO, Massey Cancer Center, VCU Johnson Center, or other interal / external groups, please have the last monitoring report available prior to completing this form.

If your study team is completing the monitoring, please complete your Quality Control and finish the VCU Clinical Research Quality Assurance ASsessment Worksheet before you complete this survey. Have your signed worksheet available to upload.

If you have questions about the Quality Control (QC) process or about completion of this form please contact me at elizabeth.ripley@vcuhealth.org.

Thank you,

Betsy Ripley, MD, MS, RAC

VCU Clinical Research Compliance Officer

IRB Protocol Number

* must provide value

PI Last Name

* must provide value

PI First Name

Name (First, Last) of Person this Form

* must provide value

Email of Person Completing this Form

* must provide value

Phone Number for Person Completing this Form

* must provide value

In the last year, has your study been monitored by a CRO, Massey Cancer Center, VCU Johnson Center, or other Internal/External Monitoring Group?

* must provide value

Yes

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What Group has Monitored your Study?

* must provide value

When was your Last Monitoring Visit?

* must provide value

M-D-Y

Is this Monitoring Report in OnCore?

* must provide value

Yes

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Upload the Monitoring Report here.

Upload file

Have you monitored your study and completed the VCU Clinical Research Quality Assurance Assessment Worksheet?

* must provide value

Yes

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Please complete the following Quality Assurance Assessment for your study. The goal is to assure that your study is being conducted according to Federal Regulations, Policies, Guidance, VCU policies, and conditions of IRB approval.

Once the form is filled out and self monitoring is complete, please return and finish this survey.

Attachment:VCU Clinical Research QA Assessment v2.pdf

Please Upload the completed VCU Clinical Research Quality Assurance Assessment Worksheet

* must provide value

Upload file

Has study monitoring identified any amendment that needs to be submitted or was submitted to the IRB?

* must provide value

Yes

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Has the amendment been submitted?

Yes

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Has monitoring identified any issues that need to be reported to the IRB?

* must provide value

Yes

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Has the identified issue(s) been reported?

* must provide value

Yes

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During the review have you identified any problems or concerns that you are addressing which did not need to be reported or submitted as an amendment?

* must provide value

Yes

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Please provide any other comments or feedback.

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How helpful was your monitoring to assure the quality of your research?

Change the slider above to set a response

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You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.