Research Compliance

• How are studies chosen for the Post Approval Monitoring Program?
• Who is notified that a protocol has been chosen?
• What will happen during the Post Monitoring Program visit?
• What materials will be reviewed?
• How long will the visit take?
• What happens after the monitoring visit?
• What types of actions could result from the review?
• What if I will be out of town or working on a grant within the few weeks after I receive a Post Monitoring Program notification?

 

How are studies chosen for Post Approval Monitoring Program?

Any study under the scope of the University of Texas at Dallas IRB is subject to review. Studies are chosen:

• At random or per other requests or indications
• Has an active approval status
• Has a full board or expedited review

Studies may be reviewed for:

• research where compliance concerns have been raised based upon information provided in continuing review reports, adverse events or other sources;
• research approval expires due to failure by the investigator to submit continuation status report and PI is requesting the study to be re-opened;
• research where paperwork submitted to the IRB was felt to be inadequate;
• protocols with junior investigators or inexperienced team members who may benefit from the post-approval monitoring program assessment
• for any change in PI after initial study approval and study remains open to enrollment

Who is notified that a protocol has been chosen?

A letter is sent via email to the principal investigator, and if applicable to:

• Study coordinator
• IRB coordinator
• Department contact

What will happen during the Post-Approval Monitoring Program visit?

The post approval monitor will meet briefly with the PI/study coordinator to become familiar with the study set-up and files. The post approval monitor will review all of the study materials and documentation. A final report of the findings will be written after the audit.

 

What materials will be reviewed?

The following documents are reviewed during the audit:

• Correspondence with the IRB
• Correspondence with any other institutional oversight committees (if applicable)
• Regulatory documents and correspondence with the Federal authorities and/or sponsor (if applicable)
• Original copies of the signed and dated consent forms for each subject or a sample of subjects
• Written documentation of the consent process for each subject
• Subject study records and any source documents
• Adherence to protocol
• Serious and/or Unexpected Adverse Event documentation and copies of required reports to the IRB, and to the federal authorities (if applicable)
• Research records (e.g., screening log, subject enrollment log, exclusion log and case report forms)
• Staff training or certification documentation (as applicable)
• Data entered for analysis (if applicable)

How long will the visit take?

The amount of time needed for a review varies greatly. Generally, the post approval monitor would like to meet with the PI for about 15-30 minutes either before, during or after the review of the study documents. The time needed to review the study documents depends on the amount of material and the number of subjects.

What happens after the monitoring visit?

When the audit is complete, the post approval monitor will:

• Meet with the PI/study coordinator if necessary, to discuss the findings
• Write a report of the findings
• Send a copy of the report to the PI, study coordinator, and the IRB.

What types of actions could result from the review?

There are several actions that could result from a review. They include:

• No follow up needed
• The Director of Research Compliance to follow-up with minor issues
• The IRB to follow up with major issues

What if I will be out of town or working on a grant within the few weeks after I receive notification?

That is fine. Please inform the post approval monitor of your situation and a date in the future can be arranged for the visit. For most of the monitoring visits, there is no specific deadline.