POST APPROVAL MONITORING F.A.Q.'s
(1) What is Post Approval Monitoring?
(2) What are Some of the Benefits that an Investigator may Gain?
(3) How are Research Projects Selected?
(4) How Long Will the Assessment Take?
(5) What Should I Expect?
(6) What are the Possible Outcomes?
(7) When will I Know of the Outcome?
(8) What if the Primary Investigator is Unable to Attend the Meeting?
(1) What is Post Approval Monitoring?
Post Approval Monitoring is an examination of the research facility and study documents to assure that human subjects are protected, and the investigator is in compliance with applicable University and Federal regulations. Conducting post approval monitoring will help to ensure that appropriate applications and supporting documents are executed as approved, any changes or adverse events are reported, and the consent forms are approved.
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(2) What are Some of the Benefits that an Investigator May Gain?
Some possible benefits that may be gained from a review include but are not limited to:
* increased understanding of the regulations that guide all our research projects
* increased communication concerning updates to federal and university regulations
* access to resources and individuals to clarify the federal and university regulations
(3) How are Research Projects Selected?
The majority of protocols are selected randomly. Projects whose subjects are at a greater risk have a higher chance of being selected. If a protocol has been selected, it does not necessarily mean the investigator is doing something wrong.
Protocols can be selected “for-cause” from a complainant (study subject, study personnel, anonymous, etc.).
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(4) How Long Will the Assessment Take?
If your documents are complete and organized, the review will take about one hour. If an investigator is not prepared, the review may take several hours.
(5) What Should I Expect?
The following assessment tool will be used: IRB
You will be asked to pull records / files and present the storage location and security methods to the PAM officer. You will be asked questions about how the research project is going in relation to problems, complaints from study participants, adverse events, etc.. The PAM officer may request to view the consenting process or study procedures, as appropriate and with the approval of study participants. The scope of review varies greatly depending on the research, but may include:
* Record retention and security of consent documents and data collection instruments (e.g., survey’s, and videotapes)
* Appropriate use of approved supporting documents
* Risk assessment
* Study procedures consistent with application
* Consent process
(6) What are the Possible Outcomes?
There are several actions that could result from a PAM review. They include:
* Compliant, no follow up needed.
* Minor deficiencies, the investigator completes the assessment's resolution comment column with their plans to address the issues within one month and emails the document back to the PAM officer.
* Significant deficiencies, the investigator completes the assessment's resolution comment column with their plans to address the issues within the specified time and emails the document back to the PAM officer. Furthermore, the investigator will be reviewed again within six months to assure compliance. The IRB will be notified of significant violations.
(7) When will I Know of the Outcome?
About a week from the review date.
(8) What if the Primary Investigator is Unable to Attend the Meeting?
It is preferred; however, you may designate a representative if you cannot attend.