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Research Compliance


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  • Kathryn, We have a process in place for situations like this. Mostly based upon the "merit" of the particular study. If the study has the potential to provide useful medical information, information that may eventually lead to a better treatment...

  • Before we allow any study to begin enrollment, we require that PIs identify a funding source (usually departmental funds) that will cover overages such as what you describe. We charge the study account and the invoice goes to the coordinator whether...

  • To qualify for the study, a specific genetic testing needs to be done, which can be expensive. A potential participant already had the genetic testing done a year ago, but to participate in the study the testing needs to be performed within 3 months...

  • In the medical record. Always. ---Sent from my iPhone via dictation to Siri so please excuse typos and brevity. _________________________________________ David Vulcano, LCSW, MBA, CIP, RAC | AVP & Responsible Executive, Clinical...

  • David,Thanks for responding. So to clarify your comment, are you suggesting that the ICF and HIPAA Authorization should NOT be placed on the electronic medical record if the patient is under a CoC? Or should the ICF, HIPAA and a copy of the CoC be...

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