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Compliance In Focus
Posted by John Lehmann on Mon, Dec 30, 2013

Laying the Regulatory Groundwork for a Successful Physician-Sponsored IDE Study

When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Laying the Regulatory Groundwork for a Successful Physician Sponsored IDE StudySponsored IDE (PS-IDE). Chaos can sometimes ensue when one begins down the path of a PS-IDE. This whitepaper will attempt to make sense of that chaos by providing a brief overview of initiating a PS-IDE, the responsibilities of the investigator, the additional sponsor responsibilities assumed by the Sponsor-Investigator, and a thoughtful discussion on the records and reports of the Sponsor-Investigator.  Relevant FDA warning letter findings issued to Sponsor-Investigators and some suggestions to ensure a well-controlled clinical study are reviewed.

The importance of setting the study up for success from its onset cannot be emphasized enough.  Implementing the Franklin Covey philosophy to “begin with the end in mind” will help ensure a well-controlled study in which patients are protected and data has integrity.

Some recommendations for a successful start include:

  • Hire a monitor who is not only qualified by training and experience to monitor a PS-IDE but who is in no other way affiliated with the study (i.e., don’t have the study coordinator also be the monitor)
  • Develop standard procedures specific to the site and specific to the sponsor
  • Construct a communication plan, including the intended plan for documenting the communication.  Commit to documenting what you already know (i.e., if you as the investigator created the amendment to the protocol along with your co-investigators, still document that training occurred as it becomes easy to take things for granted when you’re wearing two hats).  Include yourself as a recipient on correspondence, such as electronic mail for communication such as the annual progress report
  • List all the possible documents and where they will be kept
  • Consider hiring an outside auditor to inspect the study documents and processes
  • Conduct warning letter reviews yourself at monthly study team meetings to assess how you stack up

In closing, conducting a PS-IDE can be a challenging task which requires a Sponsor-Investigator to wear two hats.  Having monitored PS-IDE studies, we have witnessed firsthand not only innovative but successful ways these dedicated physicians accomplish this feat.

Please take time to review IMARC Research’s whitepaper titled “Conducting a Physician-Sponsored Investigational Device Exemption - Laying the Regulatory Groundwork for Success.” It is our sincere hope that this whitepaper can serve as a resource for those wishing to conduct a PS-IDE study.

Photo Credit: marc falardeau

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Topics: Whitepaper, IMARC Research, FDA, Physician-Sponsored IDE Study


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