You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
During a routine monitoring visit of a physician-sponsored IDE study, it was noted that the site was receiving “waivers” from the Sponsor to enroll subjects who did not meet one of the anatomical exclusion criteria. A
From the FDA’s perspective, did the Sponsor do enough?
Topics: Protocol Deviations, FDA, Sponsor, Physician-Sponsored IDE Study, Clinical Monitoring
When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Sponsored 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.
Topics: Whitepaper, IMARC Research, FDA, Physician-Sponsored IDE Study
Please take time to review IMARC Research’s new whitepaper entitled “Conducting a Physician-Sponsored Investigational Device Exemption - Laying the Regulatory Groundwork for Success.” When a Sponsor-Investigator conducts a device study, it may be referred to as a Physician-Sponsored IDE (PS-IDE).
Topics: IMARC Research Whitepaper, Regulatory, Physician-Sponsored IDE Study, PS-IDE