What are the IRB Submission Requirements for Compassionate Use Investigational Devices?
For Quorum, a proposed compassionate use of an Investigational Device should be submitted as a single site study. We will need the following documents:
- Single Site Study Questionnaire (SSSQ) Form,
- Site Information Questionnaire (SIQ) Form,
- the study protocol,
- the device manual,
- device form,
- any participant materials that the participant may fill out (i.e. questionnaires or diaries), and
- a consent form.
The protocol should include the information that was previously included in the Investigational Device Exemption (IDE) supplement, specifically:
- A description of the patient’s condition and the circumstances necessitating treatment;
- A discussion of why alternatives therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition;
- An identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient; and
- The patient protection measures listed above that will be followed.
- A monitoring schedule, which should include the investigational nature of the device and the specific needs of the patient. The patient should be monitored to detect any possible problems arising from the device.
For Quorum’s purposes, the submitted consent form may be based off of the consent form for the approved clinical trial.
Please contact our Initial Study Support department for more information on submission requirements or access to our Regulatory Attorney Team. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.