Get Ide Decision Worksheet - Michigan Institute For Clinical & Health ... - Michr Umich

The Ide Decision Worksheet is a crucial tool for investigators at the University of Michigan to determine if an Investigational Device Exemption (IDE) is needed for FDA and IRB approvals before commencing a medical device clinical study. This guide provides step-by-step instructions to assist users in accurately completing this worksheet online.

Follow the steps to complete the Ide Decision Worksheet efficiently.

1. Click the ‘Get Form’ button to access the Ide Decision Worksheet and open it in your document editor.
2. Fill in your information in the 'Investigator Name' field. Ensure your name is clearly written, as this identifies you as the primary investigator.
3. Provide the 'Investigational Device Name & Manufacturer' in the appropriate field. Enter the specific name of the investigational device along with the manufacturer's name.
4. Enter the 'Protocol/Study Title' in the designated area. This should reflect the overall title of your clinical study.
5. Proceed to the IDE Requirements Decision Criteria section. Answer each question carefully to determine whether your study involves a medical device and if it meets the necessary criteria in accordance with FDA regulations.
6. For each criterion numbered 1 to 6, select 'Yes' or 'No' as applicable to your study. Ensure that you provide any necessary details or explanations as required, particularly for questions related to significant risks.
7. If required, document your assessment of whether the devices involved are classified as Significant Risk or Non-Significant Risk according to the criteria specified. Provide detailed responses for the sub-questions (3.a-e) and (4.a-d) to justify your evaluations.
8. Finalize your responses and make sure all fields are completed accurately. This includes ensuring that your answers align with the study's protocol and the device's classifications.
9. Once you have reviewed the entire document for accuracy, save your changes, download the completed form, or print it as necessary. You may also share the form as required for further approvals.

Complete the Ide Decision Worksheet online today to facilitate your clinical study process.