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SponsorInvestigator Responsibilities for IDEs IU Office of Research Administration (ORA) and Indiana Clinical and Translational Sciences Institute (CSI) Educational Session Summary Meeting Participants:Date:Regarding

How to fill out sponsor-investigator responsibilities for ides

How to fill out sponsor-investigator responsibilities for ides

1. Familiarize yourself with the responsibilities outlined in the IDes (Investigational Device Exemption) regulations.
2. Determine if you meet the qualifications to serve as a sponsor-investigator for IDEs. This typically requires having the necessary expertise, resources, and infrastructure.
3. Obtain any required approvals or certifications, such as an Investigational New Drug (IND) application or institutional review board (IRB) approval.
4. Develop a comprehensive plan for conducting the IDE study, including study design, participant recruitment, data collection and analysis, and safety reporting.
5. Ensure that all study participants are properly informed and provide informed consent.
6. Implement the study according to the approved plan, while adhering to good clinical practice (GCP) guidelines and applicable regulations.
7. Oversee the overall progress of the study, including monitoring participant safety, data quality, and timely reporting of adverse events or unanticipated problems.
8. Maintain complete and accurate documentation throughout the study, including study records, informed consent forms, and adverse event reports.
9. Keep track of investigational devices, including their storage, handling, and disposal.
10. Communicate regularly with the FDA and other relevant stakeholders regarding study progress, safety concerns, and any changes to the investigational devices or study protocols.
11. Complete all required reporting obligations, including annual reports, progress reports, and study completion reports.
12. Ensure that study results are appropriately disseminated, whether through publications, presentations, or other means.
13. Cooperate with FDA inspections and provide any requested information or documentation.
14. Continuously monitor and evaluate the study to identify and address any potential risks or compliance issues.

Who needs sponsor-investigator responsibilities for ides?

1. Investigators conducting clinical studies involving investigational devices under an IDE require sponsor-investigator responsibilities for IDEs.
2. Sponsors of IDE studies who are also acting as the primary investigator.

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What is sponsor-investigator responsibilities for IDEs?

Sponsor-investigator responsibilities for IDEs include ensuring the safety and well-being of study subjects, conducting the investigation in accordance with the approved protocol, and ensuring compliance with applicable regulations and guidelines.

Who is required to file sponsor-investigator responsibilities for IDEs?

The sponsor-investigator is required to file the sponsor-investigator responsibilities for IDEs.

How to fill out sponsor-investigator responsibilities for IDEs?

The sponsor-investigator responsibilities for IDEs can be filled out by providing all the necessary information regarding the study, including the protocol, study subjects, and compliance measures.

What is the purpose of sponsor-investigator responsibilities for IDEs?

The purpose of sponsor-investigator responsibilities for IDEs is to ensure the safety and integrity of the clinical investigation and to protect the rights and welfare of study subjects.

What information must be reported on sponsor-investigator responsibilities for IDEs?

The sponsor-investigator responsibilities for IDEs must include information about the study protocol, study subjects, adverse events, and any deviations from the approved protocol.