What is an Investigator Initiated Trial?
In an Investigator Initiated Trial, a clearly defined third-party (e.g. a clinician, a hospital, a research facility, etc.) initiates the study supported by a research grant received by Atos Medical provided study-related financial and/or product support. Investigator Initiated Trials provide an opportunity for clinicians and researchers to advance their scientific acumen with study-related financial and/or product support.
In Investigator Initiated Trials, an Investigator takes on the role as both Investigator and Sponsor. The Investigator/Sponsor may be an individual, company, institution, or organization that takes responsibility for planning, initiation, management, and regulatory compliance for the conduct of a clinical study. There can only be one Sponsor per study.
In an Investigator Initiated Trial, an Investigator may wish to perform a clinical study with a company product. Atos Medical may be willing to support these studies without taking the role of Sponsor. In this situation, the Sponsor would be the Investigator who proposed the investigation and who enters into an agreement with Atos Medical and who will be taking both the responsibility of initiating and conducting the clinical study.
What are the responsibilities of the Investigator?
The Investigator will bear all obligations related to responsibility for study conception, design, operational execution, data handling, data analysis/interpretation, subsequent reporting/publication, and ensuring compliance with all local laws and regulations. The list of responsibilities is non-exhaustive and could cover the following tasks:
- Protocol development
- Submit application and required documents to ethical committees/ authorities and ensures that required approvals are obtained prior to study initiation
- Register the trial on Clinicaltrials.gov (or any other publicly available database)
- Ensure that all patient-related information has been provided to the patient and provide study supplies to patient
- Ensure that all patient-related information has been provided to the patient and provide study supplies to patient
- Ensure Institutional Review Board/Ethics Committee approval prior to initiating the investigation
- Develop Case Report Forms and data collection tools
- Monitor and ensure study conduct according to protocol and regulation
- Report all serious adverse events to authorities according to guidelines and serious adverse device-related events to Atos Medical
- Perform data analysis and report findings
- Indemnification of the investigator or insurance of the patient
- Deliver according to agreed timelines and provide study updates to Atos Medical
What are the responsibilities of Atos Medical?
Atos Medical commits to review the Investigator Initiated Trial proposal and provide its initial feedback and potential requests for further information within 5 days.
If the eventual study is accepted and funding is approved, an Investigator Initiated Trial Agreement defining roles and obligations will be entered into between the Investigator and Atos Medical.
It is Atos Medicals’ responsibility to supply the support agreed between Atos Medical and the Investigator according to the Investigator Initiated Study Agreement.
Click here to apply for support for your clinical study.
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