In Investigator Initiated Studies 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 Study, an Investigator may wish to perform a clinical study with a company product. Coloplast 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 the agreement with Coloplast and who will be taking both the responsibility of initiating and conducting the clinical study.

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 authorities 
• Register the trial on Clinicaltrials.gov 
• Select qualified sub-investigators, sites and monitors, if relevant
• Ensure that all patient-related information has been provided to the 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
• Provide study supplies and/or investigational product
• Report all serious adverse events to authorities according to guidelines
• Report serious adverse device-related events to Coloplast 
• Perform data analysis and report findings
• Final study reports Indemnification of the investigator or insurance of the patient
• Deliver according to agreed timelines and provide study updates to Coloplast

Coloplast commits to review the Investigator Initiated Study proposal and provide its feedback and potential requests for further information within 1 month.

If the eventual study is accepted and funding is approved an Investigator Initiated Study Agreement defining roles and obligations will be entered into between the Investigator and Coloplast.

It is Coloplast’s responsibility to supply the support agreed between Coloplast and the Investigator according to the Investigator Initiated Study Agreement.