Investigator Initiated Trials – IIT

Conduction of industry-independent clinical studies

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IIT – Investigator Initiated Trials
Self-assessment (sponsor’s responsibilities)
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Self-assessment questionnaire (sponsor’s responsibilities)

Do you have experience with the conduct of clinical studies?

Yes

Do you have a quality management system, which describes your standard processes to which you as sponsor are reponsible for?

Yes

Do you have adequatly qualified personnel to plan, design, start, oversee, perform quality control and analysis, and do you have validated systems/software to send safety reports to authorities?

Yes

Do you like to deal with regulatory issues?

Yes

Do you prefer bureaucratic regulations over medical activities?

Yes

Congratulations! You seem to fulfill all requirements to take over Sponsor's responsibilities in an Investigator Initiated Trial (IIT). We wish you all the best for your successful study conduct.

As you answered one of the questions above with no, you should seek for support for your study preparation.

We help you like many other enthusiastic physicians with the realization of great ideas.