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Which of the following is a report that sponsors must submit to regulatory authorities during the conduct of a clinical investigation?

a) Investigator's Brochure (IB)
b) Case Report Form (CRF)
c) Investigational New Drug (IND) application
d) Annual Progress Report

1 Answer

1 vote

Final answer:

The report that sponsors must submit to regulatory authorities during a clinical investigation is the Annual Progress Report.

Step-by-step explanation:

The report that sponsors must submit to regulatory authorities during the conduct of a clinical investigation is the Annual Progress Report. This report provides an update on the progress of the clinical investigation, including information on the number of participants enrolled, any adverse events observed, and the overall safety and effectiveness of the therapy being investigated.

answered
User Uriel Bertoche
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