Fda Form 3674 - Top Of Page 1 - Uc Davis Health (Page 3 of 3) in pdf

Fda Form 3674 - Top Of Page 1 - Uc Davis Health Page 3

FDA form 3674 – more details

Which Trials Must be Registered?

The trials that must be registered are called “applicable clinical trials.” Under the statute, these trials generally

include:

Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase 1 investigations, of a

product subject to FDA regulation

Note: ICMJE requires registration of Phase I trials with efficacy endpoints. Therefore, the phase I

exemption probably does not apply to your trial.

Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric

postmarket surveillance.

When is the Deadline for Registration?

In order to publish in ICJME journals, you must register prior to enrollment of the first subject.

In order to comply with 42 USC § 282(j), you must register no later than 21 days after enrollment of the first

subject.

How do I Register my Study?

Duke Clinical Trials must be registered through the Office of Research Support (Wesley G. Byerly,

PharmD, Associate Dean).

Please contact them by sending an email to: rebeka.branagan@duke.edu. From there, you will get your

username and password.

DTMI Regulatory

Version 2

Fda Form 3674 - Top Of Page 1 - Uc Davis Health Page 3