This is your one stop shop for updates on CTTI projects, developments in the clinical trials enterprise and other relevant news. To read the full-length entry, or to share a specific blog post, click on the title of the article of interest.
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The NIH has selected CTTI to support a workgroup that will develop a comprehensive plan for assessing the NIH’s new single institutional review board (sIRB) policy. The policy, which became effective in January, requires U.S. sites participating in nonexempt multicenter human subjects research funded by the NIH to use a sIRB for ethical review, with the goal of improving the quality and efficiency of clinical research.
“For nearly a decade...
The Reagan-Udall Foundation for the FDA presented CTTI with the Innovations in Regulatory Science Award on Tues., Dec. 4, in recognition of its achievements and continued contributions to regulatory science. CTTI was one of three recipients of the annual award.
“This great honor caps off a momentous year for CTTI,” said Pamela Tenaerts, CTTI executive director. “We celebrated our 10-year anniversary at the beginning of...
During a public webinar on Thurs., Nov. 15, CTTI released new recommendations that propose a fresh approach for investigator qualification. The webinar, now available online , explored how these new recommendations can move qualification activities beyond repetitive one-size-fits-all training to include individual experience and protocol-specific preparation.
While current FDA regulations state that sponsors and their delegates are responsible for selecting qualified investigators, no guidelines exist for how...
CTTI released new recommendations proposing a new approach for investigator qualification today during a public webinar. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.
While Good Clinical Practice (GCP) training is widely used as the industry standard for investigator qualification, there is little evidence that completion of GCP training alone sufficiently qualifies investigators and...
CTTI will release new recommendations that propose a new approach for investigator qualification during a public webinar on Thurs., Nov. 15. This approach goes beyond repetitive one-size-fits-all training and includes individual experience and protocol-specific preparation.
Current regulations from the U.S. Food and Drug Administration (FDA) require that sponsors and their delegates select qualified investigators. Good Clinical Practice (GCP) training is widely used as the...
