The FY22 TERP CTA is intended to support the rapid implementation of clinical trials with the potential to have a significant impact on the prevention, treatment, or management of symptoms, diseases, or conditions associated with or resulting from toxic exposures.

To meet the intent of the award

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mechanism, applications must address at least one of the FY22 TERP Programmatic Goals and at least one of the FY22 TERP Topic Areas.Proposed projects may range from small proof-of-concept clinical trials (e.g., pilot, first-in-human, phase 0) designed to demonstrate feasibility or inform the design of more advanced trials, through large-scale trials to determine efficacy in relevant patient populations.

Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies.

It is anticipated that outcomes from studies funded by this award will follow a clinical development plan that advances the research to FDA device or drug approval and/or establishment of clinical practice guidelines, as applicable.Applications to the TERP CTA mechanism must support a clinical trial and may not be used for animal or preclinical research studies.

The application will be withdrawn if the proposed research is not a clinical trial.