NIH Requirements

NIH Requirements for Grants and Contracts

NIH is launching a series of initiatives that are rolling out in 2017-2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the whole clinical trial lifecycle from concept to results reporting. Learn more about these changes and how they will affect your research at http://osp.emory.edu/nih_clinical_trial_requirements/index.html.

NIH Template Language

Below are the template language for NIH Clinical Trials:

NEW COMPETING CLINICAL TRIALS:
(New applications submitted on or after January 18, 2017)

  • ClinicalTrials.gov (must include this heading)

The proposed project will require registration in ClinicalTrials.gov.  Registration information will be submitted within 21 days of enrollment of the first subject and summary results information will be reported within one year of the primary completion date. 

  • (Add to the Budget Justification section for new or competing applications submitted on or after January 18, 2017)

    ClinicalTrials.gov ($3,500)

    $3500 is requested for the support needed to facilitate the registration, periodic updates, and results reporting within ClinicalTrials.gov for the duration of the study.

PROGRESS REPORTS ON NIH CLINICAL TRIALS:
(New or competing applications submitted on or after January 18, 2017)

  • ClinicalTrials.gov (must include this heading)

The following project is registered in ClinicalTrials.gov:  Insert ClinicalTrials.gov registry number (NCT#), the brief title listed in ClinicalTrials.gov, and the responsible party’s name, organization, and email address.