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Steps Prior to the Implementation of NIDCD U01 Clinical Trials

Before you begin implementing your clinical trial, please remember that:

  • Principal Investigators (PI) receiving NIDCD funding to conduct a clinical trial will have primary responsibility for stewardship of the clinical trial.
  • The ethical conduct of clinical trials involving human participants starts with the development of a well-designed trial and continues through the timely and successful completion of a high-quality, scientifically valid trial that can inform future clinical practice.
  • Stewardship to mitigate risks related to a clinical trial must be comprehensive.
    • Safety risks to clinical trial participants related to study interventions or procedures are always a priority. This includes inclusion of the most appropriate participant population, strong safety and efficacy justification for intervention as well as the selected dose(s), incorporation of procedures to mitigate safety risks and diligent monitoring of adverse events.
    • You must also be vigilant in mitigating other important risks related to the implementation of clinical trials, including factors such as the diversion from effective therapies for study participants, participant time commitment, financial risks related to the responsible use of federal funds, risks associated with inconclusive results, and risks associated with ineffective project completion, such as lost scientific opportunity.
  • For NIDCD U01 high-risk clinical trials, members of the NIDCD Clinical Trials Program (CTP) team will provide scientific/technical expertise, working in partnership with PIs and sharing the goals of advancing promising interventions through implementing high-quality clinical trials that advance beneficial interventions into practice and make them accessible to the patients who need them.

NIDCD U01 Clinical Trials: Pre-Implementation Requirements and Targets Timeline

The NIDCD U01 Clinical Trials Pre-Implementation Requirements and Targets Timeline (PDF | 707 KB) will help you understand the required tasks and completion targets prior to implementing a U01 clinical trial. These pre-implementation activities should be completed within 9 months of receiving the official Notice of Grant Award (NGA). PIs are encouraged to begin addressing these activities even prior to receipt of the NGA. The deliverables on the timeline are reportable to the NIDCD CTP team.

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