Organizations must submit applications to (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH's electronic system for grants administration. NIH and systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
For instance, comparing an investigatorinitiated, observational trial to an industry-sponsored, premarket interventional trial illustrates how this framework might be used to qualify a PI. As depicted right, the competencies for the Study and Site Management Domain are identical in the two different styles of trial, but not so for the Scientific and Research Design Domain. This does not imply that a less competent investigator can perform an observational study, but that a lower level of competency is required for that study method. Furthermore, the level of competency might be quite different for other clinical research team roles, such as CRC, CRA, data manager, or regulatory affairs coordinator.
Significance: The significance of the proposed clinical trial and importance of the research question must be clearly stated. It is particularly important that there be a discussion of how the trial will test the proposed hypotheses and why there is clinical equipoise. The application should make clear the need for and timeliness of the study with emphasis on how the results will address an evidence gap and therefore advance our knowledge of theory and practice in this area. Include a description of how results will impact clinical care to improve health. A discussion of the costs and benefits of the study should be included for evaluation of the trial's significance.