As per NIH’s policy, investigators and clinical trial staff are expected to maintain their GCP training through refresher courses every three years. For more information read the NIH Guide notice announcing the policy and other related FAQs. Continue reading
Institutions need not regard the NIH Good Clinical Practice (GCP) policy’s effective date as a deadline by which we expect NIH-funded investigators and clinical trial staff involved in the design, conduct, oversight, or management of clinical trials to complete GCP training. Rather, as long as steps are being taken to meet the expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be completed after the effective date. For more information, …. Continue reading
The GCP policy does not specify that a particular GCP course or program be taken. The policy includes links to GCP training courses sponsored by NIAID and NIDA. In addition, NCATS has developed a GCP training program geared to behavioral clinical trial investigators. These courses are free of charge. Other free courses as well as fee-based courses are available.
For more information read the NIH Guide notice announcing the policy and other related FAQs. Continue reading
With the exception of grant programs that have an effort requirement, or where terms and conditions prohibit such reductions, NIH will not require prior approval for the reduction in effort for Senior/Key personnel named in the Notice of Award (NoA) during a no-cost extension. However, consistent with the NIH Grants Policy Statement Chapter 126.96.36.199, recipients are reminded that for active NIH awards, the PD/PI and other Senior/key personnel named in the NoA must devote a measurable level of effort. Continue reading
Yes, the PD/PI and other Senior/key personnel named in the notice of award must devote a measurable level of effort to the project. If the level of effort is reduced by 25 percent or more from what was approved in the initial competing year award, prior approval from NIH would be required. (See NIH Grants Policy Statement Chapter 188.8.131.52). With the exception of grant programs that have an effort requirement, or where terms and conditions prohibit such reductions, NIH does not require prior approval for the reduction in effort for Senior/key personnel named in the notice of award during a no-cost extension. Continue reading
The authentication plan is only for established key biological and/or chemical resources, as defined on our website. Do not include plans for the authentication of data sets, databases, machinery, or electronics in the authentication plan attachment. If the Research Strategy does not propose use of key biological and/or chemical resources, the …. Continue reading
The authentication plan should be provided as a separate attachment (Item 15 in the Research Plan). The plan should be brief (no more than one page is suggested), and it should include a description of the methods proposed to authenticate key biological and/or chemical resources prior to use and at regular intervals, if appropriate. Key resources and the methods for authentication will vary by research field. …. Continue reading
If you’re currently a grantee, there are two paths for seeking additional funding for an active project, depending on the project needs. ….
If remembering the difference between a renewal and a revision has you stumped, we have a page on types of applications that can help. Knowing what type of application you are submitting is important for a number of reasons. …. Continue reading
Principal investigators with an Internet Assisted Review (IAR) role — i.e. current and former reviewers — can check if they are eligible for continuous submission of their applications (being allowed extra time to submit and bypassing standard due dates) by going to their Personal Profile in eRA Commons …. Continue reading