Errors in published Notice RFA-CA-24-025
1. Section III.3 Additional Information on Eligibility. Number of Applications Permitted
The RFA currently has contradictory information that applicant organizations may submit one or more than one application. Only one application per institution is allowed.
2. Section IV.2 Application and Submission Information, Clinical Trial Auditing Unit Budget
In the RFA in this section, the 3rd bullet currently says: “For intermediate and low-risk trials (e.g., FDA approved agent, over the counter medication or supplement, agent with low toxicity profile), follow-up audits will be conducted every 3 years on >50% of AOs meeting the accrual threshold (≥3 participants).”
3. Section IV.2 R&R Budget, Restricted Funds for Support of Young/Emerging Investigators
Funds for support of young/emerging investigators should be included for years 1 through 6, not years 1 through 5.
Question Posted: 09/30/2024
Is a Plan for Enhancing Diverse Perspectives (PEDP) required? The PI Responsibility section indicates that PD(s)/PI(s) will have the primary responsibility to:
• Provide updates at least annually on progress in PEDP implementation.
A PEDP is not required for this RFA. The PI responsibility language was automatically inserted but the RFA instructions did not ask for a PEDP and thus it should not be included.
Question Received: 09/22/2024
Should the attachments include only the projects in the past 5 years, say since November 2019 (project end date), or the projects with publications in the past 5 years? Ie. what if a project ended in 2018 or even before but there have been publications since then that fall in the 5 yr. window?
In the attachments, we are looking for projects that were active in the last 5 years, although they could be projects that started earlier and finished at any point during that time frame (e.g., finished in Nov or Dec of 2019). We are not looking for publications from older projects that happened to be published during the recent 5-year time frame (your prior experience and publications can be listed elsewhere).
Questions Received: 08/27/2024 (at Informational Webinar)
- What is the primary difference between what the DMASC will do compared with what the DMACC is doing now?
- The difference is primarily in the statistical support that DMASC will be providing. While we always envisioned DMACC providing statistical support/consultation to the Sites, it has become clear that this effort is scientific in nature and it has increased considerably with the performance of cross network trials (3 of which are currently ongoing, more are anticipated). We recognize the scientific nature of this input and therefore a UG1 scientific mechanism is more appropriate than the U24 infrastructure mechanism.
In terms of the infrastructure that DMACC currently provides (database, education, auditing, coordination, etc.), there is no significant change. - Do Medidata Rave services count toward Direct funds per year caps?
- Yes, Medidata Rave services come out of Direct funds, there is no other pot of money to draw from.
Question Received: 08/14/2024
Is the Restricted Funds for Support of Young/Emerging Investigators for years 1-5 or 1-6?
Answer: It is for years 1-6, there is an error in the RFA.
Last modified: 09/30/2024