Notice of Corrections to RFA-TR-14-009 "Clinical and Translational Science Award (U54)"
Notice Number:
NOT-TR-14-013
Key Dates
Release Date: October 30, 2014
Related Announcements
Issued by
National Center for Advancing Translational Sciences (NCATS)
Purpose
The purpose of this Notice is make six modifications for RFA-TR-14-009
1. Elimination of Line Incorrectly Duplicated
Part 2. Section IV.2. Content and Form of Application Submission
Current Language:
Instructions for the Submission of Multi-Component Applications
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
Overall: Required
Translational Science Base: Required
Administrative Core: Required
Translational Science Base: Required
Research Expertise and Methods: Required
Research Implementation and Participation: Required
Network Resources and Optional Modules: Required
Mentored Career Development: Required
NRSA Training Core: Optional
Revised Language:
Instructions for the Submission of Multi-Component Applications
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
Overall: Required
Administrative Core: Required
Translational Science Base: Required
Research Expertise and Methods: Required
Research Implementation and Participation: Required
Network Resources and Optional Modules: Required
Mentored Career Development: Required
NRSA Training Core: Optional
2. Revision of Requirement When a CTSA is Reviewing Proposed Pilot Studies
Part 2. Section IV.2. Content and Form of Application Submission
Research Implementation and Participation
Current Language
PHS 398 Research Plan (Research Implementation and Participation)
Applicants should describe their translational pilot program guidelines: addressing solicitation, review, prioritization, business and cost management, progress tracking, and program evaluation. The review must be rigorous and include an in-person meeting of a multi-disciplinary committee patterned after an NIH study section peer review process to ensure that pilot projects are of high methodological quality, and can answer important scientific question proposed
Revised Language
PHS 398 Research Plan (Research Implementation and Participation)
Applicants should describe their translational pilot program guidelines: addressing solicitation, review, prioritization, business and cost management, progress tracking, and program evaluation. The review must be rigorous and include a meeting of a multi-disciplinary committee patterned after an NIH study section during which pilot project reviewers interact as a group in real time to discuss the applications. This process will help to ensure pilot projects are of high methodological quality, and can answer important scientific questions proposed. Two-level reviews are allowed; a larger group of reviewers with specialized expertise may submit written critiques that are then considered by a smaller multidisciplinary group interacting in real time to make the final selections.
3. Correction of Instruction Regarding Prices
Part 2. Section IV.2. Content and Form of Application Submission
Network Resources and Optional Modules
Current Language
PHS 398 Research Plan (Network Resources and Optional Modules)
Under Research Strategy
Also, the study support unit will streamline budget preparation by establishing, updating, and posting for CTSA internal use the price of clinical research items (such as for example a chest X-ray, or a complete blood count). Applicants should describe one price per item, and as needed, a transparent price adjustment in the form of a discount for NIH studies, or a surcharge for industry studies to account for F & A differentials. This price inventory will facilitate and expedite the planning of clinical research.
Revised Language
PHS 398 Research Plan (Network Resources and Optional Modules)
Under Research Strategy
Applicants should describe their willingness to work with the CTSA network on streamlining the budgeting process for clinical research items. Applicants could provide examples of how they could determine or provide prices for investigators at their institution and within the CTSA network.
4. Modification of Type of Clinical Trial to Include in Table
Part 2. Section IV.2. Content and Form of Application Submission
Network Resources and Optional Modules
Current Language
PHS 398 Research Plan (Network Resources and Optional Modules)
Under Research Strategy
Metrics: Applicants should include a table with the application that contains a brief description of all clinical trials with site activation in the first half of 2013, showing time from contract received to execution, time from protocol received by the trial principal investigator (or time protocol finalized if local trial) to IRB approval, time from subcontract executed to first patient first visit, and time from IRB approval to first patient first visit.
Revised Language
PHS 398 Research Plan (Network Resources and Optional Modules)
Under Research Strategy
Metrics: Applicants should include a table with the application that contains a brief description of all NIH-defined Phase III clinical trials with site activation in the first half of 2013, showing time from contract received to execution, time from protocol received by the trial principal investigator (or time protocol finalized if local trial) to IRB approval, time from subcontract executed to first patient first visit, and time from IRB approval to first patient first visit.
5. Clarification of Tables Required
Part 2. Section IV.2. Content and Form of Application Submission
Current Language
Mentored Career Development
When preparing your application in ASSIST, use Component Type ‘Inst Career Dev’.
Relevant table shells can be found at the following link: https://grants.nih.gov/grants/funding/424/index.htm#data.
Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) applications except where indicated below:
Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.
Revised Language
Mentored Career Development
When preparing your application in ASSIST, use Component Type ‘Inst Career Dev’.
Relevant table shells can be found at the following link: https://grants.nih.gov/grants/funding/424/index.htm#data. Only Tables 2, 5B and 10 are required. Institutions that currently have an institutional K award funded by NCATS are encouraged to also provide Table 12B.
Follow all instructions provided in the SF424 (R&R) Application Guide for Preparing Institutional Ruth L. Kirschstein National Research Service Award (NRSA) applications except where indicated below:
Substitute the term “scholars” for all references to “trainees” in the SF424 (R&R) Application Guide, and substitute the term “career development” for all references to “training” in the SF424 (R&R) Application Guide.
6. Correction of Incorrect Email Address
Part 2. Section IV.6 Other Submission Requirements and Information
Current Language
In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at ncatsreferal@mail.nih.gov when the application has been submitted.
Revised Language
In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at ncatsreferral@mail.nih.gov when the application has been submitted.
All other aspects of this FOA remain unchanged.
Inquiries
Please direct all inquiries to:
Petra Kaufmann, M.D., M.Sc.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0178
Email: CTSAFOAQuestions@mail.nih.gov
