Key Dates
October 18, 2024
Related Announcements
- August 16, 2024 - Pediatric HIV/AIDS Cohort Study (PHACS) (U19 Clinical Trial Not Allowed). See NOFO RFA-HD-25-003.
Issued by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Purpose
The purpose of this Notice of Clarification is to alert potential applicants to the “Pediatric HIV/AIDS Cohort Study (PHACS) (U19 Clinical Trial Not Allowed)” instructions regarding the elements to be included in the Scientific Administrative Core (SAC) or Data Management and Analysis Core (DMAC). To allow the greatest flexibility for applicants the following text and bullets may be included and addressed either in the Scientific Administrative Core (SAC) or Data Management and Analysis Core (DMAC) part of the application.
The SAC or DMAC will bring necessary expertise and resources for collaborative protocol development that will ensure feasible and acceptable study design(s), with proven ability to recruit and retain these unique populations through 5-15 competitive subcontracts to clinical sites with demonstrated high level prior performance.
- Execute and manage subcontracts for collaborating partners and clinical sites
- Provide support to the single IRB (sIRB) process and regulatory and compliance management for clinical sites.
- Utilize its relationship with and direct access to clinical sites, personnel, including Clinical Investigators, Study Staff and Community Board (CB) members, to implement all Research Projects and manage and monitor performance efficiently and effectively.
The aforementioned text and bullets were omitted from the SAC and DMAC and now should be added to: Section I. Notice of Funding Opportunity Description and Section IV. Application and Submission Information of RFA-HD-25-003.
Essential Features of the U19 Structure
Scientific Administrative Core (SAC) (required)
Currently, reads:
The SAC will bring necessary expertise and resources for collaborative protocol development that will ensure feasible and acceptable study design(s), with proven ability to recruit and retain these unique populations through 5-15 competitive subcontracts to clinical sites with demonstrated high level prior performance.
Modified to Read: (in bold italics)
The SAC or DMAC will bring necessary expertise and resources for collaborative protocol development that will ensure feasible and acceptable study design(s), with proven ability to recruit and retain these unique populations through 5-15 competitive subcontracts to clinical sites with demonstrated high level prior performance.
The SAC will
- Execute and manage subcontracts for collaborating partners and clinical sites
- Provide support to the Single IRB (sIRB) process and regulatory and compliance management for clinical sites.
- Utilize its relationship with and direct access to clinical sites, personnel, including Clinical Investigators, Study Staff and Community Board (CB) members, to implement all Research Projects and manage and monitor performance efficiently and effectively.
Data Management and Analysis Core (DMAC) (required)
Currently, reads:
The DMAC will:
- Execute and manage subcontracts for collaborating partners and clinical sites
- Provide support to the single IRB (sIRB) process and regulatory and compliance management for clinical sites.
- Utilize its relationship with and direct access to clinical sites, personnel, including Clinical Investigators, Study Staff and Community Board (CB) members, to implement all Research Projects and manage and monitor performance efficiently and effectively.
- Serve as the centralized data and resource management entity.
- Provide sample tracking, manage sample storage, oversee laboratory data management and data storage and access.
- Oversee and execute the sharing and transfer of samples and data and the receipt of data for collaborations.
- Provide programming and analytical core services for integrated data analysis.
- Serve as a shared resource to all Cores and Research Projects.
Modified to read: (in bold italics)
The SAC or DMAC will bring necessary expertise and resources for collaborative protocol development that will ensure feasible and acceptable study design(s), with proven ability to recruit and retain these unique populations through 5-15 competitive subcontracts to clinical sites with demonstrated high level prior performance.
The DMAC will:
- Execute and manage subcontracts for collaborating partners and clinical sites
- Provide support to the single IRB (sIRB) process and regulatory and compliance management for clinical sites.
- Utilize its relationship with and direct access to clinical sites, personnel, including Clinical Investigators, Study Staff and Community Board (CB) members, to implement all Research Projects and manage and monitor performance efficiently and effectively.
- Serve as the centralized data and resource management entity.
- Provide sample tracking, manage sample storage, oversee laboratory data management and data storage and access.
- Oversee and execute the sharing and transfer of samples and data and the receipt of data for collaborations.
- Provide programming and analytical core services for integrated data analysis.
- Serve as a shared resource to all Cores and Research Projects.
All other aspects of the NOFO remain the same.
Additionally, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will host an informational webinar to provide advice and respond to questions from prospective applicants to RFA-HD-25-003 “Pediatric HIV/AIDS Cohort Study (PHACS) (U19 Clinical Trial Not Allowed).”
The pre-application webinar will cover the above clarification of Instructions and include an overview of the notices of funding opportunity (NOFO) and other requirements for applications submitted in response to RFA HD-25-003. The webinar will conclude with an open question and answer session.
Webinar Information
Date: Thursday, November 7, 2024
Time: 4:00 PM, Eastern Daylight Time (EDT)
Please click this URL to join the meeting:
Join ZoomGov Meeting
https://nih.zoomgov.com/j/1609141718
Meeting ID: 160 914 1718
+16692545252,,1609141718# US
Participation in the webinar, although encouraged, is optional and is not required for the submission of an application. Advanced registration is not required.
Inquiries
Please direct all inquiries to:
Denise Russo, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6871
Email: [email protected]
Samantha Calabrese, M.P.H.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-7568
Email: [email protected]
Sai Majji, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-8048
Email: [email protected]
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