Modification: Updates to HIV/AIDS Clinical Network Leadership Group (LG) Statistical and Data Management Center (SDMC) Components, Review Criteria and Additional Review Criteria for RFA-AI-12-001, RFA-AI-12-004, RFA-AI-12-008, RFA-AI-12-011 and RFA-AI-12-012


Notice Number:  NOT-AI-12-036

Key Dates

Release Date:  June 29, 2012

Related Notices

RFA-AI-12-001 Leadership Group for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations (UM1)
RFA-AI-12-004 Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults (UM1)
RFA-AI-12-008 Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1) 
RFA-AI-12-011 Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection (UM1) 
RFA-AI-12-012 Leadership Group for a Clinical Research Network on Vaccines to Prevent HIV Infection (UM1)

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice is to inform the extramural research community of the replacement of instructions in the above five Leadership Group Funding Opportunity Announcements for the following Sections: Section IV. Application and Submission Information, Part C. Instructions Specific for the Statistical and Data Management Center (SDMC) Application; and Section V. Application Review Information, Part C. Statistical and Data Management Center (SDMC) Review Criteria with the following:

The table in Section IV, Part C. Instructions Specific for the Statistical and Data Management Center (SDMC) Application is replaced with the following table which has the addition of two rows for the

Biographical Sketch and Resources:

ITEM

Application 3: Statistical and Data Management Center (SDMC)

Copy of Application Package Cover Letter

Face Page – SDMC (PHS 398 Form, Page 1).  This is the first page of the SDMC application; number all succeeding pages consecutively.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cell statement if applicable(Form Page 2).  Make sure the abstract describes how the proposed components will contribute to the SDMC objectives.

Detailed Budget for First Year (use PHS 398 Form Pages 4)

Proposed budgets should be for CORE cost only,  not to include any protocol cost (PF)

Composite Budget for All Years of Proposed Period of Support (use PHS 398 Form Page 5 and continuation pages of Form Page 5)

A separate page of Detailed Budgets for Consortium Agreements to be summed as a line item on page 4

Biographical Sketch (Biographical Sketch Format Page). Provide biographical sketches of all senior/key professional personnel for all SDMC components at the end of the application. Place PD(s)/PI(s) biographical sketch(es) first, followed by those of other senior/key personnel in alphabetical order.

Resources (Resources Format Page).  Complete the resources available for each component.

Note:  For each component below, include a Cover Page and other information as described under detailed component headings.  Do not use Form Page 1

LOC, LC and SDMC Component 1.  Leadership Group Overview

SDMC Component 2:   Methodologies and Technical Capabilities

SDMC Component 3:  Structure and Governance

SDMC Component 4:  Research Capacity

SDMC Component 5: Communications and Collaborations

Resource Sharing Plan

Appendix

Checklist


Section IV, Application and Submission Information

     Part C. Instructions Specific for the Statistical and Data Management Center (SDMC)   Application

          SDMC Component 2.  Methodologies and Technical Capabilities,

               Data Management Plans and Systems:

The following two bullets are added after the bullet: "Describe procedures used for study randomization, randomization systems supported (web-based allocation, touch tone allocation, permuted block allocation, etc.), procedures for verification and validation of eligibility prior to randomization":

Section IV, Application and Submission Information

     Part C. Instructions Specific for the Statistical and Data Management Center (SDMC) Application

        SDMC Component 5.  Communications and Collaborations

REPLACE:

Inter-Network Collaborations.  (i) Discuss approaches for working cooperatively with other NIAID and non-NIAID-funded networks and HANC to harmonize data collection processes across networks, and develop and implement standard data interfaces, commonly defined variables, and common data elements.  (ii) Identify methods for minimizing costs and avoiding redundancies.  (iii) Discuss the capacity and willingness of the SDMC to assist other clinical trial networks and to provide training to SDMC personnel from other networks, if needed.

WITH:

Inter-Network Collaborations.  (i) Discuss approaches for working cooperatively with other NIAID and non-NIAID-funded networks and HANC to harmonize data collection processes across networks, and develop and implement standard data interfaces, commonly defined variables, and common data elements.  (ii) Identify methods for minimizing costs and avoiding redundancies.  (iii) Discuss the capacity and willingness of the SDMC to assist other clinical trial networks in implementing cross-network protocols and to provide training to SDMC personnel from other networks, if needed.

Section V. Application Review Information

     C.  STATISTICAL AND DATA MANAGEMENT CENTER (SDMC) REVIEW CRITERIA

          Scored Review Criteria - Methodologies and Technical Capabilities (SDMC Component 2)

Under Approach, add the following criteria section as the second paragraph:

Are there adequate, appropriate and feasible plans and procedures for conducting:  randomization, interim and final analyses of clinical studies and for strict maintenance of blinding throughout the study yet fully respond to DSMB requests for interim data by study arm?

Are there scientifically and technically valid plans to evaluate and adapt new data management or statistical methods, procedures or tools, and approaches to validation?

Section V. Application Review Information,

     C.  STATISTICAL AND DATA MANAGEMENT CENTER (SDMC) REVIEW CRITERIA

          Additional Review Criteria – SDMC Components 3-5

REPLACE:

For Structure, and Governance (SDMC Component 3) reviewers will consider:

For Research Capacity (SDMC Component 4) reviewers will consider:

For Communication and Collaboration (SDMC Component 5) reviewers will consider:

WITH:

For Structure, and Governance (SDMC Component 3) reviewers will consider:

For Research Capacity (SDMC Component 4) reviewers will consider:

For Communication and Collaboration (SDMC Component 5) reviewers will consider:

All other aspects of the five FOAs remain the same.

Inquiries

Please direct all inquiries for:

RFA-AI-12-001 Leadership Group for a Clinical Research Network on HIV/AIDS and HIV-associated Infections in Pediatric and Maternal Populations (UM1)

to

Judi Miller, BSN
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5227, MSC-7624
6700B Rockledge Drive
Bethesda, MD 20982-7624 (for Express Mail- 20817)
Telephone:  301-496-1189
FAX:  301-480-4582
Email: jmillera@niaid.nih.gov

RFA-AI-12-004 Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV-associated Infections in Adults (UM1)

to

Ellen DeCarlo, BSN
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5229. MSC-7624
6700B Rockledge Drive
Bethesda, MD 20982-7624(for Express Mail- 20817)
Telephone: 301-496-8212
Email: decarloe@niaid.nih.gov

RFA-AI-12-008 Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1)

to

Roberta Black, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5117, MSC-7624
6700B Rockledge Drive
Bethesda, MD 20982-7624(for Express Mail- 20817)
Telephone:  301-496-8199 (office)
FAX: 301-402-3684
Email: rblack@niaid.nih.gov

RFA-AI-12-011 Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection (UM1)

to

Mike Gilbreath, Ph.D.
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5249, MSC-7620
6700B Rockledge Drive
Bethesda, MD 20982-7624(for Express Mail- 20817)
Telephone: 301-451-2743 (office)
Email: gilbreathmj@niaid.nih.gov

RFA-AI-12-012 Leadership Group for a Clinical Research Network on Vaccines to Prevent HIV infection (UM1)

to

Philip Renzullo, Ph.D., MPH
Division of AIDS
National Institute of Allergy and Infectious Diseases (NIAID)
Room 5132, MSC-7624
6700B Rockledge Drive
Bethesda, MD 20892-7624 (for Express Mail – 20817)
Telephone: 301-451-2764 (office)
FAX: 301-402-3684
Email: prenzullo@niaid.nih.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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