Release Date: June 29, 2012
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)
National Institute of Allergy and Infectious Diseases (NIAID)
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":
- Describe the processes of conducting interim and final analysis of clinical studies when necessary and requested.
- Describe the procedures for maintaining blinding for the duration of the study.
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:
- Are there strong, meritorious, appropriate and feasible plans and procedures for providing all statistical and data management services required, including: database design, security, confidentiality and administration; participant randomization/registration; data collection, quality control, data retrieval; and report generation?
- Do the senior/key personnel have adequate qualifications, time commitment, training, and experience?
- Is there an appropriate and clear organizational structure and management plan with lines of authority?
For Research Capacity (SDMC Component 4) reviewers will consider:
- Are there adequate, appropriate and feasible plans and procedures for conducting interim and final analyses of clinical studies and for strict maintenance of blinding throughout the study?
- Are the proposed procedures for planning and implementing cross-network protocols adequately defined, feasible and innovative?
- Are there scientifically and technically valid plans to evaluate new data management or statistical methods, procedures or tools, and approaches to validation?
For Communication and Collaboration (SDMC Component 5) reviewers will consider:
- Are there appropriate plans for collaborating and coordinating with DSMBs and external organizations, including outside sponsors and investigators?
- Do the plans for maximizing organizational efficiency and effectiveness take advantage of collaborations with other NIAID- and NIH-supported HIV/AIDS clinical trial networks and HANC?
- Do areas for collaboration include harmonization of network policies and procedures related to data management and identification of common data elements, data dictionaries, and data interfaces?
- Are there strong, meritorious, appropriate and feasible plans for rapid and effective communication?
WITH:
For Structure, and Governance (SDMC Component 3) reviewers will consider:
- Are there strong, meritorious, appropriate and feasible plans and procedures for the management and governance of the SDMC including decision making processes, for the evaluation and incorporation of novel statistical methods, developing a functional committee structure, and achieving cost efficiencies?
- Do the key senior/key personnel have adequate qualifications, time commitment, training, and experience; are there adequate plans for how the SDMC staff will interact with other parts of the network?
- Is there an appropriate and clear organizational structure and management plan with lines of authority?
For Research Capacity (SDMC Component 4) reviewers will consider:
- Will the described interactions with other parts of the network LG further the LG s scientific goals?
- Does the proposed SDMC sufficiently demonstrate the ability to: interact, assess capacity and receive data from the CTU/CRSs and other partners?
- Are there adequate procedures described to evaluate data collection, transmission, integrity between the SDMC and appropriate partners?
- Are there strong, meritorious, appropriate and feasible plans for the SDMC to provide and evaluate the training needs of the network members?
For Communication and Collaboration (SDMC Component 5) reviewers will consider:
- Are there appropriate plans for collaborating and coordinating with DSMBs and external organizations, including outside sponsors and investigators?
- Do the plans for maximizing organizational efficiency and effectiveness take advantage of collaborations with other NIAID- and NIH-supported HIV/AIDS clinical trial networks and HANC?
- Do areas for collaboration include harmonization of network policies and procedures related to data management and identification of common data elements, data dictionaries, and data interfaces?
- Are the proposed procedures for planning and implementing cross-network protocols adequately defined, feasible and innovative?
- Are there strong, meritorious, appropriate and feasible plans for rapid and effective communication?
All other aspects of the five FOAs remain the same.
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
and Human Services (HHS)
