Effective date: 09/14/2017
ACTG NEW WORKS CONCEPT SHEET (NWCS)
PROPOSAL FORMAT
Instructions
The NWCS proposal must be no longer than 5 pages and in Arial 11–point font (preferably in Microsoft Word), and must be submitted electronically via the ACTG Proposal Submission System at All essential materials for review must be included within the page limit. NWCS reviewers may or may not choose to review supporting materials (e.g., published articles or data) attached as appendices.
Note: The term “participant” is to be used instead of “subject” or “patient” in all network studies, including NWCSs.
Proposal Format
STUDY TITLE:
Descriptive title of the proposed work.
VERSION NUMBER:
Indicate whether this is the original submission (version 1) or a revision (version 2, etc.).
SUMMARY OF MAJOR REVISIONS:
If the proposal is a revision (version 2 or higher), include a brief narrative of the major changes from the prior version (e.g., new relevant protocols, new or modified objectives, statistical resources, number of specimens, funding, etc.). Any new language in the subsequent sections should be in bold text to facilitate review by the ACTG.
PROPOSING STUDY CHAIR, VICE CHAIR(S), INVESTIGATOR(S) AND INSTITUTION(S):
Identify at least one investigator to serve as study chair. Indicate if the study chair is an ACTG investigator or non-ACTG investigator. A vice chair(s) may also be identified, if desired. Provide the name, title, institution/ACTG CRS, address, telephone, and e-mail address of the proposing investigator(s).
SDUA RESPONSIBLE PARTIES:
Identify the investigator(s) and/or statistician(s) who will complete the ACTG Specimen and Data Usage Agreement and receive the specimens/data.
COLLABORATING STATISTICAL AND DATA ANALYSIS CENTER (SDAC) STATISTICIAN:
Name, telephone number, and e-mail address of the collaborating SDAC statistician in those situations where SDAC will be performing the analyses and/or will have substantial scientific involvement.
COLLABORATING EXTERNAL STATISTICIAN(S):
Name, telephone number, and e-mail address of the collaborating statistician(s) in those situations where SDAC will not be performing the analyses.
COORDINATING SDAC STATISTICIAN (this may be blank at initial submission):
SDAC will provide the name, telephone number, and e-mail address of an SDAC statistician who will coordinate provision of data and samples for the approved NWCS if one is not among the proposing team members.
STUDY RATIONALE:
Complete, concise discussion of the new work rationale, including sufficient background information (e.g., data, references) to support the scientific merits and importance of the new work.
STUDY OBJECTIVE(S):
A clear and thorough description of all study objectives of the new work.
STUDY DESIGN:
A clear and thorough explanation of study design and analysis methods. Full description of how the critical research questions will be answered (including proposed sample analysis methods) and justification of all statistical components of the new work.
STUDY DURATION:
An estimated timeline to complete the new work.
RELEVANT ACTG PROTOCOL(S):
List of all ACTG protocols that are pertinent to the research questions.
DATA MANAGEMENT AND DATA ANALYSIS:
Responsible party for both data management and analysis (SDAC, drug company, institution), and specific variables and associated case report forms (CRFs) required for the analysis.
POSTING OF GWAS DATA TO THE NIH DATABASE OF GENOTYPES AND PHENOTYPES OR dbGaP:
Any NWCS involving genome-wide association studies (GWAS) data must contain a section addressing NIH Policy NOT-OD-07-088 and related policies, including a statement in the NWCS that only consented GWAS will be posted to dbGaP and which statistical group (SDAC or the investigators’) will perform the posting.
RESOURCES:
Estimated SDAC statistical, programming, and data management time required to provide the specimens/data and, where relevant, conduct the analysis. Where relevant, identify time required at ACTG sites (e.g., for procuring specimens or abstracting associated clinical data).
SAMPLES REQUIRED:
Number of participant samples for each sample type (serum, plasma, other bodily fluids, and tissues); sample timing (pre-drug, while on drug, endpoint) and sample quantity; and the statistical rationale for these requirements.
EXISTING SAMPLE INVENTORY:
Location (CRS) and total quantity of each type of required sample.
SPECIMEN REPOSITORY WEBSITE:
Indicate with an “X” whether you used the ACTG/IMPAACT Specimen Repository Website ( to identify participant samples pertinent to the research questions.
Yes ______No ______
LABORATORY TESTING SITE(S):
Identification of the laboratory(ies) that will be performing the analyses.
ESTIMATED COST(S):
Assay costs, personnel costs, etc.
EXTERNAL SUPPORT/COLLABORATION/FUNDING:
If known, discuss any anticipated collaboration with and/or funding support from industry or other programs or institutes within the NIH.
Note: If this NWCS will also be submitted for consideration for an NIH grant, there must be at least 6 weeks between submission of this NWCS and the grant application deadline. For more information, refer to SOP ACTG-152, ACTG-Related Grant Applications and Letters of Support.
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SIGNATURE of Proposing Study ChairDATE
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SIGNATURE of ACTG CRS Leader (if applicable)DATE