Effective date: 07/21/2015
ACTG NEW WORKS CONCEPT SHEET (NWCS)
PROPOSAL FORMAT
The NWCS proposal must be no longer than 5 pages and in Arial 11–point font (preferably in
Microsoft Word), and should be submitted electronically via the ACTG Proposal Submission
System at https://submit.actgnetwork.org/ or to the ACTG Network Coordinating Center
Proposals Coordinator at ACTGProposals@s-3.com. 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.
STUDY TITLE:
Descriptive title of the proposed work.
VERSION NUMBER:
Indicate whether this is the original submission (version 1.0) or a revision (version 2.0, etc.).
SUMMARY OF MAJOR REVISIONS:
If the proposal is a revision (version 2.0 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. A vice chair(s) may also be identified, if
desired. Provide the name, title, institution address, telephone, and e-mail address of the
proposing investigator(s) and clinical research sites (CRSs).
COLLABORATING STATISTICAL AND DATA ANALYSIS CENTER (SDAC) STATISTICIAN(S):
Name, telephone, and e-mail address of the collaborating SDAC statistician(s) in those
situations where SDAC will be performing the analyses and/or will have substantial scientific
involvement.
COLLABORATING EXTERNAL STATISTICIAN(S):
Name, telephone, and e-mail address of the collaborating statistician(s) in those situations
where SDAC will not be performing the analyses.
COORDINATING SDAC STATISTICIAN (This should be blank at initial submission):
SDAC will provide the name, telephone, and e-mail address of an SDAC statistician who will
coordinate provision of data and samples for approved NWCS where there is no Collaborating
SDAC Statistician.
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.
Effective date: 07/21/2015
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, CRS), 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
(www.specimenrepository.org) 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., and any external funding sources.
Effective date: 07/21/2015
EXTERNAL SUPPORT/COLLABORATION/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 is being submitted PRIOR to the NIH grant application submission, the grant
application receipt date must be no later than 6 weeks prior to submission of this NWCS.
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SIGNATURE of Proposing Investigator(s)
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DATE
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SIGNATURE of CRS Leader
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DATE