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Skip Navigation Links3 - Prepare AS Budget

​​Prepare AS Budget 

(after receiving WHI approval)

AS Quick Links: AS Overview; Propose an Ancillary Study; Prepare AS Budget; Conduct the AS

Steps to apply for funding of an Ancillary Study (AS) in WHI.

1..   Contact the Clinicial Coordinating Center (CCC) Administrative person listed in your Ancillary Study Committee (ASC) letter to determine if a CCC subcontract or purchased service is needed.  In general, an AS planning to contact current participants at a single Regional Center or to use only scientific support does not need CCC involvement.  A CCC subcontract is needed for the following types of services:
·        Biospecimen access
·        Participant recruitment and consent across Regional Centers
·        Collection of new data
·        Access to confidential data available only in data enclave, e.g., CMS or geocodes (a purchase service may be possible)
·        Data analyses 
2.  Complete the CCC Intake Form and forward to the CCC Administrative Project Coordinator at least 2 months before submission for funding is planned. 

3.  The CCC will prepare an initial budget for the CCC portion of the AS, including a CCC work scope, budget, and budget justifications, and forward these to the PI for review. The work scope and budget depend on the type of services requested.

Requirements for subcontract:
·      All CCC support for AS services must be covered by Ancillary Study funds.
·      Each CCC subcontract is required to have a WHI investigator as subcontract PI, who will be responsible for the scientific oversight at FHCRC.
·   Be sure the funding agency of choice is willing to cover the FHCRC indirect cost rate of 76% since this rate is non-negotiable, or procure the difference from your institution.  Some non-profit organizations have limits on the amount of indirect costs.  (See Step 5 below.)
The work scope and budget depend on the type of services requested (see below).  See a sample work scope, budget, and budget justification for a biospecimen ancillary below:

    Recruitment studies: the WHI database supports AS consenting and enrolling of a participant. The AS is responsible for tracking and other types of data support.

·      ASs proposing contacting participants must use the CCC or Regional Center to make the initial contact.  Only the CCC or RC where the participant is currently enrolled can send out the initial contact letter.
·      See procedures for the initial contact and follow-up in the WHI Manuals, Section 7.7.5- Details on Obtaining Consent, which are similar for any AS wishing to mail to or contact participants.
Access to confidential data and/or request for the CCC to perform data analysis: The CCC has established a virtual data enclave (VDE) that allows investigators located across the US to remotely access and statistically analyze confidential data on a secure server located at the CCC. The confidential data includes:
·      Dates of residence with latitude, longitude, FIPS code, and zip code of residence since being entered into the WHI database and other location data; participant vital statistics, which includes date of birth and date of death.
·      Participant medical history and medical services use from Medicare data linkage, the National Death Index and any other data linkage activities that may be approved and conducted in the future.

        ·      Other participant study-related information such as dates of enrollment/randomization, dates of consent, and dates of participant contact for collection of data and specimens.  

Specific data excluded from the VDE includes: participant name, residential street addresses, phone numbers, and social security number.  See VDE for more information.
4.  Submit the grant application for funding, including CCC subcontract, and inform CCC of the submission date.
     AS Funding agencies/limitations   The FHCRC F&A rate of 76% is non-negotiable.
·      For small foundations or training grants with limits to F&A rates, the investigator's own institution must agree in advance to cover the difference between the capped rate (often 10-20%) and the FHCRC rate of 76% for the subcontract budget. FHCRC F&A rate is non-negotiable.
·      K-awards, other career development awards, and foundation awards are not well suited for WHI subcontracts. The funds often can not support faculty salary, and only cover a low F&A rate.
5.  Keep the CCC informed of funding status.
·      If funded, contact the  CCC to finalize the CCC subcontract. See Conduct the Study.
·      If not funded, inform the CCC if a resubmission is planned, along with date of resubmission.
6.  Complete an AS Annual Progress Report regardless of funding status, and send to the CCC each August. 
7.  Complete an AS Modification Requeset form for any changes requested after initial approval. Changes include changes in design; biospecimen analytes; type, number, and volume of biospecimen samples; study population, etc.

Next:  Conduct the AS


Quick Link to Documents included above: