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Skip Navigation Links4 - Conduct the AS

​Conduct the AS 

(after receiving funding)

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

Steps for conducting and completing an AS after the AS is funded.
1.  AS PI receives fundable score and Notice of Award (NOA) with funding dates and budget status.  Based on budget, the AS PI and Clinical Coordinating Center (CCC) renegotiate the CCC subcontract if necessary.
If there is a CCC subcontract, the following steps 2-4 can occur while waiting for the subcontract to be signed:
2.  PI sends the AS Institutional IRB documents to CCC and the CCC prepares and submits the FHCRC IRB application.
3.  PI signs the new WHI Data and Materials Transfer and Use Agreement (DMTUA), which outlines the data and/or biological specimens to be released to the PI and the relevant WHI policies with which the PI agrees to comply.
4.  PI works with CCC in preparing schedules and tasks. 
Biospecimen Studies: 
·        PI sends lab procedures to the CCC and works with the CCC Data Operations Technical Coordinator to determine biospecimen details.
·        PI and CCC begin discussions about sample selection criteria (e.g., case/control selection criteria).  This may be an iterative process involving the AS PI and Statistical staff, which depends on the funding level for this support.
·        The CCC estimates schedules for completing the sample selection, preparation of samples, and shipment are projected.  Pulling the biospecimens usually begins 4 months after the funding start date, and can vary depending on the contract requirements, subcontractor workload, and other factors. 
Recruitment Studies:
·        Mailing procedures and documents are developed and finalized, and mailing schedule is set. 
5.  Work on the AS proceeds after the subcontract with CCC is signed.
     If the AS requires CCC assistance, the CCC staff and PI work together to document activities, such as case/control selection, sample selection, etc.
     Timelines for obtaining specimens from WHI:
  • Biological Samples
    An Ancillary Study's timeline should assume that it may take up to four months for the WHI CCC to assemble the required data set of cases and suitable controls and to pull, aliquot, and ship biological samples. The post-award process is as follows:
    • Confirmation of a study's basic design and analyte testing plan & participant selection plan (Completion of a Specimen and Participants Questionnaire followed by one or more conference calls)
    • Final confirmation by the PI of a study's 'key facts' (Participant Selection Summary, Specimen/Pull Key Details documentation)
    • Sample Pull Creation by WHI CCC database
    • Sample Pull from the biorepository to the Specimen Processing Lab
    • Sample Processing by the Specimen Processing Lab
    • Shipment of samples to the testing lab
  • WHI QC Data
    When the testing lab has completed its testing, the testing lab or PI submits results to the WHI CCC. After test results are loaded into the WHI CCC database, the CCC prepares a Blind Duplicate Report and forwards the report to the PI for review.
     See Biospecimen and Data Flow Diagram for more details of flow of specimens and data when using biospecimens
 
6.  PI submits the AS data to the CCC.
ASs generating data of any kind (e.g., biospecimen assay results, new FFQ variables) must submit those data and data documentation to the WHI CCC for incorporation into the main study database before receiving access to phenotype/covariate data on the WHI web site.  Each funded AS has a WHI Study Site to which ASs can upload datasets and dictionaries, data preparation documentation, and other study-related materials.  Investigators also are encouraged to add information to the main study pages to briefly describe the AS and the findings.   
For all ancillary studies, see the Technical Guide for how to upload the AS data to the WHI web site. 
For biospecimen studies, also submit the lab data to the CCC after each batch or pull of samples has been tested.  See Guidelines for AS Biospecimen Data Submission.
 
7.  PI access to WHI Database

     The CCC will give an ancillary study PI the information needed (logon name and password) to access to the WHI database for 90 days after:
1) CCC has received all test results for a study,
2) PI has signed a Data Use Agreement (DUA), and
3) PI has an approved paper proposal (see the WHI Publication and Presentation (P&P) Policies).

     Using the WHI Common IDs and the WHI database access logon information, the ancillary study PI can download all remaining data needed for her/his analysis.  

 8. The PI must provide the CCC with a final analytic data set at the time of the primary publication from the AS or BAA. See Guidelines for AS Biospecimen Data Submission for guidelines on submitting these data.
     One year after the ancillary study’s end date and without notifying the study’s PI, WHI may release data generated by the ancillary study to qualified scientific investigators requesting access through established WHI procedures. WHI will encourage the scientific investigators requesting access to collaborate in analyses and publications with the PI who generated the data.
9.  WHI AS may be required to, or choose to, submit their data to dbGaP (database of Genotypes and Phenotypes) a central data repository at the National Center for Biotechnology Information (NCBI).  Submission is a condition of the funding agency in many cases.  WHI has specific limitations on the data that can be submitted based upon WHI participant consent.  Therefore, AS investigators submitting genetic data should work with the WHI-CCC and follow the steps outlined in the dbGaP Guidelines or Quick Information Sheet to ensure the data is submitted correctly.  Please contact the WHI-CCC with any questions or help using these guidelines.
 
10.   PI submits an Annual Progress Report form to the ASC each July.  See Report Template. The report should include the following:
a) Status of study (active, pending, completed, etc.),
b) Funding information,
c) Study activities during reporting period,
d) Number of participants involved,
e) Field centers involved, and
f) Findings to date.
 
 

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Quick Link to Documents included above:

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