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Skip Navigation Links4 - Conduct the AS

 After proposal has been approved and is funded:

Steps for conducting WHI approved and funded ancillary studies

Biospecimen studies:

​PI Responsibilities ​CCC Responsibilities
Send Notice of Award (NOA) and an "intent to fund the subaward" email to the WHI CCC  
Sign WHI DMTUA* (right-click and select "Save as" to save form to your PC) 
Seek Institutional IRB ApprovalSeek Fred Hutch IRB Approval
Issue subaward* 
 Email participant and specimen details questionnaire to PI
Complete participant and specimen details questionnaire and return to CCC 
 Schedule Kick off call with PI
 Conduct participant selection
 Draft final documents and send to PI
Confirm sample specs and sign off on final documents 
 Program pull files
 Pull and sort specimen at biorepository
 Ship to Specimen Processing Lab (SPL)
 Ship processed samples to testing lab
Return lab data to CCC 
 Incorporate results into WHI database

Submit P&P Paper Proposal (right-click and select "Save as" to save form to your PC) (Note: this can be completed earlier to avoid delays in data access)

Prepare QC report
After paper proposal is approved (and data have been returned to the CCC), sign Data Use Agreement (DUA) to receive access to WHI investigator WebsiteLink lab data to WHI Common ID and Case/Control Status
 Provide linkage and log on credentials to PI for 90 day access to download remaining data needed
Complete Annual Progress Reports (yearly) 
Provide CCC with Final analytic data set at time of primary publication 
 Release data generated by AS (one year after the AS's end date and without notifying study PI, WHI may release data generated by AS to qualified scientific investigators requesting access through established WHI procedures)


*Samples cannot be released until these documents are executed

For all other types of studies, including non-specimen data collection studies, please contact the CCC AS coordinator listed in your ASC-approval letter for guidance or send questions to the WHI Help Desk at helpdesk@whi.org.


PLEASE NOTE: If there is any change to your study (including aims, sample size or assays) at any time after submission to the ASC for review, an AS Modification Request form needs to be submitted to ASC for approval. Please email form to helpdesk@whi.org.

  • AS Study site pages: Most funded AS have a Study Page, which contains a brief description of the study, including specific aims. When AS data is eligible for release, it may be linked to the study site page along with data dictionaries, data preparation documentation, participant selection description and other study-related materials.

  • 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.  The actual submission is the PI's responsibility.  Please contact the WHI-CCC at helpdesk@whi.org with any questions or help using these guidelines.