· DUE DATE: Application materials are due by the 1st business day of the month.
· SUBMIT TO: . Refer to http://www.whi.org for Application Procedures Guide and other useful information.
WHI ANCILLARY STUDY APPLICATION FORM
To submit a WHI Study proposal for review, complete this form and attach a proposal narrative (not to exceed
12 pages, including tables/figures), consent form (if required), and study questionnaires (if required). If proposing a biospecimen study, include in the narrative details about the reliability of the lab assay(s) and the selected lab’s proficiency with each assay.
Note: All materials should be reviewed and approved by the Sponsoring WHI PI before submission to the WHI Ancillary Study Committee (ASC).
Today’s Date: Is this a re-submission? Yes No
1. Study Principal Investigator
Name:
Phone: Fax: Email:
Institution:
2. Sponsoring WHI PI (if different from Study PI): Sponsoring PI Institution:
3. Study Title:
4. Is this a collaborative or a consortium study? (A consortium project is a formalized agreement whereby a multi-study or cohort research project is carried out by two or more academic institutions or performance sites.)
No
Yes Complete the WHI Consortium Project Application Form. (Prior to ASC review, this study will require WHI Scientific Resources Working Group [SRWG] initial review and approval. NOTE: This step takes additional time (~3 weeks) so consider this when planning for ASC review and funding submission.
What other agencies and/or cohorts are involved?
5. Specific Aims:
6. Do you plan to submit genetic data into any genetic repository database (dbGaP, caBIG, etc.)? No Yes
(Oftentimes this is a requirement for the funding agency)
7. Expected time period for study: from to (dates).
8. Please indicate the number of participants and participant specimens (for biospecimen studies) you are requesting. If applicable, please specify the number requested for each WHI cohort.
Total Number of: / Number/Type of Cases / Number of Controls / Specific cohort(s) if applicable(e.g., OS, CT*, BMD, MRC/
SRC, LILAC, NPAAS, LLS, etc.) / Notes
Participants / Specimens
* If it matters which Clinical Trial (CT) arm (HRT, DM, CaD) please specify.
9. What existing WHI data or specimens will be used? (Check all that apply.)
Questionnaire data, physical measures, etc. à Skip to Q 10
WHI core blood analyte data à Skip to Q 10
WHI blood, DNA, or urine specimens à Complete specimen table below.
Other: à Skip to Q 10
Complete only if requesting WHI biospecimens; otherwise, go to Q 10.
Type of Specimen / N of samples / Amount Required(including padding) / Time Collected (e.g., baseline, AV3, any) / Proposed lab and analytes to be measured at each lab.
Be specific (e.g., list each polymorphism separately, list both full analyte name and abbreviation).
Plasma citrate / µl
Plasma EDTA / µl
Serum / µl
DNA / µg at ng/µl
Urine / µl
RBC / µl
RNA / µg at ng/µl
Tumor tissue
[NOTE: The WHI CCC will add blind duplicate QC samples as follows: Non-DNA samples = 10% of your sample size; DNA = 5% of your sample size. Investigators will not be un-blinded to the identity of WHI blind duplicate QC samples until results are received at the CCC. It is expected that the laboratory include its own QC samples in addition to the WHI blind duplicates. Please design your study accordingly.]
10. Will Regional Center activities occur for this study?
No à Skip to Q 11
Yes à What activities? (Attach letters of support from participating centers and complete Q10a.)
Recruitment (If recruitment is required, attach consent form.)
Outcomes collection
Other
10a. Describe the type of new participant data to be collected for the study. If questionnaire data are to be collected from the participants, please attach a draft of the questionnaire.
Description of type of data to be collected / Estimated time in minutes to administer / Interviewer (I) orSelf-administered (S)
a.
b.
c.
11. A CCC subcontract is needed if this is a multicenter study or a study requiring biospecimen samples.
Is a CCC subcontract needed?
No
Yes à Contact the CCC () at least 4 weeks prior to grant submission deadline.
12. Do you already have funds for this project?
No à Skip to Q 15
Yes
13. Will any part of this study be funded by industry or a commercial entity?
Yes
No
14. IF FUNDED:
14a. What is the funding source(s):
14b. Does this funding cover all costs of the study, including WHI staff time and CCC costs?
Yes à Skip to Q 16
No à What other non-WHI sources will you use to cover the study costs?
15. IF NOT YET FUNDED:
15a. What is the expected source of funding for this project? (Check as many as apply.) Note: If funding source is a foundation or a private corporation, you may move forward with a funding application only if your own institution agrees in advance to cover the difference between the capped rate (often 10-20%) and the FHCRC rate of 76% for the subcontract budget.
NIH - Institute:
Foundation:
Private corporation:
Existing funds:
Other:
15b. Submission date or planned submission to funding agency:
16. Affiliation of Study Investigator to WHI:
Role: Years of service:
WHI Principal Investigator
WHI Co-Investigator
WHI Committee Member
WHI Consultant
Non-WHI Investigator
WHI staff
17. Additional comments or information for the ASC:
Please sign the application (required) and email to or fax to (206) 667-4142 at the Women’s Health Initiative Clinical Coordinating Center (CCC).
Study Principal Investigator Signatures:
By signing this document, you confirm that you have read and agree to abide by all WHI Ancillary Study policies and the WHI Publications and Presentations policies
Principal Investigator (PI):
Signature Date
By signing below, you confirm that you have read and reviewed this Ancillary Study Application and attached proposal and have advised the PI above on WHI policies and procedures.
Sponsoring WHI Principal Investigator (PI):
Signature Date
R:\Studies\AS Forms\Current\AS Application Form 01/2018.doc