1. Bernedine Lund/Sue Mann 5/6/09

3.  Baseline—All participants ◦ Serum ◦ Plasma (citrate & EDTA) ◦ Buffy coat ◦ Red blood cells ◦ Urine (BMD subsample—3 sites only)  Follow-up: Blood ◦ CT: 100% year 1, 6% years 3,6,9 (no DNA) ◦ OS: 100% year 3  Follow-up: Urine ◦BMD subsample: 100% years 1,3,6,9 (no blood)  Details: www.whiscience.org/about/biospecimen.php

4. Blood collection and storage data  Blood sample number  Status of Participant o Hours since last ate o Vigorous activity in previous 8 hours o Aspirin or NSAID in previous 48 hours  Blood processing data o Time drawn o Time centrifuged o Time aliquoted o Time frozen  Number of freeze/thaw cycles

5.  CBC done by local labs on 100% of participants ◦ CT/OS WBC, hematocrit, and platelet count at baseline [for eligibility assessment, NOT core analytes] ◦ OS WBC at Year 3  Core analytes ◦ Measured on 6% CT cohort, ~1% sample of OS ◦ Analytes include micronutrients, lipid profile, clotting factors, insulin, glucose  Details: www.whiscience.org/about/biospecimen.php

6.  Core studies  Ancillary studies  BAA studies  Collaborative studies

7.  All data derived from WHI biospecimens must be provided to the CCC.  All WHI investigators will have rights to use these data in accordance with WHI publications and ancillary study policies.

8.  Data derived from WHI (core) funds ◦ Policy for access is the same as all other WHI data ◦ Only CBC currently available on the website  Data derived from ancillary or BAA studies ◦ Access to data protected until first publication or end of the funding period ◦ WHI actively encourages collaboration with the AS/BAA PI

9.  Web Sites ◦ WHI Science: Funded studies ◦ WHI Study Operations: Funded and approved (not yet funded) studies  Key WHI Science Reports 1.Funded Studies 2.Studies Using Blood Specimen by Outcome 3.Assays by Outcome 4.Assays by Study

11. 2. Biospecimen Use by Outcome for Funded Studies http://www.whiscience.org/ancillary/biospecimen_by_oc_funded.pdf

14. Blood assay information collected  Assay name  Units  Type of specimen  Lab name  Assay method (if available)  Version number of assay ◦ A change in any of the items above leads to a change in the version number.

15.  Nothing is available on everyone  Each study designed for specific goal ◦ Cases and controls are not representative of the WHI population  Labs and/or methods may vary from one study to another  Pulling biomarker data from multiple unrelated studies not recommended

16. Investigator submits proposal to ASC assistant Study needs specimens? yesLab Committee Review no Ancillary Study Review if needed CCC develops subcontract Executive Committee ReviewProject Office Review Study needs ppt consent? yesOSMB Review Investigator submits proposal to funding agency

17. Data Ops and Stat Unit Representatives Meet Investigator Completes a Biospecimen & Participants Questionnaire CCC hosts kick off conference call Stat Unit selects participants Data Ops Unit finalizes the biospecimen details and asks the investigator to ‘sign off’ on the “facts“ Database Unit creates the sample pulls and coordinates the processing and shipping Upon Approval and Funding:

18.  Sue Mann  Data Operations Manager  Women’s Health Initiative  206-667-2869  smann@whi.org smann@whi.org