Steps for Submitting a Proposal & Using BCSC Data

1. Develop research questions
2. Contact SCC
3. Develop proposal for review by BCSC Steering Committee
4. Refine proposal and submit to SCC for review by BCSC
5. Sign collaborative agreement
6. Plan analyses with the SCC
7. Prepare progress reports
8. Present findings to BCSC at twice-yearly meetings
9. Submit project results
10. Send programs, datasets, and files to SCC for archiving

These steps are also described in the BCSC Data Request Process Guide (PDF).

Step 1: Develop research question(s) that can be answered using BCSC data.

To ensure the project is feasible using BCSC data, investigators are encouraged to work closely with a Statistical Coordinating Center (SCC) and/or BCSC member when developing their project proposal (See Step 2 below). The following are available on this Web site to assist with analytic plans:

1. data dictionary;
2. site-specific questionnaires;
3. tables describing the distributions of some key variables;
4. mammography performance measures such as sensitivity, specificity, and positive predictive value by patient characteristics;
5. BCSC proposal form (RTF); and
6. examples of protocols that use BCSC data.

The Steering Committee or designee(s) will determine whether data analyses are best performed by the SCC or whether deidentified data can be given to an investigator(s) for analysis.

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Step 2: Contact the SCC (scc@ghc.org) or review the list of investigators on the BCSC website.

This step permits investigators to identify an individual who can facilitate completion and review of the BCSC proposal form. Investigators should indicate reason(s) for data request (manuscript, preliminary data for grant proposal, inputs for simulation models, development of statistical methodology).

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Step 3: Develop a proposal for review by the BCSC Steering Committee (send to scc@ghc.org).

Proposals for research projects using the BCSC data should include:

• A description of main hypotheses/research questions;
• inclusion/exclusion criteria for study subjects;
• the study time period;
• a list of key variables;
• a brief description of analytic methods to be used;
• "mockup" tables that correspond to analyses;
• an explanation of how BCSC data will be stored and protected from unauthorized access; and
• a description of the personnel involved, timeline for completion, and relevant experience of the study team.
• If the proposal is from a consulting firm or contractor, the proposal should provide information about the funding source and a letter from the funding organization indicating that the investigator is free to work and publish his/her findings without limitations.

Budgets and detailed staffing plans are not necessary. Proposals should be no longer than 10 pages; most proposals range from 2-5 pages (see proposal form (RTF) and sample approved proposal (PDF)).

Investigators outside the BCSC who are interested in initiating a collaborative research project should contact the SCC at scc@ghc.org and/or the one of the Principal Investigators of one of the BCSC sites.

A response to a proposal request will occur within 2-4 weeks of submission to the SCC.

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Step 4: If necessary, refine proposal.

This step allows investigators to address comments from Steering Committee or designee(s).

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Step 5: After Steering Committee approval, complete and sign a BCSC collaborative research agreement and, if necessary, a Memorandum of Understanding.

Five of the seven BCSC data collection sites are defined as covered entities by the Health Insurance Portability and Accountability Act (HIPAA). The other two sites are either not a covered entity or they obtain data only from subjects who consent for the release of data to BCSC. To meet HIPAA requirements, data released to Group Health by the five covered entities is governed by a data use agreement between each covered entity and Group Health. For more details on required forms, please see the BCSC policy on HIPAA privacy.

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Step 6: Plan analyses with SCC member and develop timeline for data analysis.

This step is for the interaction between the principal investigator and the SCC statistical programmer to discuss and establish the analytical design, table format, and models for data analysis.

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Step 7: Complete a brief progress report twice yearly.

The BCSC tracks data requests to determine how investigators use BCSC data for research. A project update form (PDF) will be sent to the investigator by e-mail in March and September. To assist us with tracking data requests, please complete this form by checking the appropriate boxes and submit it to the SCC at scc@ghc.org within 2 weeks.

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Step 8: Present findings at twice-yearly BCSC meetings.

The BCSC encourages investigators to present their findings at BCSC meetings. These presentations on collaborative projects provide updates to the project as well as give investigators opportunities to discuss and address scientific questions raised by the research.

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Step 9: Submit project results

When the project is completed, investigators should submit results compiled in abstracts for scientific meeting presentation, manuscripts, preliminary data for grant proposals, descriptions of statistical methodology, or other formats to SCC at scc@ghc.org for review by Steering Committee or designee(s) before presenting or submitting for publication. Investigators who wish to submit results to scientific meetings should allow at least 2 weeks before an abstract deadline for the Steering Committee or designee(s) to review an abstract and provide feedback. If necessary, refine analyses to address Steering Committee or designee(s) feedback and submit final analyses to the SCC for final BCSC approval.

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Step 10: Forward analytic programs, datasets and analysis files to the SCC after the project is complete

This step applies only to investigators performing their own data analyses using BCSC data. Data should be sent to scc@ghc.org so that they can be archived. Data must be destroyed after the project is completed.

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