Study Proposal Outline

Use the outline below to draft a formal observational study proposal. CIBMTR accepts observational study proposals throughout the year. Additionally, letters of invitation are distributed by e-mail three times a year. To be included on a Working Committee meeting agenda at the annual Tandem Meetings I Transplantation and Cellular Therapy Meetings of ASTCT & CIBMTR, proposals must be received by October 15, 2021.

Proposals should be submitted to:
Study Proposal Submission

Proposals should include:

I. Study Title

II. Key Words

III. Principal Investigator Information

Name (up to two)
Degree(s)
Email address for each researcher (up to two)
Institution name
Academic rank
Junior investigator status, if applicable
Current ongoing work with CIBMTR, if applicable

IV. Proposed Working Committee

V. Research Question

VI. Research Hypothesis

VII. Specific Objectives/Outcomes to be Investigated

VIII. Scientific Impact

Briefly state how the completion of the aims will impact participant care/outcomes and how it will advance science or clinical care.

IX. Scientific Justification

Provide a background summary of previous related research and their strengths and weaknesses, justification of your research, and why your research is still necessary.

X. Participant Selection Criteria

State inclusion and exclusion criteria.

XI. Data Requirements

After reviewing data available on CIBMTR forms, list patient-, disease- and infusion- variables to be considered in the multivariate analyses.
Data collection forms are available at: http://www.cibmtr.org/DataManagement/DataCollectionForms/Pages/index.aspx

XII. Patient-Reported Outcome (PRO) Requirements

If the study requires PRO data collected by CIBMTR, the proposal should include: 1) A detailed description of the PRO domains, timepoints, and proposed analysis of PROs; 2) A description of the hypothesis specific to PROs.
For additional information on what PRO measures have been collected and timepoints of collection, please reach out to the Late Effects and Quality of Life or Health Services Working Committee leadership: https://www.cibmtr.org/About/WhoWeAre/Committees/wc/LateEffects/Pages/default.aspx

XIII. Sample Requirements (if the study will use biologic samples from the CIBMTR Repository)

If the study requires biologic samples from the CIBMTR Repository, the proposal should also include a detailed description of the proposed testing methodology and sample requirements and a summary of the investigator's previous experience with the proposed assay systems.

XIV. Non-CIBMTR Data Source, if applicable

A description of the external data source to which the CIBMTR data will be linked.
The rationale for why the linkage is required, i.e., neither database contains all the data required to answer the study question.

XV. References

XVI. Conflicts of Interest

Do you have any conflicts of interest pertinent to this proposal concerning:

Employment (such as an independent contractor, consultant, or providing expert testimony)?
Relationships (such as executive and advisory committee positions, medical consultant, speaker's bureau)?
Ownership (such as equity, ownership, or financial interests)?
Transactions (such as honoraria, patents, royalties, and licenses)?
Legal (such as pending or current arbitration or legal proceedings)?

If yes, provide detail on the nature of employment, name of the organization, role, entity, ownership, type of financial transaction or legal proceeding, and whether remuneration is >$5000 annually.

Proposal submission

Submit your observational study proposal here:
Study Proposal Submission

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