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 14, 2022.
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
XII. Patient-Reported Outcome (PRO) Requirements
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