Working Committee 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 per 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 13, 2023.
Proposals should include:
I. Study Title
II. Key Words
III. Principal Investigator Information
- Name (as many as two)
- Email address for each researcher (as many as 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, a justification of your research, and an explanation of 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 on the CIBMTR website.
- Additional data collection is extremely difficult and will make your proposal less feasible.
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 regarding which PRO measures have been collected and timepoints of collection, please reach out to the PRO leadership team.
XIII. Machine Learning
- Please indicate if the study requires methodology related to machine-learning and clinical procedures.
- More information about our Bioinformatics Program can be found on the CIBMTR website.
XIV. 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.
- PIs should be encouraged to review inventory details, sample types collected and reach out to firstname.lastname@example.org with any questions.
- More information can be found on the Resources page on the CIBMTR website.
XV. Non-CIBMTR Data Source, if applicable
- A description of the external data source to which 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.
XVII. 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 more than $5,000 annually.
BEFORE FINAL SUBMISSION, please review the PI checklist to ensure that you have completed all necessary steps. This will increase the liklihood of submitting a feasible and successful proposal.