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 twice annually, in late summer and late fall. To be included on a Working Committee meeting agenda at the annual BMT Tandem Meetings, proposals must be received by mid-December.
Proposals should be formatted to:
- Standard 8½” X 11” page with 1” margins
- Four pages or less in length
Proposals should include:
I. Study Title
II. PI Information
- Name (up to three)
- Degree(s)
- Email address for each researcher (up to three)
- Institution name
- Title within Institution, new information requested (examples listed below)
- Professor
- Associate Professor
- Assistant Professor
- Instructor (or equivalent)
- Other (please specify position)
III. Specific Aims
- State the primary purpose(s) of the study as concisely and clearly as possible
- Communicate the purpose for which the data will be analyzed
IV. Scientific Justification
- Summarize the rationale for the study, citing relevant previous work
- Convey the importance of the intended study
V. Patient Eligibility Population
- Familiarize yourself with existing CIBMTR data collection forms so that you know what variables are available for the patient population(s) you wish to study
- Include study requirements for age, disease, disease stage, year of transplant, graft and donor types, prior treatments, specific transplant regimens, or any other restrictions relevant to the study
VI. Data Requirements
- Identify which data collection forms will be needed for your study. Contact us at contactus@cibmtr.org if you need help with this process
- Specify whether your study will require collection of supplemental data and how this will be accomplished. Note that collection of additional data will extend the time for completion of your study by a substantial amount
- If the study involves combining CIBMTR data with data from another group, specify the selection criteria for patients from the other database
- Include a list of variables from the existing CIBMTR data collection forms that need to be analyzed, and desired outcome variables
VII. Sample Requirements (if study will use biologic samples from the NMDP Research Sample Repository)
- Define sample type – DNA, serum, cell lines or viable peripheral blood mononuclear cells
- Quantify amount of DNA, serum volume or cell count – the number of specimens requested should be justified based on sample size consideration
VIII. Study Design (Scientific Plan)
- Describe, in non-technical terms, how specific aims would be addressed using information from the CIBMTR database
- Include the specific statistical methodology planned, with discussion of limitations, if relevant (CIBMTR biostatisticians are available to provide assistance with this process, including relevant power calculations)
IX. References
If study is to use NMDP samples, the proposal should also include:
- A detailed description of the proposed testing methodology
- A summary of the investigator’s previous experience with the proposed assay systems
- A biosketch or brief curriculum vitae documenting experience in the laboratory methods proposed
Proposal submission
E-mail your observational study proposal to: contactus@cibmtr.org.