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 TCT Meetings, proposals must be received by November 15.

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)
• Academic Rank
• Email address for each researcher (up to three)
• Institution name

III. Research Hypothesis

• Scientific question that is the basis for the study

IV. 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.

V. Scientific Impact

• State how the scientific question will change current treatment or practice, or generate data for future studies.

VI. Scientific Justification

• Summarize the rationale for the study, citing relevant previous work
• Convey the importance of the intended study.

VII. 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.
• Depending on the time period considered in the proposed study, Principal Investigators should also review previous versions of the forms.

VIII. 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 one year. 
• 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.

IX. 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.

X. 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).

XI.  Data Source

• List all data sources that will be used in the study. e.g. CIBMTR Research Database, CIBMTR Sample Repository.
• In addition, describe any external data source to which the CIBMTR data will be linked.
• Include the rationale for why the linkage is required, a list of data elements available in both data sources that will be used to link the CIBMTR record with the external record, and the methodology used to link the datasets.
• List of data elements available in all data sources that will be used to link the CIBMTR record with the external record
• Methodology used to link the datasets

XII. References

If the study aims to use NMDP/Be The Match 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

XIII. 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)?

□ Yes. 

□ No.

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

Proposal submission

E-mail your observational study proposal to:  proposals.cibmtr@mcw.edu