CIBMTR supports investigators in conducting observational studies in hematopoeitic cell transplantation (HCT). Anyone willing to actively participate in the conduct of the study and follow the study development and management process may propose a study using the Study Proposal Outline. We encourage you to use this Word template when submitting your proposal.
Prior to submitting a proposal, we strongly encourage investigators to review:
- CIBMTR Retired Forms: review data fields available in our database; supplementary data collection may be required if sufficient information is not already available.
- Published works: review what has already been studied.
- Studies in progress: review what is in progress.
- Financial Conflict of Interest Policies (MCW and NMDP): ensure research integrity.
This information will assist you in identifying existing research variables and avoid duplication of works already accomplished or those in progress.
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Proposal submission and review process
The proposal is submitted to the CIBMTR Statistical Center at email@example.com by November 15 to guarantee discussion during the upcoming Tandem Working Committee Meeting. A proposal number is assigned, and the proposal is distributed to the MS biostatistician and Scientific Director of the relevant Working Committee.
Statistical Center staff reviews all proposals for scientific merit, feasibility, overlap with other studies and CIBMTR's ability to complete the study in a timely fashion. If duplication is identified, the proponent may be asked to join the Writing Committee of an ongoing study.
In advance of the February BMT Tandem Meetings, the Working Committee MS biostatistician prepares a table of characteristics of patient data based on the population defined in the proposal. This information is used during the presentation at the Working Committee meeting.
Once cleared to move forward, the MS biostatistician contacts the investigator; all investigators are encouraged to personally present their proposals to the full Working Committee each February.
After presentation and discussion, Working Committee members vote for each proposal, assigning a scientific impact score to each.
NOTE: Most proposals will follow this path. However, in special circumstances, a proposal deemed of high merit may be forwarded directly to the Working Committee ("fast tracked") for consideration at another time of the year.
Feedback from Working Committee Meetings at the annual meeting is considered in deciding the relative merits of proposals. Final decisions regarding which studies to pursue are made by the Working Committee Chairs and the CIBMTR Advisory Committee.
Not all proposals can be advanced to the Working Committee for consideration. Those that do come before the Working Committee may be formally accepted and assigned a study number or may be designated as low priority and not accepted at that time. Notification is sent to all investigators within one month of the Tandem Working Committee Meeting.
NOTE: If the study requires biological samples from the NMDP Research Sample Repository, in addition to the review process described here, investigators must include a biosketch or brief curriculum vitae documenting experience in the laboratory methods proposed. The NMDP Institutional Review Board must also review proposed studies before samples can be distributed.
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