Prospective Trials
Retrospective Trials
Literature Reviews
Case Reports
Prospective Trials
For residents involved in prospective trials, your research requirement will be fulfilled once you have demonstrated significant participation in the project.
Project’s early phase: significant participation involves either coming up with the initial idea or collaborating in shaping the trial, writing or helping to write the proposal and data collection forms, and assisting with the IRB process.
Data collection phase: significant participation involves recruiting patients, obtaining informed consent, assisting with ongoing IRB reviews or check-ins, organizing data as it is obtained, and any other issues that arise during the clinical trial.
Data processing phase: significant participation involves active data analysis, collaboration with other trial team members in shaping the presentation of data, writing portions of the manuscript - such as methods, results, or discussion sections, creating figures and tables to be used in the manuscript, and assisting with the publication process.
Each resident’s significant participation requirement will need to be verified by the Primary Investigator or the faculty mentor of the trial.
Retrospective Trials
For residents involved in retrospective trials, your research requirement will be fulfilled once you have demonstrated significant participation in the project.
Project Inception: significant participation involves either coming up with the initial idea or collaborating in shaping the trial, writing or helping to write the proposal and data collection forms, and assisting with the IRB process.
Data collection and processing: significant participation involves data collection if this is performed on >1,000 patients by any single individual researcher. For studies requiring smaller sample sizes, or with multiple researchers requiring analysis of <1000 patients each, significant participation requirement will also involve data analysis, writing portions of the manuscript, and assisting in the publication process.
Literature Reviews
For residents involved in literature reviews, significant participation must involve completion of the project and participation in every phase of the project, including coming up and shaping the original idea, performing a literature review, and writing portions of the manuscript. The completed project must be of publishable quality as determined by the Program Director.
Exceptions may be made on a case by case basis by the Program Director if a project has undergone significant transformation since its inception and the Program Director feels that the participating residents have grown in their medical knowledge and appreciation of clinical research as a result of participating in the project.
Most literature reviews cannot accommodate more than two residents participating. Exceptions may be made on a case by case basis specifically for systematic reviews involving large sample sizes of articles, or meta-analyses requiring extensive data collection and processing, especially if the project team undergoes delays during data collection through no fault of their own. This will also have to be verified by the Program Director.
Case Reports
A case report must be completed in order to satisfy the research requirement. In this case, it must be of publishable quality, meaning formatted with a specific Journal in mind, and include all consents as needed for publication. Most case reports cannot accommodate more than one resident. Exceptions may be made for case series involving data processing and data collection, or case reports that encompass a systematic review, or for any other reason as deemed appropriate by the Program Director on a case by case basis.
For a more detailed discussion on scholarship, check out this paper