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Required Application Materials

During this course, participants will work with faculty to develop a complete protocol and draft informed consent. All application materials will be submitted through the course website. Applicants will submit a 2-page synopsis of their proposed clinical trial using the course template (completed trials or trials in progress will not be accepted). Project proposals are expected to be preliminary and the investigators do not need to have received funding or IRB approval for the purposes of the course. The project must, however, fit the following criteria:

• Only clinical trials will be considered for this course. Clinical trials, by definition, study an intervention. This intervention may take many forms, including but not limited to drugs, biologics, behavioral interventions, devices, or surgery.
• Observational studies, biomarker studies, and clinical measure development projects will not be reviewed.
• The proposed clinical trials should not be comparative efficacy or phase III studies, but should address questions relevant to early or middle development of the intervention (e.g., dosage, activity, safety).
• The proposed trials should be appropriate in size and scope for the investigator’s stage of career development and the expected source of funding. Large multicenter trials would not be appropriate for most investigators.

Additionally applicants must submit:

1. An NIH style biosketch
2. A description of their research plans for the next 2 years and their career goals (1 page maximum)
3. An explanation of how the course will help them to implement their proposed clinical trial (1 page maximum)
4. A brief, signed statement of commitment to participate in the long-term evaluation of the course by maintaining contact with the organizers and responding to questionnaires
5. A letter from the trainee’s mentor or unit director/chair is required. The letter must address:
   • The mentor's relationship to the trainee
   • The quality of the trainee's current and prior work
   • The mentor's commitment and plans to facilitate the proposed project
   • The mentor's prior experience in guiding students in clinical research
   • A statement of commitment by the mentor to participate in long-term evaluation of the course by reporting on the trainee's progress on the project and career development
   • The resources that will be allocated to support the conduct of the trainee's proposed clinical trial

Application materials must be submitted on the website as a single PDF file. If you would prefer to submit a hard copy, please e-mail the course via the "Contact Us" tab above. The protocol synopsis and the additional elements of the application are required. Applications will be reviewed by the program committee and investigators will be informed in May 2010.

Selection of Participants

The Program Committee will serve as the selection committee. The criteria for trainee selection are:

• A research question that is important, feasible, and will benefit from development in the course
• A proposed study that is likely to be completed, based on the trainee's track record, environment, mentoring, and potential support
• A strong commitment to clinical research and clinical trials, as evidenced by current and prior work and training
• An intention to pursue a career in clinical research and clinical trials

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