Thesis or Substantive Research Project

Individuals pursuing the Master of Science in Clinical Research are required to complete a formal thesis or substantive research project. The project will count for up to 3 credits and must satisfy the following requirements:

  1. be primarily independent work by the trainee,
  2. receive preliminary approval from both the trainee's advisor and the ICRE Leadership, and
  3. form the basis for a comprehensive review of competence by a formal review committee.

There are three standard mechanisms that are considered appropriate for the substantive research project (see below), subject to ICRE approval. To obtain approval, the trainee must submit a one-page prospectus in the fall term of his/her second year in the program that provides a brief description of the intended project. The prospectus must be approved by the trainee's advisor and, in turn, the ICRE Leadership before the trainee may proceed. It also should identify 3-4 faculty members who will serve on the trainee's review committee. The mechanisms for the substantive project include:

  • A standard thesis option: trainees may elect to complete a master's thesis in their field of specialty. A thesis produced under this option must conform to all applicable university policies regarding theses (visit www.pitt.edu/~graduate/etd for details on submitting theses electronically) and be defended before the review committee (described below)
  • R01, K-award, or equivalent grant application: Eligible students may submit a completed R01 or equivalent research proposal (for which they are the principal investigator) as evidence of their ability to plan and conduct independent research. To serve as the substantive project for the Master of Science in Clinical Research, the proposal must be reviewed and approved by the appropriate scientific review committee in the trainee's department. It also must be reviewed and approved by the review committee (described below). At least one member of the committee must be independent (i.e., not on the grant). Note that career development awards funded through the K12 mechanism may not be used as the final project.
  • Peer review publications: The compilation of two completed first author papers related to the trainee's research may be used as evidence of independent work at the discretion of the individual specialty track. The papers must be original research papers and be written in a competitive manner. Each paper must be reviewed by at least 2 committee members who are not coauthors. At least one member of the committee must be independent (i.e., not a coauthor on either paper), and no committee member (except the trainee's mentor) can be a coauthor on both papers. The papers also must be critiqued and approved by the review committee (described below).

Each of the options listed above must be reviewed and defended before a review committee, and members of the committee must be identified on the review committee form. Trainees submit the review committee form and the one-page prospectus form for approval at the beginning of their second year. At a minimum, the review committee must include the trainee's research mentor, an ICRE faculty member, and an ad hoc member who is familiar with the trainee's project. At least one member of the committee should be from the trainee's department. In addition, at least one member of the committee must be independent of the project. The ICRE committee member will determine if an additional reviewer with statistical or other methodological expertise is necessary.

The trainee's presentation to the review committee should be scheduled at least two months prior to graduation to allow enough time for revisions and subsequent reviews. Once approval is granted by the review committee and formal documentation is submitted to the ICRE, the trainee will receive a passing grade and will be permitted to proceed with the graduation ceremonies.