MPTX 630: Directed Field Research Project

“Book-learning” is important but equally important is the application of learned principles to the management of real-life regulatory, quality and clinical problems. For students without previous background in the field, an internship period in industry is offered during which trainees work alongside other professionals in industry and government. These internships are arranged with the help of the School of Pharmacy, and in consideration of the future career interests of the individual trainee. Each year, a roster of sites interested in trainees will be published, and interviews will be arranged so that an appropriate match can be constructed for the trainee. If trainees have already ideas about sites in which they wish to spend this period they should identify these interests early. In addition, individuals already in industry may be interested in conducting a research project in their home institution. We encourage such activities, but the arrangements must be approved before formally registering in the course.

Instructors: Frances J Richmond, PhD School of Pharmacy, USC
Richard Proffitt, PhD, adjunct faculty, School of Pharmacy

Course weight: 6 Units
Placement: Varies by student; full-time in practicum settings
Prerequisites: Completion of at least 20 credits toward the MS (Regulatory Science) degree or permission of instructor

Introduction and Purposes:

A unique feature of the MS program in Regulatory Science is the opportunity to work as an intern at a practicum site. To increase the value of this experience, students are required to complete a research paper on a subject that is chosen in consultation with the course supervisors and the mentor at the practicum site.

The research project will be related to the type of work in which the student will be engaged on a day-to-day basis. All projects will be chosen to ensure that students conduct certain key activities:

The research project should have a component that requires review of scientific or regulatory literature in research journals. This information should be reflected in the written project report that should have an up-to-date reference list.

The research project should include a component that requires interpretation of governmental guidelines
The work should involve a synthesis of practical experience with fundamental regulatory principles and theory

It is recognized that some students will carry out work in areas that require a considerable level of non-disclosure and discretion. In these instances, discussions will be held at the beginning of the project to agree upon ways in which students can protect proprietary information. If this is not possible, the topic should be changed or the practicum site reconsidered. The research should be written up in a paper that is no more than 30 double-spaced pages in length. The paper will be marked by the faculty supervisor and one other member of the mentoring team.

Evaluation:

Students will be evaluated individually in two ways:

Written project: 60%
Performance in practicum site: 40%
The final grade will be assessed as a pass or fail.

Written project:

The research paper will be evaluated on the basis of the following criteria:
- Clear introduction of the problem to be solved
- Review of current guidelines and identification of regulatory requirements
- Identification of other issues that affect testing plan
- Specification of testing or research protocol
- Identification of potential problems or biases that cannot be eliminated
- Timeline and budget for the research or testing plan
- Performance at Practicum Site:

Practicum performance will be evaluated by the industry mentor and at least two of the course supervisors. One course supervisor will serve as the primary contact and coordinator for each student and will visit the site at least twice during the course of the practicum experience. Near the midpoint of the practicum, the course supervisor will consult with the student to evaluate the effectiveness of the learning experience from the student’s point of view, and to identify any problems that have arisen. Together with the on-site mentor, the performance of the student will be evaluated on a performance assessment sheet (attached), and the performance will be graded using a letter grade. Places for improvement will be identified and discussed with the student. At the end of the experience, the student will again be graded using the same performance assessment criteria. He or she will meet with the supervisor for an exit interview and discussion of performance.