Research Practicum Program

Goals
The goals of the practicum research program are to:

1. Provide CR Scholars practical, hands on experience in clinical research through active participation in ongoing clinical research projects with at least two mentors from different disciplines
2. Help CR Scholars develop and implement their own clinical research project from start to finish within a multidisciplinary framework.
3. Develop CR Scholars’ ability to disseminate results through abstracts, manuscripts, posters and verbal presentations
4. Teach grant writing skills by having the CR Scholars write their own grant for submission, edit/critique other CR Scholars’ grants and revise and resubmit their grant proposals based on critiques and comments from a multidisciplinary panel
5. Facilitate successful development of the CR Scholar from trainee to independent clinical investigator through ongoing interactions with at least two mentors from different disciplines
6. Develop successful multidisciplinary clinical research teams

In order to train clinical investigators it is essential to provide formal didactic educational programs, and to integrate didactic education with practical hands on experience in clinical research.

Skills
Essential skills fostered in this practicum research experience include:

• Developing a research question and generating a hypothesis
• Identifying an appropriate and feasible study design
• Obtaining IRB approval
• Ensuring the protection and safety of research subjects through informed consent and monitoring
• Understanding and dealing with ethical issues in order to maximize responsible conduct of research
• Developing data collection tools
• Establishing and standardizing definitions
• Learning and understanding how to use the best methods for data collection (chart review, paper and web based surveys, interviews, focus groups, etc.)
• Development and implementation of interventions and clinical trials
• Data management (design of data entry screens, data entry, use of scanning technology, use of hand held devices to synch data into datasets, cleaning datasets, merging data sets, data security)
• Data analysis (univariate and multivariate analysis, survival analysis, graphic displays)
• Biostatistics and Epidemiology (power and sample size calculations, cluster analysis, ROC curves, how to access and collaborate with biostatisticians/ epidemiologists, etc.)

Grant Writing
Grant writing skills are a vital part of the practicum research experience and can be learned through a structured process which flows from didactic coursework into practical experience.

Successfully writing and obtaining grants requires knowledge of:

• Funding streams and the different agencies that support clinical research
• Contracts, cooperative agreements, and grants
• How to develop a competitive grant proposal
• Details and components of each of the sections within a grant application
• How to develop a budget
• Timelines
• Supporting documents (letters of support, appendices, tables, reference materials)
• What reviewers and study sections are looking for

CR Scholars will obtain these skills through coursework, reading examples of successful grants, writing and submitting their own grant application through an interactive process with editing and feedback provided by their peers and two mentors, as well as by editing and reviewing other CR Scholar’s grants during the research practicum experience.

A resource library of grants (hard copy and electronic) will be established and catalogued by research area, investigators with their contact information, departments/discipline, and funding agency to facilitate searches and queries. This will help CR Scholars identify additional mentors and future collaborators across multiple disciplines.

Additional essential skills include development of human resources, management, and administration and team leadership skills. The practicum research experience provides the atmosphere, guidance, professional resources and encouragement for CR Scholars to:

- Build, lead and work within teams
- Deal with interpersonal and workplace conflicts
- Give and get objective performance appraisals
- Provide ongoing timely feedback to improve productivity
- Find / be successful mentors
- Maximize time and resource utilization
- Enhance networking and collaboration
- Manage budgets

CR Scholars will need to learn to communicate effectively across multiple disciplines which have different “languages”, and learn to break down hierarchical organizational cultures which traditionally may have placed certain disciplines in dominant or leadership roles and other disciplines in more subordinate roles. A classic historical example would be physicians and nurses working in separate systems on the same clinical problem or patient population instead of working together as one collaborative or cohesive team.

A practical skills seminar series will address these issues, which will include multidisciplinary faculty, speakers from the business school, management and leadership experts, communication experts, organizational culture specialists, psychologists and others from diverse disciplines.

The Practicum Research Experience
The practicum research experience will begin immediately upon enrollment into the CR Scholars program and will last throughout their tenure. It will accommodate CR Scholars from diverse backgrounds. The nature of their background, training and research experience and their intended tenure as a CR Scholar will guide the development of their individual practicum experience.

Setting Short and Long Term Goals
Realistic short and long term goals will be set with each CR Scholar based on their experience to identify timelines for their research projects, abstract submissions, manuscript preparation, and ultimately grant writing. In general, CR Scholars should have at least one short term project which can be completed within a two year time frame from start to finish, including data collection, analysis and dissemination of results.

For CR Scholars anticipating 3-5 years of training, their timeline will be expanded to include development of longer and larger projects in addition to the project begun in their first two years. The longer term project(s) will be expected to build upon their first project, be more complex in scope and require a longer timeline that matches the period of their proposed training.

Submission of Grant Proposal
CR Scholars will also be expected to write and submit a grant proposal. It is anticipated that this initial grant would be a K series career development type award which would begin after they finish their MCRCDP program, but for some CR Scholars it could be a RO1. It is anticipated that these grants would be submitted to a federal agency for review to help continue the CR Scholars' development. Prior to submission, these grant applications will be reviewed and edited by members of the MAC, research team leaders or enabling technology team leaders as well as the CR Scholar’s mentors to promote teamwork and multidisciplinary approaches.

Independence
The ultimate goal of the MCRCDP is to facilitate the transition of CR Scholars to independent investigators who are capable of working in and leading multidisciplinary clinical research teams. One of the measures of this independence is the CR Scholar’s ability to obtain sustained funding, and in the longer-term, to become mentors and train the next generation of clinical investigators in multidisciplinary clinical research.

Writing, Speaking, Publishing
The success of our MCRCDP will be measured objectively by tracking the abstracts, manuscripts, presentations and grant proposals submitted by the CR Scholars as well as their success in publishing their work in peer reviewed journals, presenting at national meetings, obtaining funding, obtaining faculty, industry or governmental positions with substantial time committed to research and mentoring additional trainees in the future.