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July 21, 2008: Day 1: Introduction to Clinical & Translational Research |
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| 2:00-2:30 |
Keith Muller, PhD, Betsy Shenkman, PhD |
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Overview of course purpose & content Course expectations
Definitions: clinical and translational research
“research team,” other roles including sponsor |
| 2:30 - 3:15 |
Mark Brantly, MD |
“Why I do clinical/translational research” |
| 3:15 - 4:00 |
Panel Presentation |
“How I succeeded in getting my grant funded” |
| 4:00 - 5:00 |
Small Group Break-Out Sessions. Group assignments will be distributed. |
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July 22, 2008: Day 2: Formulating a Testable Research Hypothesis |
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| 2:00-3:00 |
Panel Presentation |
“Formulating the Question” |
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Keith Muller, PhD, Jon Shuster, PhD, Bruce Vogel, PhD |
| 3:00 - 4:00 |
Panel Presentation |
“Formatting the Question – Hypotheses and
Specific Aims” |
| 4:00 |
Small Group Activity |
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July 23, 2008: Day 3: Overview of Study Designs |
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| 2:00 – 3:50pm |
Overview of Clinical Trial Designs - |
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Mini Devidas, PhD |
Phase 1 through 4 Clinical Trials |
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Bobby Thompson |
CCTR Phase I Unit at UF |
| 4:00 – 5:00pm |
Bruce Vogel, PhD |
- Overview of Observational Study Designs |
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No Small Group meeting today |
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July 24, 2008, Day 4: Measurement in research |
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| 2:00-2:50 |
tba |
Patient reported outcomes and surveys |
| 3:00-3:50 |
tba |
Which data? How should it be measured? Avoiding pitfalls. |
| 4:00 |
Small Group Activity |
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July 25, 2008. Day 5: Choosing An Analysis Which Maximizes the Study Impact and Efficiency |
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| 2:00 – 3:50 pm |
Jon Shuster |
- Issues to Consider in Developing the Analytic Plan |
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Aligning Study Aims, Effective Study Design, and Analysis (Terminology: Population, sample,
Type I and Type II error (power), Point and interval estimates motivated.
P-values illustrated by Re-randomization test in real trial (non-technical).
Bias vs. sampling error. Impact of Multiple testing both over time and via multiple endpoints.
Stratification, matching, crossover, covariates). |
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| 4:00 |
Small Group Activity |
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July 28, 2008, Day 6: Practical Issues in Study Design |
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| 2:00-3:30 |
Betsy Shenkman, Teresa D’Angelo, Bob Kolb |
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Study Site Selection and Subject Recruitment/Retention
Participant retention
Ethical and patient considerations here |
| 3:30-5:00 |
Designing and implementing the database
Doug Theriaque and Chris Barnes |
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No Small Group meeting today |
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July 29, 2008 Day 7: Practical Issues in Study Management |
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| 2:00-3:50 |
Doug Theriaque,
Chris Barnes |
– Considerations and Resources for Data Management |
| 4:00 |
Small Group Meetings |
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July 30, 2008, Day 8: Regulatory and Privacy Issues |
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| 2:00-3:50 |
Michael Mahoney |
IRB Overview |
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Tba |
VA Regulations for investigators and participants |
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Susan Blair |
Privacy (HIPAA) |
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Yvonne Brinson |
Compliance |
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Reggie Frye |
Tissues, Fluids, Genetic material |
| 4:00-5:00 |
Small Group Meetings |
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Homework: HIPAA certification, HIPAA for researchers |
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Websites will be distributed to obtain appropriate certification.
Students will be required to provide copies of certificates on July 21, 2008 |
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July 31, 2008, Day 9: Developing a GCRC submission |
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| 2:00-2:50 |
Larry Edwards |
Accessing the GCRC |
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Theresa D’Angelo |
How the GCRC works |
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| 3:00–3:50 |
Peter Stacpoole and panel |
CTSI Update and Core Programs |
| 4:00-5:00 |
Small Group Meetings |
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August 1, 2008, Day 10: Small Group Presentations |
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| 2:00-5:00 |
Presentations and Q&A for all Small Groups |
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| Student Evaluation: |
Certificates will be awarded for:
- Minimum 70% attendance and participation
- Completion of HIPAA training (online) by Day 9
- Completion of Evaluations
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Students will be graded on the following: (for those registered for graduate credit)
- Attendance 25%
- Attendance and participation in small group activities – 50%
- Class Presentation – 25% |
