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When:
January 25, 2018 @ 3:30 pm – 6:00 pm
2018-01-25T15:30:00-08:00
2018-01-25T18:00:00-08:00
Where:
LK130
Li Ka Shing Building
291 Campus Drive, Palo Alto, CA 94305
USA
Li Ka Shing Building
291 Campus Drive, Palo Alto, CA 94305
USA
Contact:
Kiera Larsen
Presenter: Ken Mahaffey, MD
HRP273 Essentials of Clinical Research at Stanford, Winter Quarter 2018
We are excited to announce the second annual “Essentials of Clinical Research at Stanford” Winter Quarter! This course, broken into 4 modules, provides a step-by-step model for the design and conduct of clinical research at Stanford. Upon course completion, attendees will have an introduction on how to:
- design and analyze clinical studies and prepare protocols,
- comply with Good Clinical Practice guidelines for study conduct, data management, and relevant regulations,
- understand principles and practices underlying ethical and reproducible research, and
- deal with special issues that arise in cancer, pediatric, mental health, surgical, cardiovascular and community health research.
This course is a collaborative effort with Spectrum and the Health Research and Policy department. Module 2 classes of the Winter Quarter (as well as Modules 3 and 4) are listed below for your reference. Please join us by clicking here to register and please let us know if you have any questions!
| Module 2: Conduct of Research | |||||
| Day | Date | Room # | Topic | Details | Speaker |
| Thurs | 18-Jan | LK130 | Running a Clinical Trial | Study Set-up, regulatory review, budget and contract, study team, GCP, delegation of authority, informed consent, essential documents and documentation | Peg Tsao, RN, Kiera Larsen, RN & Maya Berdichesky, DMD |
| Thurs | 25-Jan | LK130 | Trial Closeout | Evidence based operations, end of study planning, statistical analyses, trial committees, DSMB, CT.gov reporting, data sharing/open source | Ken Mahaffey, MD |
| Module 3: Ethics and Reproducibility | |||||
| Day | Date | Room # | Topic | Details | Speaker |
| Thurs | 1-Feb | LK130 | Ethics and Clinical Research | Responsible conduct of research and misconduct, rules of science, informed consent | Holly Tabor, PhD |
| Thurs | 8-Feb | LK130 | Research Reproducibility | Statistical analysis tool and data science | Steven Goodman, MD and Tom Hardwicke, PhD |
| Module 4: Specialty Topics | |||||
| Day | Date | Room # | Topic | Details | Speaker |
| Thurs | 15-Feb | LK130 | Research Issues in Surgery | Arden Morris, MD | |
| Thurs | 22-Feb | LK130 | Research Issues in Cancer | Clinical trial and regulatory processes for anticancer drug development, early phase trial design, evolving designs for targeted agents and regulatory framework for drug development | Shivaani Kummar, MD, Nam Bui, MD and Nora Ku |
| Thurs | 1-Mar | LK120 | TBD: Pediatrics or Cardiovascular Medicine | TBD | |
| Thurs | 8-Mar | LK120 | Research Issues in Community Engagement | Rhonda McClinton-Brown and Lisa Goldman Rosas | |
| Thurs | 15-Mar | G1002 | TBD: Pediatrics or Cardiovascular Medicine | TBD | |
| Thurs | 22-Mar | G1002 | Research Issues in Psychiatry | Ruth O’Hara, PhD | |