*Elective is inactive until further notice*
Supervising Attending:
- Karen Marder
Description:
During the clinical trials electives, residents will participate in different phases of active clinical trials in the CUIMC neurology department.
Objectives:
- To gain exposure to different components of clinical trials including clinical trial design, approval, recruitment, visits, and completion
Requirements:
- Complete TC0087 Human Subjects Protection Training (includes Minors and FDA where applicable)
- Learn up to 2 of the following fundamentals of conducting clinical trials. The two will be selected with guidance of PIs and which parts of a clinical trial the resident is being assigned to observe that week
- Components of the pre-site selection form
- Site Selection Visits, Site Initiation Visits, Monitoring Visits, and Study Close-out Visits.
- Components of a clinical trial
- Obtaining consent for a clinical trial
- Basic components of the rascal submission
- Reviewing a study budget
- Process for reporting an adverse event
- What study coordinators do when drug supply arrives
- How a study coordinator does to randomize a subject
- Observe a participant screening, baseline, procedure, followup, and/or study termination visits in randomized trials and open label studies.
- Attend weekly study recruitment/signatures meeting
- Review current literature relevant to trial resident is assigned to observe
Schedule:
- The first day will be set aside to complete the following:
- RASCAL Training module
- Reviewing IRB protocol for studies you will be observing
- Read papers assigned to you based on the studies you will be seeing
- Meet with Ismael Castaneda for lecture on the role of an investigator, review of regulatory binder, and basics of consent
- The schedule for the rest of the week and requirements will be provided by the Chief Resident, with guidance from Dr. Marder
Location:
PH10
Contacts:
- Dr. Marder: General contact
- Ismael Castaneda (PH10): Dementia studies
- Kaho Onomichi: Neuroimmunology studies
- Ameneh Onativia: Pediatric neurology studies
- Irving institute Outpatient PH10 contact: 212- 305-8355
Updated 7/21/25