Training Program Title

Freely Available Regulatory Science Boot Camp Lectures

CTSA Hub Administered

yes

Contact Information

Amelia Spinrad, MS Regulatory Science Student | spinrad@usc.edu

Training Program Description

The D.K. Kim International Center for Regulatory Science, in conjunction with the Southern California Clinical and Translational Science Institute and the Greater Los Angeles Clinical and Translational Sciences Awards Consortium, hosts boot camps on current regulatory science topics regarding clinical trials. Boot camps are designed to address the needs of the clinical research team members but anyone interested in the topics is welcome to attend in-person.

All boot camps are recorded and are freely available for viewing after the event here.

Boot camp topics are listed below and linked to articles written on each of these boot camps:

Competency Keywords

Biomedical research, Clinical trial, Vulnerable population, Participant safety, Biologic, Drug, Good manufacturing practice, FDA (Food and Drug Administration), IND (Investigational New Drug or Device), Sponsor, Adverse event, GCP (Good Clinical Practice), Regulatory guidelines, Essential documents, Regulatory binder, Reporting requirements, Safety reporting, Source documents, Inspections, Monitoring, Quality assurance, Protocol compliance, Clinicaltrials.gov, Data quality, Quality assurance

Other Keywords

clinical trial hurdles, clinical trial startup, monitoring and auditing, special populations, emerging technologies and treatments, regulatory aspects of clinical trial design, pharmacovigilance and safety reporting

Digital Commons Disciplines

Adult and Continuing Education | Interprofessional Education | Other Pharmacy and Pharmaceutical Sciences

Public

yes

Cost to Access

no

Competency Domains

Scientific Concepts and Research Design; Ethical and Participant Safety Considerations; Medicines Development and Regulation; Clinical Trials Operations; Study and Site Management; Data Management and Informatics

Delivery Method

Other

Other Delivery Method

Boot camps are offered in-person and recorded for viewing after the event

Target Learners

Principal Investigators; Clinical Research Professionals (other than PI); MDs including residents, house officers, fellows, hospitalists; Undergraduate, graduate or professional degree students; Post-doctoral scholars; Community Partners

Learning Level

Skilled

Onboarding

no

Frequency

Semi-Annually

Time Needed

6 hours per boot camp

Associated Assessment

no

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