College Of Clinical Research Clinicians

This 5 week, fast-paced course is designed to take a research naive clinician through the entire process of running their own research clinic, or being an Investigator at another clinic.

Week 1: General Responsibilities of Principal Investigators

  • GCP

  • FDA

  • Protocol

  • SOP

  • IRB

  • PI Oversight

  • Source documentation

  • Adverse Event reporting

  • Regulatory

Week 2: Research Staff, Training, and Office Layout

  • PI

  • Sub I

  • Research Coordinators

  • Site Monitors

  • Patient Recruiters

  • Staff workload

  • Contracts and Budgets

  • Clinic set ups

  • Equipment

 

Week 3: SOPs, Regulatory & Source

  • What are SOP

  • What are regulatory documents

  • What are source documents

  • Inclusion/exclusion criteria

 

Week 4: Monitoring Visits and Quality Assurance

  • Site selection

  • Site initiation

  • Interim monitoring

  • Close out

  • Audits

  • Quality control/assurance

Week 5: Contracts and Budgets/Patient Recruitment

  • What is included in a contract

  • How to negotiate a budget

  • Fair market value

  • Pre screening

  • Database mining

  • Retention

Contact us with questions and a staff member will reach out shortly

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