Site Training

Site Training

PHACT provides hands on training for individuals who are employed by, or wish to be employed by investigative sites in areas where we conduct trials. Training comprehensively addresses FDA and ICH/GCP guidelines for conducting clinical trials by covering a trial from the site perspective in sequence, from pre-study visit to study closeout. It is designed for new study coordinators (CRCs), research nurses or clinical trial investigators and for any site personnel without formal GCP training. Items covered include the following, but are not limited to:

 

Preparing for a Study Initiation Visit

  • Recruiting Subjects (nuances in patient education will be addressed)
  • Gathering and Recording Data
  • Informed Consent Process
  • Regulatory Binder
  • Source Documents
  • Case Report Form
  • Adverse Events
  • Monitoring Visits
  • Investigative Drug Management and Accountability
  • GCP Review

Starting a Study

  • Protocol Review and Training
  • Review of Target Patient Population
  • Regulatory Document Collection
  • Contract Negotiation
  • EDC Training
  • Corresponding with the Institutional Review Board (IRB) or Ethic’s Committee
  • GCP/ICH Training for Clinical Site Staff
  • Study File set up

Closing a Study

  • Final Regulatory Document Collection
  • Regulatory Document Binder
  • Document Storage Requirements
  • Database Clarifications and Closure

Other

  • Study Budget Management
  • Vendor Management and logistics
  • Sample Control
  • Drug Import and Storage
  • Study Budget Management
  • Dealing with Ethical Issues
  • Understanding ICH Guidelines
  • Preparing for an FDA Audit
  • Improving Productivity
  • Creation and Use of Clinical Trial Financial Reports
  • Financial Analysis of a Protocol
  • Drafting the Subject Budget
  • Tracking Study Activity