Rapid study start/enrollment

Coordinating

• Pre-assign Study Coordinator
• Cross train staff to maximize scheduling flexibility
• Source documents based on GCP & Sponsor CRFs

• Develop and prepare recruitment/media plans and pre-screen prior to first patient screened date
• Submit advertising for approval weeks before first patient screened date

• Use Central IRB of sponsor's choice

• Internal QA/QC audit prior to final archiving
  • Source and CRF
  • Regulatory binders