Clinical Research Study Road Map

Visit the study assessment, study start-up, study conduct, and study closure pages below to learn more about each step and access related policies, guidelines, forms and templates, and training. You may also wish to contact the Office of Clinical Trials staff or visit the Office of Clinical Trials homepage for additional information.

View an illustration of the steps listed below in the UMMC clinical research study process.

• Researcher Road Map - PDF

Study assessment

• Confidentiality Agreement
• Review Protocol
• Site Qualification
• Accrual Feasibility
• Recruitment Plan
• Logistics
• Design of ICF
• Financial Disclosure/COI Review

Study start-up

• Study activation

  • ACT Process
  • Budget
  • IRB/Ancillary Committee Review
  • Contract Negotiation
  • ClinicalTrials.gov Registration

• Study set-up

  • Study Operations Planning
  • Data Collection Plan
  • Regulatory Files
  • Staff Training and Delegation
  • Lab
  • CRTU
  • Research Billing
  • Investigational Drug Service
  • Velos
  • Site Initiation

Study conduct

• Participant recruitment

  • Advertising
  • Recruitment
  • Screening
  • Consenting

• Participant management

  • Velos
  • Biospecimen Management
  • Participant Follow-Up
  • Remuneration/Reimbursement
  • Research Billing
  • Maintaining Participant Records
  • Data Collection
  • Safety Monitoring
  • Reconsenting
  • Monitoring Consent Status

• Study oversight, maintenance and reporting

  • Regulatory File Maintenance
  • IRB Continuing Review
  • Amendments
  • Reportable Events
  • Regulatory Reporting
  • Data Management
  • Data Query Resolution
  • Study Monitoring/Audits
  • Budget Management

Study closure

• Study Close-Out Visit
• IRB Closure
• Archiving Records
• ClinicalTrials.gov Closure
• Post-Award Closure

Training

• CREW Program