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210601P - PLANNING A CLINICAL TRIAL

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Presentation prepared by Dr Omar Hasan Kasule Sr MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Professor of Epidemiology and Bioethics King Fahad Medical City.


STAGE 1:

  • Research question/hypothesis
  • Funding: grant or pharma sponsor
  • Development of the investigational product in the laboratory
  • Animal testing
  • Synopsis of the study
  • Selection of the site(s)


STAGE 2:

  • The protocol
  • The investigator brochure
  • Consent documents
  • Contracts and insurance
  • Regulatory submissions
  • Start-up meeting with investigators


STAGE 3:

  • Recruitment strategy
  • Review CRF and source document templates
  • Site and trial master files
  • Obtain regulatory approval
  • Site initiation meeting
  • Staff training
  • Receipt of the investigational product (IP)


STAGE 4:

  • Clinical conduct of the trial
  • Database lock
  • Close-out meeting
  • Archiving
  • IP destruction
  • Publish results
  • Submit for drug registration


NOTES:

Adapted from  A Comprehensive and Practical Guide to Clinical Trials  Edited by  Delva Shamley and Brenda Wright. Pages 6-8. Elsevier 2017