The Study Protocol or document describing a clinical trial scope of work:

  • Defines hypothesis, study objectives, study design, methodology, planned statistical analysis
  • Schedule of Events (i.e. table with procedures listed at each timepoint)
  • Protects the safety of the study subject
  • Ensures integrity of data collected

A study protocol authored by a sponsor is an industry initiated clinical trials. A study protocol authored by a Stanford investigator is an Investigator Initiated clinical trials (IIT) with industry funding.