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Services Provided

Services provided to the investigator by the UVaHS IDS include:

  • Assistance with protocol development
  • Randomization schemes
  • Blinding methodologies
  • Development of educational materials/in-service training for patients and staff
  • Preparation of oral, rectal, topical, and parenteral dosage forms and matching placebo
  • Appropriate storage according to FDA guidelines
  • Limited access and security of study drug
  • Maintenance and control of investigational drug inventories
  • Collection of all patient drug returns and reconciliation
  • Maintenance of Drug Accountability Records and all study related files
  • Participation in final close-out of the study protocol with the sponsor 
  • Return of all used and unused study drug to the sponsor
  • Drug destruction policies in place to destroy expired or used drug on site
  • Participation in FDA, NCI, NIH and pharmaceutical sponsor audits
  • Storage of all closed clinical study records for up to 15 years after closure
  • Preparation of study specific physician order forms and order sets for inpatient and clinic orders
  • Other special services as required