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