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Services Provided by the
IDS
Services provided to the
investigator by the University of Kentucky 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
- 24-hour-a-day access
to randomize, enroll and dispense study to consented subjects
- Performance of
centralized telephone randomization services for multicenter
investigations
- 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 by providing copies of
all drug disposition and inventory control records
- 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
- Special services:
- Special Compounding of specially
formulated active drug or placebo capsules, suspensions, or dosage
forms which are not commercially available
- Preparation of blinded encapsulated
study drug
- Assistance with pre-printed physician
order forms
- Other special services
as required
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