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Investigational Drug Services

The Investigational Drug Services (IDS) support all clinical drug-related research conducted by investigators at Atlantic Health. The IDS provides the support needed to assure safe and efficient conduct of clinical drug trials including compliance with federal, state, and The Joint Commission on requirements regarding investigational drugs.

At each Atlantic Health institution, all investigational drugs are stored within a specially locked area to limit access by non-authorized personnel. The IDS maintains separate IDS refrigerators and freezers. Facilities are available for all extemporaneous compounding of oral, topical and parenteral formulations.  The IDS is able to dispense investigational medications to both inpatients and outpatients.  IDS policies and operation procedures are maintained by the Manager of Investigational Drug Services.  The IDS is open for inspection by all investigators and sponsors.  Inspections must be scheduled through the IDS Coordinator or Manager.

Services Provided by the IDS

The IDS is available for all clinical investigations approved by the Atlantic Health Institutional Review Board:

• Development of educational materials and training for patients and staff
• Drug information services and literature search related to investigational studies
• Assistance with protocol development
• Blinding methodologies
• Preparation of oral, rectal, topical, and parenteral dosage forms and matching placebo
• Limited access and security of study drugs
• Appropriate storage according to FDA guidelines
• Maintenance and control of investigational drug inventories
• Performance of randomization services such as IVRS for multicenter investigations
• Daily access to randomize, enroll and dispense study agents to consented subjects
• Maintenance of Drug Accountability Record Forms (DARF) and all study related files
• Collection of all patient drug returns and reconciliation
• Inventory control and return of all used and unused study drug to the sponsors
• Participation in final close-out of study protocols with the sponsors by providing copies of all drug disposition and inventory control records
• Drug destruction policies in place to destroy expired or used drug on site
• Participation in FDA, NCI, NIH and pharmaceutical sponsor audits
• Archives of all closed clinical study records for up to 15 years after termination

Special services:

• Computerized randomization schemes
• Special compounding of specially formulated active drug or placebo capsules, suspensions, or dosage forms commercially unavailable
• Preparation of blinded encapsulated study drug
• Assistance with pre-printed physician order forms

Initiating an Investigational Drug Study

The IDS requests a copy of the Sponsor’s Protocol and Investigator’s Drug Brochure. The Research Pharmacist will review the protocol, and meet with sponsor representatives, the principal investigator, study coordinator, and other study personnel to assess the potential IDS requirements. An IDS budget will be developed for the investigator to adequately plan for all necessary drug-related costs.