Overview of Investigational Drug Services
According to 21 CFR 312.62(a), an investigator is required to maintain adequate accountability records for the investigational drug or biologic. At UCDHS all investigational drugs or biologics (also known as “test articles”) are handled by the Investigational Drug Services (IDS), a Division of the Pharmacy Department. IDS stores and dispenses drugs in accordance with Good Clinical Practice Guidelines, the study protocol requirements, and all applicable rules and regulations.
IDS is responsible for:
- Establishment of Standard Operating Procedures (SOP) for each study ( copy for Sponsor and a copy for Investigator’s file);
- Proper storage conditions (Temperature logs and Documentation of excursions)
- Segregation of study agents by protocol
- Isolation of expired and damaged study agents
Prescribing investigational drug
Only the PI and sub-investigators listed on the FDA Form 1572 may write orders for study agents. In addition, prescriptions can be issued by:
Authorized Prescribers List”
Clinicians on “IRB Research Personnel List”
Prescription must contain ALL information currently required by state, federal and institutional laws and policies, including: name & address of patient; name & quantity of drug; date of issue; typed or printed name, address and phone# of prescriber; signature of prescriber.
Clarification on investigational drug dispensing, transportation and administration:
1. Please review P&P 1508 "Distribution of Investigational Drugs" (updated 11/16/2011)
2. According to UCDHS currently established best practices, unlicensed research personnel can pick up the outpatient investigational drugs from the IDS Pharmacy (its central or satellite locations) for the purposes of transportation to the study subject. The research personnel should be authorized to do so by the Principal Investigator on the Delegation Log for the study. The investigational drugs are provided in tamper-evident package (stapled). The patients should inform their physician if the seal was broken upon the receipt of the package.
3. If the protocol requires the study drug to be administered during the study visit, then in accordance with P&P 1508 only physician, nurses and authorized licensed personnel is able to administer the investigational drug or any other concominant medication.
IDS Fee schedule
IDS charges the start up fees (non-refundable, one time set-up charge) and the dispensing fees. Download the form for estimation of charges.
Information required for study set-up
IRB#, expiration date, # of subject approved
Investigator brochure (IB)
Sponsor provided supplies ( labels, drug logs, forms, etc)
Drug Accountability Forms
Drug Accountability Form or DARF contains:
- Drug’s name, dosage form, strength, lot number and expiration date
- Dispensing Information:
- Subject info (ID, initials, etc)
- Quantity dispensed/received/wasted
IDS also maintains randomization codes of patients receiving the drug. As a rule, treatment should not be unblinded except under emergency conditions, which are typically described in the protocol. Before unblinding, the process should be discussed with the study sponsor.
Disposal of investigational Drug
At the conclusion of the study, the pharmacist returns, transfers or disposes of all unused investigational drugs according to the specific instructions provided by the sponsor or sponsor-investigator. Download Return/Destroy form here
IDS may administer dietary supplements if the research involves the use of a supplement to treat a disease (intended for use in diagnoses, cure, relief, treatment, or prevention of disease or intended to affect the structure or function of the body), or involves significant risk to subjects. In these cases, the FDA requires submission of IND (Investigational New Drug) Application for this dietary supplement. For the studies under INDs, the supplement will be treated as investigational drug.
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