An investigator is required to maintain adequate records of the disposition of the drug, including dates, quantity, and use by subjects.21 CFR 312.62(a)
At UCSD, all investigational drugs or biologics (known as "test articles" or "Investigational Product (IP)") are handled by the Investigational Drug Service (IDS), a Division of the Pharmacy Department. Pharmacy services are critical to the success of clinical trials involving experimental drugs. The IDS pharmacists are active members of the research team, helping with the design of the study and participating in protocol review.
IDS Pharmacists are responsible for:
- Procuring & storing drugs
- Maintaining all study drug records regarding purchase, regulation & dispensing
- Compounding & dispensing study drugs
- Providing consultations to subjects enrolled in clinical trials
- Monitoring potential drug side effects in subjects enrolled in the studies
- Assuring quality control & compliancy
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IDS Recharge Rates