The AU Medical Center pharmacy has been assigned responsibility for study medication
receipt, storage, dispensing, accountability and record-keeping for all human subject
research on campus.
The Clinical Research Pharmacy provides:
One central site for investigational drug management ensuring compliance with federal
and state mandates and sponsor requirements.
Assurance of adequate and accurate written records of receipt and disposition of all
Study design assistance
Randomization and blinding
To initiate your research study with the clinical research pharmacy, please go to
iLab and create a new study. Instructions and assistance are available here or by contacting firstname.lastname@example.org.
*INFORMATION NEEDED PRIOR TO DISPENSING FIRST STUDY MEDICATION*
- Copy of the subject's signed/dated informed consent.
- Written prescription signed by a physician/investigator with the following additional
- Subject/patient's full name and initials, study ID#.
- Home address, date of birth, weight in kg for pediatric patients (or if drug dosed
- Allergy status (list any known allergies to medications or "NKDA" for no known drug
- Medical Record Number for that patient (not dummy study ID or study account number).
- Short name of study/study drug and protocol number for study.
*PROCESS FOR DISPENSING (WHEN KNOWN IN ADVANCE)*
- Provide written prescription at least 24 hours in advance.
- The pharmacy staff will have the Rx available for pick up in the central Clinical
Research Pharmacy (2nd floor hospital, BI-2101) on the day of the visit. Oncology
Rx can be picked up at Cancer Center Pharmacy.
*PROCESS FOR DISPENSING (DURING VISIT )*
- Notify the pharmacy in advance of your anticipated needs whenever possible (e.g.,
if screening for new patients, what hours/days are your clinics -- for returning patients
you should provide a list of return appointments).
- Provide a prescription from a physician investigator by one of three methods:
- Drop off prescription to Clinical Research Pharmacy staff (BI-2101).
- Fax copy of prescription to 721-4099 (the pharmacy staff will get the original prescription
when the study drug is dropped off/picked up).
- Have the investigator call in the prescription or dose adjustment to the pharmacist
via Imprivata Cortext.
- Filled prescription will be picked up by the study coordinator/investigator or research