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:
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One central site for investigational drug management ensuring compliance with federal
and state mandates and sponsor requirements.
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Assurance of adequate and accurate written records of receipt and disposition of all
drug supplies.
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Study design assistance
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Randomization and blinding
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Patient monitoring
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 ilabadmin@augusta.edu.
*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
information listed:
- Subject/patient's full name and initials, study ID#.
- Home address, date of birth, weight in kg for pediatric patients (or if drug dosed
by weight).
- Allergy status (list any known allergies to medications or "NKDA" for no known drug
allergies).
- 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
team member.