Expert Pharmacy Services for Research
Dedicated to the coordination of drug studies and safe dispensing of investigational drugs.
The Research Pharmacy (RP) is located in the central pharmacy area in University Hospital level B2 (room UHB2 D400). RP staff is comprised of pharmacists and technicians that are dedicated to the coordination of drug studies and to the dispensing of investigational drugs to inpatients and outpatients. The pharmacy staff in the decentralized pharmacy area dispense investigational drugs according to the guidelines established by RP.
For all drug studies, RP staff prepare and distribute Pharmacy Dispensing Guidelines that outline the Pharmacy's responsibilities for preparing, packaging, labeling, and dispensing the drug, as well as maintaining dispensing records. An investigational or study drug may be dispensed only upon receipt of a written order by a prescriber authorized by the Principal Investigator. All investigational drugs must be properly signed out of inventory and labeled according to state and federal guidelines with the required information such as the patient's name, directions for use, amount dispensed, prescriber's name, and the study drug name.
The RP staff ensures that hospital and pharmacy policies and procedures are followed for the preparation, handling, and disposal of investigational chemotherapeutic agents. All parenteral investigational agents are prepared aseptically according to pharmacy policy.
It is mandatory that accurate and appropriate inventory records are maintained for all study drugs that are received and distributed by the RP. Information on a drug accountability log includes but is not limited to:
- Receipt Date
- Dispensation Date
- Patient Identifier
- Quantity
- Lot Number
- Expiration Date
- Dispenser's Initials
In partnership with the study team and sponsors, the Research Pharmacy is responsible for ensuring adequate inventory levels are maintained on-site.
Expiration dates are checked and stock is rotated as needed. The final disposition of outdated study medications will be determined following sponsor authorization. At the end of the study, all medications are accounted for and properly returned to the sponsor. In addition, upon the termination of an investigational drug study, per FDA regulations, all inventory records shall be completed and stored for at least two years after the drug’s New Drug Application (NDA) is approved or its Investigational New Drug Application (IND) is terminated. However, the RP at Michigan Medicine retains all records until notified by the Principal Investigator or the study sponsor that the records can be discarded.
For additional information, visit the Research Pharmacy Website or review our Operations Manual.
Note: The links provided may require you to sign in using your Michigan Medicine (Level-2) username & password.
Hours of Operation: Monday - Friday, 8:00 am to 4:30 pm
Phone: 734-936-7469
Fax: 734-647-9302
After-hours, Urgent needs only: Pager #2944
Patient Care: [email protected]
- Signed paper prescription
- Requests to ship investigational products to patients (include completed intake form)
- IVRS and other treatment assignments
Inventory Issues: [email protected]
- Ordering and receiving issues
- Expiration and retest notices
Screening & Enrollment Notifications: [email protected]
- Identified and potential new subjects
- Any notifications impacting the patient or treatment plan
Requests Regarding New Studies: [email protected]
- Feasibility
- Budget
- Estimates
- Site Selection
- Waivers
Billing or Recharge Rate Questions: [email protected]
Monitor Visits: Click here to schedule (Tuesday - Thursday: 1:00 pm to 4:00 pm, by appointment only). [email protected]
Site Initiation Visits (onsite or remote), Audit Notifications, and Close-Out Notifications: Contact Lead Pharmacist. If unknown, email [email protected].
When contacting the Research Pharmacy, please provide:
- HUM Number
- Subject name, MRN, and/or study ID
- For blinded studies: indicate whether you are a blinded or unblinded study team member
- For medication returns: note whether it is a controlled substance
A preliminary estimate for Research Pharmacy services can be provided by submitting the Request for Research Pharmacy (RP) Review and Budget Estimate.
An overview and description of specific Research Pharmacy fees can be found here.
Fees are updated annually and reflect the real costs of RP services. Fees are agreed upon in consultation with the Department of Pharmacy Services and the Medical School Office of Research. Learn more about Research Pharmacy recharge rates.
To start working on a research medication order, you need:
- Completed prescription order (paper or electronic). Study-specific prescriptions can be found on the homepage of the Research Pharmacy Website under “Useful Links”
- IVRS/IWRS assignment or kit numbers with source documentation* (if applicable)
*Source documentation may include a screenshot, email, or other written communication
For a prescription to be considered complete:
- All required prescription elements – patient name, DOB, study ID, medication, dose, directions
- A valid signature or verbal authorization by an authorized prescriber
- Original, handwritten signatures or electronic MiChart signatures are permitted
- Note: PDF-certified signatures are NOT acceptable
- Electronic transmission of signed prescriptions by non-secure means is not acceptable (see also: Safe Computing Guidelines for protected health information)
- Original, handwritten signatures or electronic MiChart signatures are permitted
- Expected time needed. Please ensure you provide accurate time based on actual needs since this time is used to triage work.
- Preferred communication method for pickup alert
- Oral products: Average 30 minutes
- Injectable products: Average 1 hour
Note: ASAP orders will be prioritized, however, fulfillment time will be dependent upon the number of requests in our queue. Please ensure you provide an accurate pick-up time on the prescription based on the scheduled appointment time.
Incomplete or inaccurate prescription orders may result in delays.
For blinded studies: In order to maintain and protect the study blind we cannot provide precise wait times. We will provide standardized estimates only. Actual wait times may be longer than the provided estimate and will depend on the number of items in the Research Pharmacy queue.
Research medications are typically prepared in the following locations:
- University Hospital – Main Research Pharmacy housed within the UH central pharmacy (located on floor B2)
- C&W Hospital Inpatient Pharmacies – 7th floor or 10th floor
- Rogel Cancer Center Ambulatory Infusion Pharmacy
- Other (study-specific) – NOTE: these sites may require extra coordination and advanced planning to account for drug transport.
- Off-site locations – Brighton Center for Specialty Care, Northville Health Center, Allergy Specialty Clinic at Domino’s Farms
- Satellite pharmacies – as needed; examples include AES, CES, CVC, OR, and Ambulatory care pharmacies (e.g., Taubman center outpatient pharmacy)
Research medications can be retrieved by study personnel using one of the following methods:
- Pick-up from:
- Pharmacy where the medication was prepared
- Rogel Cancer Center Outpatient Pharmacy
- Taubman Center Outpatient Pharmacy
- Tube system (if medication can be tubed – refer to the study-specific dispensing guideline)
- Tip: Please clearly mark the tube station number on the order
- Tip: If you requested to have a medication tubed, please check the tube station first before calling the main research pharmacy to ask about the order status
- Hand delivery (limited circumstances)
- Tip: Please be as specific as possible when indicating the delivery location
- For example, instead of “C&W Hospital”, state “C&W Hospital 7th floor pharmacy”
- Tip: Please be as specific as possible when indicating the delivery location
The main research pharmacy has dedicated space within the central pharmacy on Floor B2, between UH elevators 2 and 3, across from Patient Food and Nutrition services (Room B2 D301).
For medication pickup: Enter through the back door of the pharmacy and use the phone to call the research pharmacy (x 67469) to let us know you have arrived. We will bring the order out to you when it is ready.
Please contact the Research Pharmacy directly for confirmation that a prescription can be shipped to a subject. The Research Pharmacy must first ensure that shipment will not be in conflict with any applicable regulations, institutional policies or sponsor policies (see below for general guidance).
Important: Shipping requests must be received by 1:00 pm on the day prior to when the patient needs to receive the drug. Shipping requests must be sent to [email protected] and must include:
- Completed prescription (see the section entitled “What is needed for a prescription to be considered completed?”)
- Completed shipping intake form
Other important shipping information:
- Shipping requests are processed Monday through Friday during normal business hours
- All shipping occurs via overnight air
- Shipping requests received by the 1:00 pm cutoff time on a Friday will be delivered Saturday
- Sunday deliveries cannot be accommodated
- Study medications CAN NOT be shipped to P.O. Boxes
- Study medications will be shipped with a signature required. Please ensure that patient or representative will be available to receive and sign for the parcel.
The information below serves as general guidance ONLY. Study-specific requests must be evaluated individually by the Research Pharmacy:
In general, if the research is being conducted under an Investigational New Drug application (IND):
- YES, we are permitted by law to ship within the United States.
If the research is NOT being conducted under an IND:
- Shipment within the state of Michigan is permitted
- Out-of-state shipments are subject to individual state laws
- In many cases, we are NOT permitted to ship across state lines
Courier services to off-site locations may be accommodated with coordination and approval from the Research Pharmacy, study team, and sponsor. Please contact the Research Pharmacy for more information.
Note that an additional fee applies for use of courier services to off-site locations.
In order to guarantee on-time delivery, three business days' notice is preferred for prescriptions for off-site patients. Please indicate the time needed and the specific off-site location on the prescription so that this information can be relayed by the Research Pharmacy to the courier.
Lead pharmacists serve as the first point of contact for study-specific questions and develop study-specific documents to facilitate the conduct of a clinical trial. In general, the lead pharmacist is assigned to studies by disease state. The study’s pharmacist will be listed on the OnCore Study Team.
If you are still unsure who the lead pharmacist for your study is, please email our pharmacist team at [email protected].
RP has integrated its administrative workflows into OnCore CTMS to enhance efficiency & transparency. Studies receiving RP support will have a management group called Research Pharmacy Service Utilization. New annotations have also been added to OnCore to accommodate RP data requirements.
The following RP administrative workflows are now OnCore task lists:
- Study start-up
- Amendment
- Hazardous drug
- Audits
- Study closeout
1500 East Medical Center Drive
Ann Arbor, MI 48109
Our Vision - To become the national leader in Research Pharmacy Practice and to advance research pharmacy standards on a global scale.
Our Mission - To educate current and future healthcare professionals about medication-related research, advance medication therapy by operationalizing research protocols in a safe and compliant manner, and collaborate with research and healthcare partners to safely and efficiently conduct quality medication-related research, as well as to progress the practice of research pharmacy
