Virtual Facilities Tour

Oncology Clinical Trials Support Unit (O-CTSU)

The Oncology Clinical Trials Support Unit (O-CTSU) serves as the centralized core facility of all clinical research trials conducted by investigators at the University of Michigan Rogel Cancer Center (UMCCC). This includes investigator-initiated (II), peer reviewed clinical trials, NCI-CTEP approved protocols, pilot transitional institutional studies, cooperative group trials and industry sponsored trials. The O-CTSU offers a broad range of expert services to investigators to help them facilitate the conduct of their studies according to federal regulations and GCPs.

Ravitz Cancer Center Research Unit (CCRU)

The Ravitz CCRU is located within the Rogel Cancer Center at the University of Michigan Hospital and Health Centers. The unit is comprised of six chairs for patients participating in Phase I oncology clinical trials or Phase II or III complicated oncology clinical trials. The unit is staffed with four, research focused registered nurses and three medical assistant specialists. Treatments given in the unit can include Investigational, chemotherapeutic and biologic both intravenous and oral administration. The Ravitz CCRU capabilities include: timed blood draws, urine and pharmacokinetic and pharmacodynamics sampling, oral investigational agent on site administration and investigational study drug accountability and compliance, as well as patient education related to both study medication and clinical trials. The unit has access to emergency medical equipment which includes a crash cart located within the unit and access to the UMHHC Code team. The unit is also equipped with two standard of care ECG machines and DASH 4000 vital sign monitoring device.

For studies with special requirements outside CCRU scope, CC investigators will also partner with the MICHR Michigan Clinical Research Unit (MCRU).

Clinical Research Specimen Processing (CRSP) Unit

CRSP is committed to providing quality services in support of UM oncology research. CRSP provides research sample processing, aliquoting, storage and shipping, including chain of custody documentation of sample receipt through distribution, processing per protocol specific guidelines, freezer storage, as required and same day and/or batch shipments. Samples may be blood, urine, bone marrow aspirate, hair, saliva, stool, complex PK profiles, paraffin embedded tissue blocks or slide recuts. CRSP performs peripheral blood mononucleated cell count procedures and limited fresh biopsy sample processing (fresh samples received in formalin, or requires transfer to 70% ethanol). University resources are available to collect and process biopsy samples into paraffin embedded block, make touch preps, and do snap frozen samples requiring use of liquid nitrogen; CRSP will provide distribution of these research samples.

CRSP maintains two -80°C freezers, one -20°C freezer, one refrigerator and several centrifuges, including one with variable temperature control. Dry ice is readily available. Samples stored frozen for later batch shipments will be shipped monthly to sponsor or sponsor’s vendor. CRSP has ample but not unlimited freezer storage and will not retain samples for shipment until end of study.

CRSP staff is trained on the protocol, lab manual(s), updates and amendments to provide appropriate specimen handling, processing, storage, packaging and shipment notification of subject research samples according to protocol/lab requirements outlined for each study. Documentation of training is maintained within CRSP and is available upon request. CRSP personnel are International Air Transport Association (IATA) certified and have extensive experience working with a multitude of vendors. Specific CRSP policies are available upon request.

Day	Hours	Time of Last Shipment
Monday – Thursday	7:30am to 7:00pm	FedEx: 6:30pm
Friday	7:30am to 5:00pm	UPS: 4:00pm

Research Pharmacy (RP)

This is a virtual tour of the Research Pharmacy of the University of Michigan. It is supplemented by policies that provide more details on the operation of the service. As part of this presentation you are provided with a link to few key policies. Please review these policies carefully and contact the Research Pharmacy lead pharmacist for the study with any questions or issues.

The Research Pharmacy is located on the lowest level of the main University of Michigan Hospital building and is part of the central hospital pharmacy. This pharmacy is locked and only authorized pharmacy staff can access the area using a card key. All visitors must sign in upon entry and are escorted by pharmacy staff during their visit.

Stepping into the main Research Pharmacy area you see working stations, color coded binders, and a drug storage carousel. The area is staffed by a pharmacist and pharmacy technicians and is mainly used for study drug receipt and distribution and for drug dispensing.

Each research pharmacist is assigned a color and several specific therapeutic areas and is the lead pharmacist for studies in this area. The binders are color coded by pharmacist and contain essential documents for the daily conduction of the study. They include items like the study subject list, accountability logs, dispensing guidelines and drug receipts. The protocol, Investigator’s Brochure and other study documents are stored in hanging files or electronically.

All study drugs are shipped to the Research Pharmacy. Drugs are received by the Research Pharmacy staff according to the sponsor instructions and are stored according to the drug storage specification. All study drugs are stored separately from other drugs in the Pharmacy to prevent loss or use by unauthorized Pharmacy personnel. The drugs are accessible 24 hours per day 7 days a week.

In the Research Pharmacy room temperature drugs are stored in a carousel that uses bar code technology. Refrigerated or frozen drugs are stored in dedicated refrigerators and freezers in color coded bins that are marked with the study number. Currently the service maintains several refrigerators, a freezer that is set at between -15 and -25C and an ultra-cold freezer that is set at between -75 and -85C. Limited quantities of investigational drugs may be supplied to decentralized pharmacy areas like pharmacy satellites or ambulatory care pharmacies, when the decentralized pharmacy serves as a more expedient site from which the drug may be dispensed to the subject. Storage conditions in the decentralized area are the same as the conditions in the Research Pharmacy.

Storage temperatures in the Research Pharmacy and decentralized area are maintained according to the USP 29-NF 24 Guidelines and are monitored continuously 24 hours per day seven days per week using an FDA-approved system called TempTrak. Additional information on temperature monitoring and handling of excursions is available in a policy that is provided to you for review.

Monitors can visit the area by appointment. Typically appointments last one hour and are made through the study coordinator or data manager who contacts the pharmacy and coordinates the appointment. Since our schedule fills up fast, monitors should schedule the visit at least two weeks in advance and notify us of a cancellation at least 24 hours in advance. If more than one hour is needed, it should be requested at the time the scheduling. During the visit the monitor is assisted by a research pharmacy technician and has access to a copier. The study drugs, the accountability and the temperature logs are all available for review. For studies that utilize a pharmacy satellite, if time and staffing allows, the monitor will be escorted to the Satellite to review the drug and records. Otherwise, satellite records and drugs will be available for review at each visit. Drug disposition or return to the sponsor takes place during the monitoring visit. More information on monitoring our site is available in the provided policy.

At the site initiation the lead pharmacist discusses the study details with the sponsor and the study team and agrees on the process to be followed. Ideally, the Research pharmacy staff prefers to use the institution accountability logs and standard processes that are established at the institution.

• Policy 400.01 Authorized Prescribers
• Policy 400.02 Drug Accountability & Inventory Maintenance
• Policy 400.03 Use of Decentralized Rx Area & Intra-Institutional Drug Transport
• Policy 400.04 Funding and Fee Structure
• Policy 400.05 Inspection of other Investigational Drug Storage Areas
• Policy 400.06 Delegation of Authority, Training, and Credentials
• Policy 400.07 Alternative Access Programs, Tx INDs, Emergency Use INDs
• Policy 400.08 Temp Monitoring
• Policy 400.09 Monitoring Visits
• Policy 400.10 Essential Document Handling & Retention

Request to deviate from polices or processes can be submitted using a specific form. Requests are considered and if granted may result in an additional charge. These requests should be made within 14 days of receiving the policies, so that any issues can be resolved prior to the site initiation.

Thank you for considering the University of Michigan for your study.