Clinical Trials Administrative Start-Up Handbook

SECTION 2

RESEARCH SERVICE CENTERS

General Information

About this Section
Commonly required procedures for clinical trial protocols include laboratory processing and testing, x-rays, CT scans, MRIs, ECGs, pathology services, and the receipt, handling, and storage of investigational drugs and other products. Although not comprehensive, the following list includes information about several services frequently used by clinical trials investigators:

• Investigational Drug Service at the University of Washington Medical Center
• Investigational Drug Service at Harborview Medical Center
• Radiology Research Services at University of Washington Medical Center
• Radiology Research Services at Harborview Medical Center
• Laboratory Services
• Northwest Lipid Research Laboratories (NWLRL)
• Cardiology Diagnostic Services at University of Washington Medical Center
• Cardiology Diagnostic Services at Harborview Medical Center

Links to forms, names and telephone numbers of various service centers are included in this section of the Handbook. Service center contact people will answer pricing questions and will discuss scheduling plans with you.  Although these contacts are available for questions at any time, pricing information is usually available only if you have first sent the completed Clinical Research Pricing Pages to the contact people in the service centers you will use for your study.  The Clinical Research Pricing Pages are part of the AAA Packet, available from the Clinical Research Budget and Billing (CRBB) Office Web site.

Investigational Drug Service (IDS) at the University of Washington Medical Center (UWMC)

About the IDS at UWMC
Upon request, the Investigational Drug Service (IDS) is available to investigators at the University of Washington Medical Center (UWMC). IDS provides accountability, handling, storage, and control of investigational drugs and assures compliance with the standards of the FDA and of the study sponsor. IDS works with you and with the study sponsor, providing services that include:

• Ordering and receiving study drug. IDS will assume responsibility for all aspects of ordering and receiving study drug.
• Maintaining drug inventories and patient dispensing records. IDS will maintain accurate records of study drugs received. IDS works with you to develop dispensing procedures that comply with FDA and medical center guidelines. Drug accountability and patient dispensing records will be available for review by you, by study sponsors, and by the FDA. For multi-site studies, IDS will arrange to ship drug to other sites or to coordinate drug use among multiple sites.
• Providing secured storage of study drug. IDS uses secured facilities of the Department of Pharmacy to insure proper storage of study drugs as required by federal regulations and by study sponsors. IDS maintains freezer and refrigerator space that is monitored and alarmed to ensure proper storage conditions for investigational medications.
• Labeling and packaging of study drug for patient use. IDS packages and labels study drugs for dispensing to study subjects in accordance with sponsor guidelines and with federal and state law.
• Blinding and randomization procedures. IDS will assist you in the development of randomization schedules and will ensure appropriate blinding as required by study protocols.
• Providing drug information. IDS will provide you and your study associates with drug information regarding investigational drugs, including adverse effects, contraindications, administration guidelines, stability, compatibility, and drug interactions.
• Ensuring final drug disposition. IDS will assume responsibility for return or disposal of unused or expired study drugs and will maintain records of these transactions.

Best Practices for Using the IDS at UWMC

• For IDS pricing information, complete the "Investigational Drug Services" Clinical Research Pricing Page and send it to the UWMC IDS key contact person.  The IDS Pricing Page is part of the CRBB Detail Budget Tool, available from the CRBB Online Toolkit referenced and discussed under General Information, above. 
• Do not assume that IDS fees will be the same from study to study. Fees are subject to annual adjustment but are also based on variables such as the drug's route of administration and on items such as blinding, randomization, or multi-site coordination. Before quoting a budget figure to the study sponsor, obtain price quotes from the IDS.
• Notify the IDS about all clinical trials using investigational drugs at the UW, regardless of whether you choose to use IDS services. Although not a requirement, such notification will allow IDS to address important safety issues. For example, the IDS may be the first place to be called if a UW patient on a study drug presents with an adverse event at a UW clinic or elsewhere. Such patients may have unlabeled drugs and be unable to identify their treating physician, making it impossible for the clinic to identify the drug or the study in which the patent is participating. If the IDS is aware of all clinical trials at the UW, they may be able to provide emergency drug information or appropriate study contact information to the clinic personnel who are treating the patient. You can notify IDS either by sending them a copy of the study protocol or by simply calling them to tell them about your study.

Key Contacts

UWMC IDS
Box 356015
Phone: 206-598-6054
Fax: 206-598-4901

Investigational Drug Service (IDS) at Harborview Medical Center (HMC)

About the IDS at HMC
The Investigational Drug Service at Harborview is available to all investigators who request its services. The HMC IDS coordinates with physicians, drug sponsors, nurses, research coordinators, and the UW Human Subjects Committees to ensure the best outcome and to satisfy all requirements for investigational drug studies and human subjects compliance.

The HMC IDS provides services that include:

• Assistance with study design and set-up, including the creation of randomization tables and blinding methodologies
• Help with IND submissions.
• Development of educational materials and inservice training.
• Preparation of oral, parenteral, rectal, and topical dosage forms with matching placebo.
• Preparation and adherence to pharmacy protocol procedures, including study notebooks, documentation of study drug inventory, storage and accountability, and drug returns/reconciliation/disposal.
• Twenty-four hour access to enrollment, randomization, and dispensing of investigational drug.
• Counseling to research subjects regarding the study drug's dosing, mechanism of action, side effects, food and drug interactions.
• Participation in sponsor and FDA audits of clinical trials.
• Archives for all pharmacy-related documents, including consent forms, for a minimum of fifteen years.

Best Practices for Using HMC IDS

• For IDS pricing information, complete the "Investigational Drug Services" Clinical Research Pricing Page and send it to the HMC IDS key contact person.  The IDS Pricing Page is part of the CRBB's AAA Packet referenced and discussed under General Information, above.
• Complete the "HMC Faculty Notice of Intent to Initiate Research or New Clinic-Based Services" form. This form is required in order to request any research service at HMC. The form and instructions for completing it are available just below the AAA Packet information on CRBB's Web site.
• Involve the IDS early in the planning process for your trial. Early discussions with IDS will enable you to budget accurately and to take advantage of the wide range of assistance and advice offered by IDS.
• Do not assume that IDS fees will be the same from study to study. Fees will vary depending on the complexity of your protocol and of the investigational drug.
• Remember that all IDS fees are due regardless of actual subject enrollment in the study. This means that you will need to negotiate the IDS setup fee as part of the non-refundable start-up payment from the study sponsor.
• Remember that IDS fees are subject to change. Inflationary adjustments and other price changes will influence budgets, especially for long-term studies, and IDS will discuss this with you in the budget planning process.
• Take all protocol amendments to IDS, regardless of whether the amendment includes an IDS-related change. IDS-related changes may or may not require fee adjustments.

Key Contact

HMC IDS
Phone: 206-731-5448
Fax: 206-731-5140
Address: 325 9th Avenue
               Box 359885, GEH27
               Seattle, WA 98104-2499

Timeline
Price quotes will be available from HMC IDS in less than two weeks. Complicated studies might take the full two weeks; less complicated studies will take less time.

The study initiation and preparation process may take two to three weeks, depending on the complexities of your protocol and the investigational drug.

Radiology Research Services (RRS) at UW Medical Center (UWMC)

About RRS at UWMC

Two types of scanning devices are available for radiology research imaging services at the UWMC:

Dedicated (research) scanners:

• the Magnetic Resonance Research Laboratory, located in the Diagnostic Imaging Sciences Center (DISC). Visit the MR/ DISC Web site for complete information about services offered, pricing, the application process, and more.
  
• the Bio-molecular Imaging Center (BMIC), located at the South Lake Union Campus. Visit the BMIC Web site for complete information about BMIC policies, services offered and about scheduling new studies - including application forms, price quotes, and time slots. Questions can be answered by the BMIC Key Contact.

Clinical scanners:

• the Radiology Clinic, located at UWMC and Roosevelt. The Radiology Clinic provides CT, MRI, ultrasound, nuclear medicine, diagnostic radiology, ultrasound, nuclear medicine, positron emission tomography (PET), PET/CT and diagnostic (plain film x-ray) imaging. Estimated price quotes and other start-up advice are available by submitting the Radiology Services Pricing Page and the UWMC Initial Radiology Research Form (scroll to "AAA Packet and other Start-Up Forms"), along with your study protocol, to the Radiology Research Committee (RRC).

All radiology service providers will help you complete the appropriate start-up forms and will discuss your trial with you. For example, the radiology service providers will want to know how many subjects are expected over what period of time and to discuss whether your subject population has any unique characteristics that might require special preparations, e.g., geriatric, mentally confused, frail, obese, infectious.

Best Practices for Using the UWMC Radiology Research Services

• Read about the the DISC Magnetic Resonance Research Laboratory services, scheduling, policies, and procedures.  To maximize magnet time during a scan session, ask subjects to complete the MRI Subject Screening Form in advance and bring it to the scheduled session.
• Prior to submitting the Project Information Form to the DISC Magnetic Resonance Research Laboratory, investigators may call Dr. Ken Maravilla to discuss their new project or to obtain help in structuring the MR portion of the project.
• Note that some of the radiology research service providers' forms request information that may not be available when you complete them, e.g., UW budget numbers and/or AAA account numbers and Human Subjects Review Committee approvals. You can indicate that the information is pending and submit it later, but you must submit this information prior to provision of services.
• In order to ensure that your original arrangements remain current, keep in touch with the radiology research service providers during the administrative startup phase of your study. If significant time elapses during the startup phase, protocol amendments and/or price changes may occur that will affect the original price quotes.
• Schedule subjects for research procedures as far ahead of time as possible. Schedules are tight. None of the service providers can accommodate drop-ins.
• When calling to schedule appointments, remember to tell the service provider that the appointment is for a research procedure for an approved clinical trial.
• Call the service provider as soon as possible if you need to cancel an appointment. Note that some radiology service centers have specific cancelation policies.

          Key Contacts

Diagnostic Imaging Sciences Center (DISC)

Ken Maravilla, MD
Director, MR Research Laboratory
Box 357115
Phone: 206-685-0457
Fax: 206-543-3495

mrlab@u.washington.edu
Administrative Coordinator
Box 357115
Phone: 206-685-0457
Fax: 206-543-3495

UWMC Radiology Clinic

Radiology Research Committee
Box 357115
Phone: 206-616-0962

Bio-molecular Imaging Center

bmic@u.washington.edu
Box 358050
Phone: 206-543-3061
FAX: 206-616-9354
Directions to BMIC

Timeline
Research price quotes from the UWMC pricing system will usually be available within about 10 working days, but the DISC request may take longer if the request is complicated.

Radiology Research Services (RRS) at Harborview Medical Center (HMC)

About RRS at HMC
Investigators should call the HMC Radiology Research Coordinator to discuss budgets and scheduling as soon as plans for the clinical trial become fairly firm. To provide you with the services you need, the Radiology Research Coordinator will need to know what services are required, how many subjects are expected over what period of time, and whether the required services will need to be read by a radiologist.  The Radiology Research Coordinator will also need to know if the subject population has any unique characteristics that might require special preparations, e.g., geriatric, mentally confused, frail, obese, infectious.

HMC Radiology welcomes and encourages clinical research and will do its best to provide you with prompt and accurate cost information. Initial cost quotes will be very close to the final figures, but there is always a possibility that the final price may vary from the original quote. Such variations may be caused by unpredictable factors, by protocol information not obvious from the original description of the project, or by changes in the level of radiology involvement.

The Radiology Research Coordinator will make every effort to provide you with reliable, fail-safe scheduling for research radiology procedures. However, because all of the equipment is heavily used and may be required on short notice for emergencies or for priority patient care, last minute changes may be necessary.

Best Practices for Using the RRS at HMC

• For RRS pricing information, complete the "Radiology Services" Clinical Research Pricing Page and send it to the HMC RRS key contact person.  The RRS Pricing Page is part of the CRBB Detail Budget Tool, available from the CRBB Online Toolkit referenced and discussed under General Information, above.
• Call the Radiology Research Coordinator to discuss the study protocol as soon as possible.
• Keep in touch with the Research Coordinator during the administrative startup phase to be sure that your initial budget quotes are current. If significant time elapses during the startup phase, protocol amendments and/or price changes may occur that will affect the original price quotes.
• Notify the Research Coordinator about the Human Subjects Review Committee and the Radiation Safety Committee approvals as soon as possible. The radiation procedures cannot be done without these approvals.
• Be sure that each research subject has been registered as an HMC patient. Procedures cannot be scheduled without a current HMC registration number.
• Be sure to discuss the blue Diagnostic Imaging Request Form (available by calling 206-731-3105) with the Research Coordinator before you complete the form.
• Schedule some procedures (e.g., MRI) as far in advance as possible. Advance scheduling for other procedures (e.g., chest x-rays), is not necessary.
• Discuss with the Research Coordinator whether to send a member of the research team along with the patient. It is best for the patient to be accompanied if the procedures are complicated or if the patient is impaired. The Research Coordinator will be able to advise you about this, and may be able to assist the patient.
• After the trial has begun, the administrative track may differ, depending upon the complexity of the procedures you are requesting.  Keep in touch with the Research Coordinator, who will explain the track you need to follow.

Key Contact

Stephanie Pardee
Radiology Business Manager
Box 359728
Phone: 206-731-8761
Fax: 206-731-8560

Timeline
Most cost information is available within a day or two, but complicated or unusual requests may take longer.

Laboratory Services

Department of Laboratory Medicine

The Department of Laboratory Medicine has two pathways for performing research tests.  Please do not initiate a study without prior consultation with the Department. The two pathways are:

1. Research Testing Services (RTS). 
   • RTS tests are batched (no STAT work)
   • RTS tests are charged directly to your study's budget number, not to an AAA account.
   • Test results from RTS do not become part of the subject's medical record.
     
2. "AAA" research testing pathway (tests required and paid for by a study, but also part of standard clinical care).
   • Tests are done in a standard clinical fashion (STAT work is included)
   • Tests are billed to the study's AAA account.
   • Test results are entered into the subject's medical record so that the results can be used for clinical care.

To obtain research prices from Laboratory Medicine testing services:

• Call the key contact person at RTS and describe your project.  Based on your description and a discussion of your needs, RTS will determine which research testing pathway (RTS or AAA) is appropriate for your study.  RTS will then either help you directly or will refer you to the key contact person for AAA research tests.
• For pricing information from either of the two research testing pathways, complete the Laboratory Services Clinical Research Pricing Page, available from the CRBB Online Toolkit that is referenced and discussed under General Information, above. Send the Laboratory Services Clinical Research Pricing Page to the research testing pathway that you have decided is appropriate for your study.

Best Practices for using Laboratory Medicine

If using RTS:

• After you have received your study budget number, complete and return the RTS Application Form as soon as possible (RTS needs time to prepare for your study). RTS will not accept samples without a budget number - it is the means by which your lab reports will be identified and mailed. After your study has begun, be sure to notify RTS if your budget number changes.
• Discuss specimen collection and handling procedures in advance.  Refer to the Research Testing Services - Instructions for Researchers for essential information about labeling and processing instructions.

If using AAA research testing services

• After you have received your AAA Account Number, request the purple request forms (Special Billing forms) via email from Laboratory Medicine AAA testing pathway staff. Always use the purple forms when ordering tests through Laboratory Medicine's AAA testing pathway.  Mistakes will happen if you don't use the purple forms, e.g., test charges may be billed to subjects rather than to your AAA research account, and test results may not reach subjects' medical records.
• Remember that the purple forms must include the patient's name, the patient's medical record number, and the clinic or inpatient unit where the patient is being seen.

Laboratory Medicine testing services key contacts:

Research Testing Services
RTS staff
Box 358051
Telephone 206-616-8979
FAX: 206-685-6046

AAA testing services
LabMed Coodinator
Box 359743
Telephone: 206-744-9197

Laboratory Medicine Research Testing Service Timelines

RTS timelines:

• Allow 1-2 weeks to receive the standard green request forms from RTS.
• Allow 4-6 weeks to receive the customized green request forms from RTS.

AAA testing timelines:

• Laboratory Medicine will return the completed Laboratory Services Pricing Page to you within one week (likely sooner, but dependent upon staffing and backlog).
• Laboratory Medicine will return the purple request forms to you within 2 weeks of the day that you notify them of your AAA account number.

About Northwest Lipid Research Laboratories (NWLRL)
NWLRL is a core laboratory within the Division of Metabolism, Endocrinology, and Nutrition. The NWLRL specializes in lipoprotein and apolipoprotein research, offering tests of cholesterol, triglycerides, and other blood lipids, as well as more complex or specialized tests involving determination of lipoprotein content. NWLRL works cooperatively with RTS to perform these specialized tests and to report the results to you.

Key Contacts

For budget information:

Trisha Speer
Manager
Phone: 206-685-3339
Fax: 206-685-3279

For study consultation or technical information:

Dr. Santica Marcovina
Laboratory Director
Phone: 206-685-3331
Fax: 206-897-1815

Cardiology Diagnostic Services

About Cardiology Diagnostic Service
Cardiology procedures are provided to investigators at UWMC and HMC by several different services. UWMC and HMC cardiology services have different methods for providing prices.

The cardiology diagnostic services do not have pre-configured research pricing pages, so you will need to create your own.  To do this, go to the AAA Pricing Request Forms section of the CRBB Detail Budget Tool, and check the "Other" box.  Enter "Cardiology Diagnostic Services" in the field by the checkbox.  Then, complete the form that you have created and send it to the appropriate UWMC or HMC key contact person.  The CRBB Detail Budget Tool is available from the CRBB Online Toolkit referenced and discussed under General Information, above.  Then:

• Call the appropriate Key Contact, either at HMC or at UWMC and follow the "Best Practices," below.

Best Practices for Using Cardiology Diagnostic Services

• Inquire about scheduling arrangements for the cardiology service that you require. These may differ from service to service. For example, some services may require that a physician be on site during the procedure.
• Discuss your project with the cardiology service, including any unique characteristics of your study population or special preparations that might affect costs.
• Inquire whether the cardiology service requires written information before quoting prices. For example, the Echo Lab is likely to require a copy of your protocol in order to determine exactly what data are needed for your trial.
• Inquire whether the cardiology service requires its own specific application and approval process before providing services.
• Keep in touch with the cardiology service during the administrative startup phase to be sure that your cost information is current. If significant time elapses during the startup phase, protocol amendments and/or price changes may occur that will affect the original price quotes.
• Schedule subjects for research procedures as far ahead of time as possible.
• When arriving for the procedure, inform (or instruct unescorted patients to inform) the cardiology service that the procedure to be done is for "Dr. X's research study." This will enable the service to match the patient with prior application materials, if appropriate.

Key UWMC Contacts

Alaina Clinton
Manager, Clinical Billing and Reimbursement
Box 356422
Phone: (206) 598-0531
Pager: (206) 989-0014
Fax: (206) 616-4847

Alaina can help you with research prices for all of the following services:

1. ECG Laboratory (electrocardiograms, treadmills, Holter monitoring, arrhythmia monitoring)
2. Echo Laboratory (echocardiograms)
3. Electrophysiology Laboratory (electrophysiology studies, catheter ablation procedures, pacemaker implants, defibrillator implants, tilt-table testing)
4. Heart Catheterization Laboratory (coronary interventions and angiograms, Swan-Ganz placements, right heart catheterizations, intracoronary ultrasound, thrombolytic therapy)

Key HMC Contacts

ECG Laboratory (electrocardiograms, treadmills, Holter monitoring, arrhythmia monitoring):

Ty Hood
Manager (for cost information)
Box 359748
Phone: 206-744-3469
Fax: 206-744-2224

Richard Johnson
Scheduling Coordinator
Box 359748
Phone: 206-744-8448
Fax: 206-744-5996

Echo Laboratory (echocardiograms):

Eric Sisk
Supervisor (for cost information)
Box 359748
Phone: 206-744-8448
Fax: 206-744-5996

Richard Johnson
Scheduling Coordinator
Box 359748
Phone: 206-744-8448
Fax: 206-744-5996

Timeline
Turn-around times will differ by service. Call to discuss your project prior to submitting budget information to the sponsor.