IDS Pharmacy

Pharmacy Hours:
Hours of operation: Mon–Fri, 8:00 a.m.–7:00 p.m. (last Rx received by 4:45 p.m.)
(weekend/holiday dispensing on-call basis based on clinic open and advance approval)

Pharmacy Shipping Address:
ATTN: Investigational Drug Services,
Pharmacy G5-920,
Fred Hutchinson Cancer Center,
825 Eastlake Ave East
Seattle WA 98109

The Fred Hutch IDS Pharmacy provides services in accordance with FDA recommendations by applying standards set by the Good Clinical Practice (GCP) guidelines. IDS Pharmacy Standard Operating Procedures (SOPs) adhere to policies set forth by the Fred Hutch Pharmacy's Policy and Procedures Manual, as well as federal, and state guidelines.

Sponsors are provided with a copy of IDS Pharmacy Full SOP following site qualification. Sponsor review and acknowledgement of receipt of IDS Full SOP will be required for all studies requiring IDS involvement.

• Fred Hutch IDS Pharmacy is adequately staffed to perform blinded and un-blinded studies.
• Investigational drug supplies are stored in clearly labeled, designated areas, separate from standard pharmacy stock, according to conditions specified by the protocol.
• All investigational drugs are kept locked at all times and are accessible only to authorized personnel.
• Each study for which investigational drugs are supplied has a file holding the drug accountability, drug shipments received, and subject dosing information. Fred Hutch utilizes Vestigo®, a web-based software, to manage investigational drug records used in clinical trials. Vestigo® employs electronic drug accountability record forms (eDARFs) Records are retained for a period required by federal law or the sponsor, whichever is longer.

Disposition & Destruction of IP

• All vials used for the preparation of investigational drugs will be documented as destroyed onsite on the accountability log upon usage.
• Unused or expired study medications will be documented and destroyed. Used medication bottles will be documented upon return from the subject. Used containers will not be stored in the pharmacy. If the sponsor is unwilling to approve destruction of investigational drugs returned by subjects prior to monitor review, a waiver must be requested. An additional fee will be incurred for storage of subject-returned medication bottles. Complete records are maintained for all drugs returned or destroyed as a part of the perpetual inventory system.
• All pharmaceuticals are designated as hazardous waste and are destroyed as such in conjunction with the services of Environmental Health and Safety Department.
• Hazardous waste is collected in the Fred Hutch Pharmacy accumulation area in specific containers. Full containers are sealed and stored on site in the Hazardous Waste Room, a holding area in the shipping and receiving area of the building. Fred Hutch contracts with Kleen Environmental Technologies, Inc. to transport the hazardous wastes for incineration at Clean Harbors Environmental Services in Aragonite, Utah and Kimball, Nebraska.
• Used pharmaceutical vials containing trace to less than 2% residual volume and waste designated as biohazardous are collected by Waste Management of Seattle and transported to Wheelabrator Spokane facility in Spokane, Washington for incineration.

Temperature Monitoring & Documentation, Calibration

• All refrigerators, freezers, and room temperature storage locations are alarmed and monitored with annually calibrated temperature probes. The IDS Pharmacy will use only the institutional-based temperature monitoring system. Temperature records are stored in a central location and are not stored within specific study binders. Copies of the original temperature logs are available upon request in PDF format.
• Available storage:
  • Controlled room temperature of 20 ̊ to 25°C (68 to 77°F). Excursions between 15and 30 C (59 and 86 F) allowed as experienced in pharmacies and hospitals.
    • Controlled Room Temperature: Reportable excursions are defined as temperature deviation of >±5 ̊C from the acceptable temperature range as defined above, sustained for a contiguous time period of more than twenty-four hours.
  • Refrigeration temperature of 2° to 8°C (36 to 46°F)
  • Freezer temperature of -25° to -10° C (-13 to 14° F)
  • Freezer temperature -70°C (range –80°C to –65°C)
    • Refrigerator, Freezer, and UltraLow Freezer Temperature: Reportable excursions are defined as a temperature deviation of ±1 ̊C from the acceptable temperature ranges as defined above, sustained for a contiguous time period of 30 minutes or more.
• If there is a temperature excursion in any of the IDS storage locations, the IDS will document the extent of the excursion (maximum or minimum temperature reached) and the duration that products were exposed to out-of-range temperatures. Investigators and sponsors will be notified of temperature excursions.
• The IDS will follow sponsor guidance regarding disposition of the investigational product.
• Investigational product which has experienced a temperature excursion will be quarantined until written approval for use is received from the sponsor.
• The IDS refrigerator and freezer equipment used for the storage of investigational products are properly maintained with equipment calibration performed by Fred Hutch Facilities’ Materials.
• Management department in accordance with the Medical Equipment Management Plan. Service records are available upon request for needed date range needed and departments specified.
• Refrigerators, freezers, and room temperature storage locations are accessed when pharmacy staff needs to retrieve IP or when a shipment is placed in associated storage location.
• All refrigerators and freezers are connected to an auxiliary power source which will be activated if there is a power outage at the institution.
• If a refrigerator or freezer is not able to maintain USP temperatures all medications stored in that unit will be removed to an alternate unit. This alternate unit will be monitored, and temperatures will be recorded for the duration of the period that IDS medications are stored.

University of Washington IDS may be involved in studies with patients receiving treatment at UWMC. To streamline services for oncology trials, both Fred Hutch and UW IDS pharmacies share a single SOP and both utilize Vestigo®. 

UWMC IP shipping address:
Investigational Drug Services
University of Washington Medical Center - Montlake
Room EA-151-J1, Pharmacy Services
1959 NE Pacific St
Seattle, WA 98195

Laboratories

Clinical Accreditations & Licenses

Fred Hutch is a National Cancer Institute (NCI)-designated Cancer Center that is accredited by The Joint Commission, the Commission on Cancer, and several other agencies. Our commitment to quality and safety has earned us The Joint Commission’s Gold Seal of Approval, an accreditation that serves as the gold standard of health care in the U.S. and the global community.

Accreditations and licenses are held with the following national agencies: 

• American College of Radiology
• American Society for Histocompatibility and Immunogenetics
• College of American Pathologists
• Commission on Cancer
• Foundation for the Accreditation of Cellular Therapy
• The Joint Commission

Fred Hutch holds the following additional certificates issued by regulatory and accreditation bodies: 

• Certified Mammography Facility from the Department of Health and Human Services/U.S. Food & Drug Administration
• Accreditation for DMEPOS by the Board of Certification/Accreditation International
• Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue-Based
• Products from the Food and Drug Administration

Fred Hutch holds these additional licenses from state regulatory bodies:

• Washington State Department of Health
  • Acute Care Hospital License
  • Fred Hutch Employee Health and Safety Clinic Medical Test Site Certificate of Waiver License

To see all clinical lab-related licenses, accreditations and certificates please visit the clinical labs page.

Access our publicly reported quality measures. 

Review The Joint Commission’s Quality Report about Fred Hutch [formerly SCCA]. 

The Alliance Lab (Fred Hutch Clinical Laboratories)

The Alliance Lab, with main and satellite labs located on Fred Hutch SLU (South Lake Union), Evergreen, and Peninsula campuses, provide phlebotomy (SLU only), sample processing, and clinical laboratory diagnostics. The Alliance Lab is the distribution center for samples with requests for diagnostic tests performed at other laboratory facilities. Certifications and Accreditations: College of American Pathologists (CAP), Clinical Laboratory Improvement Amendments (CLIA). 

Alliance Lab (Blood Draw) hours:
Weekdays, 6:00 a.m.–6:00 p.m. (last appt 5:45 p.m.) | Weekends and holidays, 8:00 a.m.–4:30 p.m. (last appt 4:15 p.m.) 

Alliance Lab (Specimen Processing) hours:
Weekdays, 6:00 a.m.–10:00 p.m. | Weekends and holidays, 7:30 a.m.–6:00 p.m. 

Alliance Lab (Testing) hours: 
Weekdays, 6:00 a.m.–10:00 p.m. | Weekends and holidays, 8:00 a.m.–6:00 p.m.

• Processing counter & hood
• Refrigerated and room temperature centrifuges to process 3-10 mL blood tubes (not 10-50 mL conical tubes)
• Vortex, water bath, pipettors
• Wet/dry ice
• Temperature is alarmed and continuously monitored with calibrated temperature probes. Alarm notifies designated personnel 24-hours per day, with backup available in the case of power outage. Date-specific temperature tracking records are available upon request.
• Annual preventative maintenance and settings confirmation are performed on schedule by Medical Equipment, temperatures are recorded daily and monitored continuously.

The Alliance Lab also performs:

• Hematology tests including complete blood count (CBC) and differentials
• Chemistry tests including electrolytes, proteins, and enzymes
• Coagulation tests
• Urinalysis
• Blood gas analysis

Pathology

Research Pathology Laboratories are a shared resource to provide the Consortium members with comprehensive support, including: collecting and fixing fresh tumor biopsies, cutting and staining of slides, tumor content confirmation for archival blocks or slides, and shipment and storage of biological samples. 

Fred Hutch utilizes several different pathology services from the below labs:

• More information about Experimental Histopathology services
• More information about Specialized Pathology services
• More information about Antibody Technology services
• More information about Northwest Biotrust services

Clinical Research Specimen Processing (CRSP) 

CRSP is a Shared Resource at Fred Hutchinson Cancer Center.

Locations & Lab Hours:
Main Lab: 1208 Eastlake Building, Room T1-101 
Weekdays, 7:00 a.m.–9:00 p.m. (closed weekends)
Last samples must be in the lab by 9:00 p.m. 

Satellite Lab: 6th Floor of Fred Hutch SLU Clinic, Building 1, Room G6-091
Weekdays, 7:00 a.m.–3:00 p.m. (closed weekends)
Last samples must be in the lab by 3:00 p.m.

• CRSP requires the Laboratory Instruction Manual and materials for the specimen processing portion of Clinical Trials.
• Monitor visits to view laboratory, equipment, and maintenance logs are to be scheduled in advance.
• The Laboratory’s Standard Operating Procedures (SOPs) available upon request.
• Freezers have SmartSense temperature monitoring system and are hard wired to facility alarm systems.
• Ambient and refrigerated centrifuges
• Micro centrifuge
• Specimen storage available at
  • Ambient
  • 4° (refrigerator)
  • -20° (mechanical freezer)
  • -80° (mechanical freezer)
  • Liquid nitrogen (vapor phase) freezer
• Bio-safety cabinets (laminar flow hood)
• Step gradient processing for peripheral blood mononuclear cells (PBMC)
• Guava automated cell counters with cell viability
• Sample login kiosk HutchBase LIMS system. A networked computer system provides access to a system operated to support population-based studies which is used for case ascertainment, data entry, and database management.

Services: 

• Specimen types include whole blood, bone marrow aspirate, urine, stool, bodily fluids, etc.
• Timely processing of specimens as per study lab manuals including
  • Temperature controlled centrifugation and aliquoting
  • Step gradient processing of whole blood or bone marrow (Ficoll, buffy coat, peripheral blood mononuclear cells (PBMC))
  • Cell counts that include cell viabilities
• Tracking (data entry) of all specimens and derivative aliquots
• Temporary specimen storage 
• Shipping to central labs / collaborators

Specimen Storage

CRSP offers temporary storage of clinical research specimens. All temperature-controlled storage is under controlled access and monitored 24 hours a day, 7 days a week by the Engineering Department, with annual freezer validation performed by Precision Mechanical.

Storage is available on a per box basis with appropriate inventory tracking at the 'box' level. Storage containers hold 2 ml vials and 5 ml vials. Storage fees are per box on a monthly basis. Advance notice is requested for specimen retrieval.

Infusion

Infusion Capacities & Hours:
Infusion: 41 bays, including 2 negative pressure rooms
Weekdays, 7:00 a.m.–10:00 p.m. | Weekends and holidays, 8:00 a.m.–6:00 p.m.
Infusion—short stay unit: 10 bays
Weekdays, 8:30 a.m.–6:30 p.m. | Weekends and holidays, closed
Clinical Trials Unit (CTU): 13 bays
Weekdays, 8:00 a.m.–10:00 p.m. | Weekends and holidays, closed

Equipment & Administration Supplies

• Use of Fred Hutch infusion pumps is required. Sponsor-provided infusion pumps will not be accepted.
• A Spiros cap is required for hazardous drug infusions. IDS Pharmacy determines hazardous status for investigational products based on the Safety Data Sheet (SDS) and Investigator’s Brochure (IB) information.
• Needles used by nurses for drug administration must have sharps safety features.
• Infusion/CTU uses the GE MAC 5500HD ECG machine, which uses the Bazett formula (QTcB) to calculate QTc. This ECG machine does not auto calculate the Fredericia formula (QTcF).

ECG

• 12 lead ECG machines are readily available on site.
• The GE MAC 5500HD ECG machine ECG report includes HR, PR, QRS, QT/QTc, PT axes and BP. This machine uses the Bazett formula (QTcB) to calculate QTc. This ECG machine does not auto calculate the Fredericia formula (QTcF).
• RR interval can be done by the investigator regardless of automatic calculation by the machine, there is no other/separate measurement of RR.
• There is enough availability of ECG machines for collection of ECGs prior to PK blood draws.
• Cardiologists are available for ECG consultation, if required.
• ECHO/MUGA equipment for the evaluation of LVEFs is available.
• Site has the ability to utilize sponsor-provided ECG machines.

Pumps

• Plum 360
• CADD pump – EPOCH and Blincyto
• Dosi-fuser – 5FU
• Medfusion 3500 – syringe pump
• All tubing is made of PVC (polyvinyl chloride), DEHP-free, and latex-free

Imaging / Molecular Imaging 

Site is able to readily provide images to the sponsor, if needed. 

Site is able to provide scanned-in original DICOM format via disc or file upload to a Blinded Independent Radiology Review Committee (BIRC) within 5 business days of subject’s image assessment visit. 

Site Imaging Capabilities

• Ultrasound
• Magnetic Resonance Imaging (MRI)
• PET/CT
• PET/MR
• SPECT/CT
• CT
• DEXA
• XRay
• Nuclear Medicine imaging and therapy
• Imaging-guided drug administration

Site Imaging Equipment

Vevo 2100 Ultrasound

Our Vevo 2100 ultrasound is equipped with two transducers that send ultrasonic waves through the imaging sample and detect reverberations, which are compiled to form an image. This is used for applications including imaging, early monitoring of tumor growth, image-guided injections for minimally invasive orthotopic tumor models and targeted therapy. Three dimensional-mode imaging for anatomical and vascular visualization, when combined with either B mode, power Doppler, or nonlinear contrast imaging, allows for quantification of volume and vascularity within a defined anatomical structure.

• Spatial resolution limit: ~ 30 μm – 10 mm
• Image acquisition time: milliseconds – seconds
• Transducers: MX250S, MX550S
• Analysis software: Vevo lab

MRI Information

EchoMRI

The Echo takes direct measurements of total body fat, lean mass, free water and total body water masses in subjects up to 100 grams. The instrument is easily operated, and scanning takes 0.5 – 3.2 minutes, depending on the precision options.

Acquisition of body composition measurements does not require anesthesia or special preparation. Numeric results are stored and can be viewed again later at any time, for regular and repeated measurements without side effects, radiation or toxicity issues.

• Analysis software: Microsoft Excel

Radiology Camera Specs

UW OncoRad/ Tumor Imaging Metrics Core (TIMC)

The OncoRad Tumor Imaging Metrics Core is a highly skilled team of radiologists and research scientists. They provide criteria-based (e.g. RECIST1.1) radiologic assessment of treatment response for cancer patients and partner with oncologists to guide treatment decisions and to improve patient outcomes.

Procedure Suite, Radiology, Etc

Interventional Radiology & Procedure Suite

• Fred Hutch venue for invasive procedures with or without moderate sedation, and with or without general anesthesia.
• On average, the Procedure Suite sees 30-35 patients per day.
• There are 6 procedure rooms and 2 interventional radiology rooms, Respiratory isolation can occur in prep/recovery and procedure rooms including all types of isolation except for negative airflow for respiratory.
• Heart rate (HR), blood pressure (BP), respiratory rate (RR), oxygen saturation (O2sat), temperature, and End-Tidal Carbon Dioxide (EtCO2) related to sedation monitoring, pain, & sedation level measurements are recorded as standard in the EMR for vitals.
• Local, minimal, moderate (conscious), or general anesthesia can be administered according to the procedure order.
• The Procedure Suite has two medication refrigerators, as well as ice available for research sample storage and transport – wet ice only, no dry ice available.

Procedures

• Bone marrow biopsy, aspiration and skin biopsy, performed by procedure suite Bone Marrow RN or Advanced Practice Provider (APP)
• Gastroenterology procedures including esophagogastroduodenoscopy, colonoscopy, sigmoidoscopy, esophageal dilation, endoscopic ultrasound and biopsies, anoscopies.
• Pulmonary procedures, including bronchoscopy, bronchioalveolar lavage, transbronchial biopsy, endobronchial ultrasound, electromagnetic navigation bronchoscopy and thoracentesis.
• Lumbar puncture with or without intrathecal methotrexate
• Placement and removal of tunneled and non-tunneled central vascular access devices
• Image guided percutaneous biopsies utilizing CT, US or fluoroscopy. Radionuclide mapping of liver tumors prior to treatment (aka Y-90 mapping).
• Administration of procedural sedation or anesthesia.
• Provide support for clinic emergency response as members of medical emergency response team.

Apheresis 

The Apheresis Unit (APH) is an FDA-registered, Foundation for the Accreditation of Cellular Therapy (FACT)-accredited apheresis collection center providing services for adult patients at Fred Hutch [South Lake Union (SLU) campus] and adult mobile services at Fred Hutch at UW Medical Center - Montlake Hospital. 

Capacities & Hours:

• SLU Clinic Collections: 7 bays, including 1 respiratory isolation room but without negative pressure
• Inpatient Montlake Hospital Collections: 1 mobile unit available

Weekdays, 7:00 a.m.–5:30 p.m. l Weekends and Holidays, 7:00 a.m.–5:30 p.m. on call
Collection Start Times: 7:30 a.m., 11:00 a.m. (if same-day central line placement is required), or 1:00 p.m.
After hours coverage for emergent therapeutic procedures available

Collection Unit

• APH is the procedural unit for specific white blood cell procedures including Hematopoietic Progenitor Cell (HPC) and Mononuclear Cell (MNC) collections for autologous, allogeneic, syngeneic, immunotherapy, gene therapy, and research donors, and performs buffy coat enrichments (BMP) on bone marrow harvests. Other therapeutic procedures provided as needed include extracorporeal photopheresis (ECP), therapeutic plasma exchange (TPE), therapeutic cell depletions for both white blood cells (WBCD) and platelets (PLTD), and red cell exchange (RCE).
• As a part of FACT accreditation, APH utilizes a quality plan in collaboration with and as a part of the Cellular Therapeutics Program (CTP). CTP consists of CTP Quality Assurance, APH, Cellular Therapy Services, and the Cellular Therapy Laboratory. Regulatory, quality support, and materials management are provided by both internal and external resources.
• All procedures require high volume, steady blood flow rates. A high flow Central Venous Access Device (CVAD) or peripheral veins may be used. All donors/patients must attend a pre-Apheresis patient orientation, education, and screening appointment performed by APH RNs. If a patient/donor is deemed to have inadequate veins during patient orientation/screening, a CVAD is required.
• All collections must have 2 large bore access points. Peripheral IV or CVAD can be one of the following: 
  • Double lumen, high flow tunneled central line (such as a Hickman or Glidepath), with preference for 13.5F or larger
  • Double lumen, high flow non-tunneled central line (such as Mahurkar), also with preference for 13.5F or larger
• The amount of blood to be processed on the machine must be defined and cannot be a range. A standard collection volume is 12L of whole blood processed and procedures last no longer than 6 hours. Use of pre-collection patient laboratory values to determine collection volume is available if done within 24 hours of scheduled collection. APH performs collection efficiencies, which regularly exceed current industry standards.
• Use of Heparin + ACD-A as an anticoagulant is standard; ACD-A only is utilized on a case-by-case basis. APH standard is to add 100mL of autologous plasma and 40mL of ACD-A + heparin to the product bag at the beginning of the procedure.
• Standard treatment plan for the collection of MNCs and HPCs is to perform a custom blood prime using donated allogeneic packed red blood cells for patients meeting low blood volume thresholds.
• Procedures for aseptic technique are followed and a functionally closed, single use, sterile kit for blood product collection is used.
• Heart rate, blood pressure, respiratory rate, and temperature are recorded within procedural flowsheets. Oxygen saturation can be added. Medical oversight is always available.
• APH follows ISBT 128 requirements for labeling for product collections along with institutional identification standards.
• If required, bariatric resources are available.
• APH does not have a refrigerator to store collected blood products. There is temperature & humidity monitoring throughout the procedural areas as well as within the processing and storage rooms.
• APH does not package or ship products and does not have the space to store study-specific supplies or shippers.

Study Start-up

The study start-up process may be facilitated by the Central Startup Team or directly by the study team. To activate an oncology trial, the study may undergo the following: Research Group Review, Scientific Review Committee, ancillary regulatory reviews, IRB approval, Budget finalization, CTA execution, and clinic implementation.

Research Group Review

Cancer-related interventional research is reviewed by the relevant disease and modality Research Groups to ensure prioritization of trials for relevant patient populations and to reduce the number of studies that are low-accruing due to competing trials.

Research Group review serves as the first stage of the Consortium Protocol Review and Monitoring System (PRMS) and is scheduled directly with the groups themselves.

Initial interest in implementing a concept or protocol should be obtained prior to structured intake. Formal Research Group Review and completion of the Research Group Review form are not required until before submission to the Scientific Review Committee.

Structured Intake

All components of structured intake must be complete prior to initiation of startup activities by the Central Startup Team or study team.

• Sponsor confirmation of site selection.
• Pre-approval of Oncology Standard Fee Letter (for industry-funded studies).
• Collection of minimum required documents, approvals, and preliminary questions related to regulatory and clinic implementation requirements. 

Minimum Required Documents

• Final Protocol
• Informed Consent Form (ICF) Template(s)
• Sponsor Budget Template
• Sponsor Contract Template
• Pharmacy Manual(s) - draft acceptable
• Investigator’s Brochure(s) or Device Manual(s) - draft acceptable
• Imaging Manual - draft acceptable
• Product Manual(s)
• Lab Manual - draft acceptable
• Oncology Standard Fee Letter Approval (for industry-funded studies)
• Sponsor approval of Fred Hutch/UWMC Closed System Transfer Device (for non-oral investigational products)
• Sponsor acknowledgement of Fred Hutch/UWMC IDS SOP
• Safety Data Sheet

Start-up Processes & Dependencies

Timing and Communication Expectations

• After completion of structured intake, the projected timeline for startup activities facilitated by the central startup team is 100 days from the time of startup assignment to site activation.
• To meet the projected startup timeline, budget and contract negotiations must be succinct.
• Sponsor and/or affiliated Clinical research Organization (CRO) partnership is required to increase trial opportunities for patients and maximize scientific impact.
• Expeditious response is needed at each step of the startup process (i.e., regulatory, clinic implementation, budget, contract negotiation, etc.).

Scientific Review Committee

All cancer-related interventional research must receive scientific review as mandated by NCI.

Scientific Review Committee approval is required after Research Group review, but prior to IRB review.

• The Scientific Review Committee (SRC) is the second stage of the Consortium Protocol Review and Monitoring System (PRMS).
• Expertise represented in the SRC includes laboratory science, clinical trial design and conduct, biostatistics, oncology, and prevention, cancer control and population-based science specialties.
• Elements of SRC review:
  • Scientific merit and interest
  • Potential clinical significance
  • Study design
  • Fit of eligibility criteria with the profile of Consortium patients
  • Value added by participation of Consortium investigators
  • Fit of the trial within the context of other open trials
  • Anticipated accrual and feasibility
  • Potential for enrollment of women, minorities, and individuals across the lifespan

SRC Timing

• The SRC meets weekly.
• All required submission documents must be submitted by the submission cut-off date of the corresponding meeting.
• The median time from submission to approval for industry studies is 2 weeks.

Budget

• Upon completion of structured intake, the protocol and study documents are utilized to create detailed study calendars in the CTMS, reflecting the specific events and procedures which occur in the conduct of the study.
• A coverage analysis is then performed, ensuring that all events and procedures in the CTMS have an assigned coverage type, in compliance with the Medicare National Coverage Determination 310.1 and relevant national and local coverage requirements.
• The study budget is then developed, capturing the anticipated costs for the research events and procedures identified in the coverage analysis. Sponsor budget templates are updated, reflecting the costs in conducting the study.
• Budget negotiation should be finalized prior to scheduling a site initiation visit.

Contract

• CRS Industry Clinical Contracts Office (ICCO) or UW Office of Sponsored Programs (OSP) negotiates and facilitates execution of agreements for Cancer Consortium clinical trials.
• Budget & contract negotiations should be completed prior to the site initiation visit.
• Fred Hutch and UW are both registered as Accelerated Clinical Trial Agreement (ACTA) institutions (https://ara4us.org/). When Sponsors agree to use the ACTA template, it significantly expedites contract negotiations.

Timing

• ICCO or OSP negotiates contract terms with Sponsor and sends final contract to Study Team for confirmation of the budget exhibit and to obtain the PI’s signature.
• ICCO or OSP signs the contract on behalf of Fred Hutch or UW, respectively.
• ICCO or OSP send the partially executed contract to the Sponsor for signature.
• Once the clinical trial agreement is fully executed, ICCO or OSP send the fully executed contract to the Study Team for their records.

Site Initiation Visit (SIV) Overview

• Once budget and contract are finalized, Scientific Review Committee and IRB approval is received, SIV is scheduled for study activation.
• The following staff will be available at the SIV as needed: PI, Research Manager, Study Coordinators, Regulatory Specialist, IDS Pharmacy representative(s), and representatives from other applicable clinical and research service areas.
• Training logs will be signed at the SIV or sent out electronically afterward.
• Remote SIVs are recommended.
• SIV is typically scheduled 2-6 weeks out, depending on staff availability.

Monitoring

Remote Monitoring

External monitors will request access to Epic & ORCA using Research Access to Patient Data (RAPiD), a REDCap-based portal. 

• Study teams will provide external monitors with the RG Number for their study, as this is a required field on the RAPiD access request form. 
• Monitors must:
  • Provide a unique identifier (driver's license, employee ID, or passport number)
  • Complete an EHR attestation
  • Request access 10 days in advance, if possible
• After an external monitor requests access, UW Research IT will validate access. Then the study team will receive an email to release patients. Emails to external monitors and study teams will include job aids. Job aid for monitors "Requesting External Monitor Access" is available on the landing page of the RAPiD portal. 
• Monitors will have access to the LK Archives via EpicCare (EC). More information for access to be provided upon request.

FDA Inspections 

Fred Hutch has hosted numerous successful FDA Bioresearch Monitoring inspections of Clinical Investigators in association with commercial marketing applications. Resources include: 

• Online FDA inspection training modules for investigators and staff
• Guidelines and SOPs for inspection preparation, conduct, and follow-up
• Experienced regulatory affairs support throughout the inspection process

Electronic Medical Records (EMR)

Name & Version: Epic Hyperspace November 2023, validated. 
Owned by University of Washington Medicine 

Security

• All users have their own unique User ID and Password, which are required to be changed periodically. Multiple failed log-in attempts will lock the account.
• Log-in credentials may NOT be shared between individuals.
• Accounts will automatically be logged out after an idle period.
• External study monitor accounts will have read-only access to assigned study participant records.
• System is backed up daily with contingency plan in case of system failure or disaster.

Record Integrity 

• Previous data can be changed by the original data creator or another user, however these are recorded by a computer-generated audit trail that records user entries and the time and date of change
• Other individuals may record data on behalf of an investigator. In these cases, data are always reviewed and/or validated by the investigator, which is recorded in the system.
• A secure, computer-generated audit trail automatically records entries that create, modify, or delete data in the medical record. This is available for view in a readable format and retained per record storage requirements.
• Audit trail shows:
• Who made the change
• Time/date of change
• Reason for change if entered
• Previously recorded data
• Patient information originally recorded in the EMR is retained per institutional standards. 

Training and Use 

• Training is required, and documented training can be provided upon request
• SOPs/guidance documents exist for the use, operations, and maintenance of Epic, and may be provided for review upon request

Content

• Fred Hutch uses both electronic medical records (EMR) and traditional paper method for source documentation. Records may include scanned documents recorded originally on paper - in these cases, the original documents are usually shredded or otherwise destroyed.

EMR Checklist

• EMR Checklist