Our Services

Study Coordination

Supporting Investigators and Study Teams

The Clinical Trials Office Research Coordination Center (RCC) is a multidisciplinary team of research coordinators and regulatory coordinators supporting the design and conduct of clinical trials and research studies. Our team provides expert consultation and flexible, fee-for-service coordinator staffing solutions to successfully move the studies forward.

Our study coordinators perform all PI-delegated protocol activities including:

• Recruit and screen potential study participants
• Obtain informed consent
• Schedule and coordinate participant visits
• Implement protocol-required assessments and procedures
• Complete electronic case report forms
• Collect samples and administer questionnaires
• Track adverse events (AEs), serious adverse events (SAEs) and protocol deviations
• Coordinate sponsor monitoring visits
• Support investigators with REDCap Database study submissions

Regulatory Services

Navigating the Regulatory Framework

Our Regulatory Coordinators provide expert support for both industry-sponsored and investigator-initiated clinical trials and research studies, guiding and preparing IRB, FDA and other regulatory and start-up submissions, and ensuring completeness of required documentation in compliance with Federal guidelines and regulations, applicable State laws, Institutional policies and Good Clinical Practice (GCP).

Our regulatory specialists support the PI by facilitating and coordinating protocol activities including:

• Prepare and submit IRB applications (initial, continuing review, amendments)
• Prepare and submit studies for institutional review and approvals
• Protocol development consults and guidance for investigator-initiated protocols
• Develop, draft, and edit study forms and materials
• Create and maintain regulatory binders to meet sponsor and federal regulatory requirements
• Ensure compliance with ICH GCP E6 (R2), Federal and State regulations, and Institutional policies

IND/IDE Support

Managing IND/IDE Submissions to the FDA

Our senior regulatory staff offer guidance and support to sponsor-investigators for successful submission of Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications to the FDA.

Our expert team provides qualified guidance, support, and management of FDA regulated process for IND and IDE applications, including:

• Assess readiness of study materials for submission to the FDA
• Coordinate and schedule pre-IND meetings
• Prepare and submit IND/IDE applications and reports

Research Clinic Space

Providing Clinical Support

The Clinical Trials Office’s Translational Research Unit (TRU) offers investigators and study participants the infrastructure needed to conduct clinical and translational research at UW Medicine. This support includes access to clinical research patient rooms, laboratory services, and experienced clinical staff. Located in the UW Medical Center (UWMC), the TRU allows study teams to safely conduct Phase I-III research studies with support from our trained clinical staff.

In addition, our mobile TRU (mTRU) nurses are available 24/7 to conduct research related clinical tasks at various inpatient facilities and ambulatory care settings.

The TRU provides a safe and convenient facility for investigators, study teams and patients including:

• Clinical research rooms for ambulatory and overnight visits
• Specially trained nurses and support staff
• CLIA-certified laboratory
• Office and computer space for research staff
• Consultation rooms
• State-of-the-art equipment
• Room-only use with access to emergency nursing support

Research Nursing

Providing Exceptional Research Patient Care

The Clinical Trials Office’s Translational Research Unit (TRU) is dedicated to caring for study participants and ensuring their safety while enrolled in clinical trials. We work closely with study teams to conduct protocol driven activities such as drug administrations, clinical data and sample collection.

The TRU is located at the UW Medical Center-Montlake (UWMC) and staffed by nurses and medical assistants who are GCP-certified and trained in Human Subject Protection. We provide expertise in complying with complex requirements and innovative treatments, such as immunotherapy, high-volume sampling and pharmacokinetic studies.

Clinical services administered by TRU staff for study participants include:

• Nursing care, such as frequent blood draws and IV placement
• Administration of study drugs (all routes)
• Observation and monitoring intravenous infusions
• Other clinical research tests and services (e.g., ECG, 6-minute walk test, etc.)

Study Budgeting

Developing and Maintaining Sound Financial Plans

Our experienced financial professionals work closely with Principal Investigators and Study Teams to develop, negotiate, and maintain accurate clinical research budgets in accordance with Medicare and institutional policies that are sustainable throughout the lifecycle of the trial.

Clinical trial budgeting services include:

• Coverage Analysis and Billing Grid development to facilitate clinical trial budget development and to ensure correct billing and Medicare coverage eligibility
• Financial analyses of device trials, serving as a resource to investigators on device regulations and ensuring receipt of proper device approvals
• Coding analysis of protocol procedures and provision of feasibility pricing prior to clinical trial budget development
• Development of study budgets and negotiation with study sponsors of appropriate reimbursement and payment terms
• Compliance check to ensure proper alignment of financial terms across the Billing Grid, budget, ICF language and contract terms

Trial Monitoring & QA

Assuring Quality and Accuracy

Monitoring of clinical trials ensures the protection of human subjects and the reliability of the data collection process. Several types of systematic activities are utilized in the monitoring process so that each trial is conducted according to study protocol and in compliance with Good Clinical Practice (GCP), as well as institutional policies and State and Federal regulations.

Our experienced team offers the following quality assurance services:

• Internal monitoring of both industry-sponsored and investigator-initiated trials
• External monitoring of clinical trials at other sites
• Preparation for an external audit, including FDA, sponsor, or IRB
• Verification of adherence to current protocol based on sponsor requirements and regulations
• Evaluate research participant safety and data accuracy
• Generate detailed monotoring reports and communicate findings to the Principal Investigator
• Assist in developing Standard Operating Procedures (SOPs) and Corrective and Preventative Action (CAPA) plans
• Provide dedicated training and resources to study staff