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Pre-Study Preparation

Pre-Study Preparation

The key decisions involved with the pre-study preparation of industry-sponsored clinical trials include the following:

Confirm Research Support Services/Facilities

Confirm Research Support Services/Facilities

Based on your final budget and contract, contact the supporting departments who will be involved with the trial to let them know you are ready to begin. This might include:

ITHS CLINICAL RESEARCH CENTER

ITHS RESEARCH COORDINATION CENTER

INVESTIGATIONAL DRUG SERVICE PHARMACY
Harborview Medical Center
(206) 744-5448 | hmcids@u.washington.edu
UW Medical Center
(206) 598-6054 | uwmcids@u.washington.edu
Website

UWMC LABORATORY MEDICINE
Administration
(206) 598-6131 | 
lmofficesupport@uw.edu

RESEARCH TESTING SERVICE
(206) 616-8979 | rts@uw.edu

UW DEPARTMENT OF PATHOLOGY NWBioSpecimen

UW DEPARTMENT OF RADIOLOGY RESEARCH PROGRAM

Site Initiation Visit

Site Initiation Visit

Many industry sponsors/Clinical Research Organizations conduct a Site Initiation Visit (SIV) to prepare and set up a research site, conduct protocol training, and ensure the Principal Investigator (PI) fully understands all trial responsibilities.  The visit usually occurs after the site has completed all regulatory requirements, including Institutional Review Board approval, but prior to recruiting participants.  The sponsor/Clinical Research Organization will want to meet with the PI and as many members of the research team as possible.  The sponsor/Clinical Research Organization may ask to meet with representatives from supporting departments (e.g., pharmacy, radiology, lab medicine).

Topics of discussion during the site initiation visit include:

  • PI responsibilities
  • PI and research team qualifications
  • Study objectives, eligibility criteria, recruitment, and procedures
  • Space requirements, availability of a secure area to store investigational drug or devices, availability of required equipment
  • Lab manual, specimen processing, and shipping
  • Regulations and Good Clinical Practice (GCP) guidelines, informed consent requirements, Institutional Review Board obligations, adverse event reporting, drug accountability, source documentation, and records retention (regulatory documents and study file organization)
  • Data forms review (Case Report Forms, or CRFs), including electronic data entry

If it is a large multi-site trial, a sponsor/Clinical Research Organization may choose to hold an Investigator Meeting in lieu of conducting site initiation visits.  In this case, the meeting is held sometime after the Site Qualification Visit (link to Site Qualification Visit) and prior to recruiting participants. The Investigator Meeting is usually only attended by the PI.  However, if the PI is unable to attend, the sponsor/Clinical Research Organization may allow a co-investigator or research coordinator to attend.  Travel to this meeting is coordinated and paid for by the sponsor/Clinical Research Organization.

Access to UW Electronic Medical Records

Access to UW Electronic Medical Records

To use the University of Washington’s electronic medical record systems (ORCA and Epic) to identify eligible patients or capture clinical data about participants, you will need to request ORCA and Epic access for necessary research staff from User Access Administration.

If you have questions about ORCA access privileges or how to complete the form, contact: uaa@uw.edu.

If you access PHI for research purposes under an Institutional Review Board-approved HIPAA waiver, you must record and submit records of the dates and purposes of these disclosures to UW Medicine Compliance via the UW Medicine Disclosure Accounting online database.

UW MEDICINE COMPLIANCE
(206) 543-3098 | comply@uw.edu
Accounting of Disclosures
Use & Disclosure of Protected Health Information for Research
Accounting of Disclosures of Protected Health Information

Pre-Screening to Identify Participants

To identify possible subjects for research, you may need to access Epic or ORCA to look at healthcare records. Even if you are involved in the clinical care of the possible subjects, you will need Institutional Review Board approval of a Waiver of HIPAA Authorization (and if the UW is the Institutional Review Board reviewing the project, a Waiver of Informed Consent and Confidentiality Agreement as well).

Members of your research team may need to complete Epic Training, which is described in the “Training/Credentialing” section below.

Clinical Research Billing for Research Procedures

There are complex federal and private payer rules that govern the conditions under which clinical services, items and tests associated with a research study can be billed to study sponsors, study subjects and/or their insurers. Research teams are required to use Epic to accurately bill for research procedures. Accurate research billing depends on planning and collaboration between the research team and a wide variety of individuals and offices before, during and after the study is initiated.

EPIC REVENUE CYCLE OPERATIONS EDUCATION
ctrain@uw.edu
Research Billing Compliance Policies
Research Participant Association in Epic
Epic Billing Tools

Laboratory Medicine and Research Testing Services

Laboratory Medicine and Research Testing Services

If results of testing performed by University of Washington Lab Medicine will be part of data capture, you must maintain copies of lab normal ranges along with CLIA and CAP certifications.

Licenses & Accreditation

Lab Medicine is also the home department for Research Testing Services, which coordinates and provides research-related phlebotomy, CLIA-licensed testing, research-only testing, processing, and limited specimen storage.

UW LABORATORY MEDICINE
Research Testing Service
(206) 616‑8979 | rts@uw.edu

Research Instrument Validation and Calibration

Research Instrument Validation and Calibration

Scientific Instruments supports more than 18,000 pieces of patient care, laboratory, and research equipment spread across the greater Seattle area including UW Medical Center, Harborview Medical Center, Northwest Hospital & Medical Center, Seattle Cancer Care Alliance, UW Physician’s Neighborhood Clinics and a variety of other University, state, federal and other publicly funded agencies.  Their records can be used to document compliance with TJC, CAP, CLEA, AABB, Food and Drug Administration, CMS, or other accrediting agencies’ requirements for equipment maintenance.

UW HEALTH SCIENCES SCIENTIFIC INSTRUMENTS
Machine Shop

(206) 616-5074 | mshop@uw.edu

Arranging Compensation for Research Participants

Arranging Compensation for Research Participants

Trials often offer compensation to research participants to encourage and appreciate the time and effort involved in participation.  Payments or travel/parking reimbursements to research subjects must be approved by the IRB as part of the research activities.  You may need to work with your department to identify specific procedures for compensation of research participants.

UW HUMAN SUBJECTS DIVISION
(206) 543-0098 | hsdinfo@uw.edu

UW PROCUREMENT SERVICES
(206) 543-4500 | pcshelp@uw.edu

UW TRANSPORTATION SERVICES
206-221-3701 | ucommute@uw.edu

Register Study on Participate in Research

Register Study on Participate in Research

Researchers can post their trials to www.ParticipateInResearch.org, and potential volunteers can search for studies that apply to them. This website was developed by the Institute of Translational Health Sciences in partnership with the UW School of Medicine’s Office of Research and Graduate Education to connect research teams with members of the community.

Set Up the Study Binder

Set Up the Study Binder

Regulatory binders help research teams organize their files, maintain regulatory compliance, and adhere to Good Clinical Practice (GCP) standards for record keeping practices for research involving human subjects. Most sponsors/Clinical Research Organizations will provide the organizational forms and supplies they require you to maintain throughout the trial.

Helpful background can be found in Section 8, “Essential Documents for the Conduct of a Clinical Trial,” of the Food and Drug Administration’s guidance document E6, Good Clinical Practice: Consolidated Guidance.

Do a Walk Through

Do a Walk Through

To make sure you are prepared to conduct the trial, do a walk-through of the research procedures before you schedule the first visit:

  • Confirm pre-screening steps in Epic and ORCA
  • Create visit packets that contain your recruitment, consent, and data collection resources you will use when approaching participants
  • Role play a recruitment conversation using the recruitment script
  • Pretend to schedule a study visit
  • Role play an informed consent discussion
  • Walk from the place where you’ll meet the participant to the visit location(s)
  • Make sure you have everything you need at the visit location(s):  lab kits, MD orders, pharmacy communication, lab requisition slips, data collection forms, laptop to access eCRFs/regulatory docs, equipment calibrated and in working order, mailing/shipping containers
  • Review data collection forms (CRFs) and confirm access to electronic data entry system

Training/Credentialing

Human Subjects Protections Training

Human Subjects Protections Training

There is no institutional-wide requirement for human subjects training at the University of Washington. However, many sponsors, funding agencies, UW departments, and collaborating institutions require that all members of the research team have completed a standard training course on the protecting human subjects in research.  The Collaborative Institutional Training Initiative (CITI) web-based training meets the requirements of most industry sponsors.  To take a course on the CITI website, you must register for an account and then affiliate yourself with the UW.

UW HUMAN SUBJECTS DIVISION TRAINING
(206) 543-0098 | hsdinfo@uw.edu
Human Subjects Division website

Clinical Trial Policy Training

Clinical Trial Policy Training

University of Washington’s Clinical Research Budget & Billing (CRBB) support office provides Clinical Trial Policy Training to ensure that all UW Medicine faculty have a uniform knowledge of the regulations governing clinical research and that they understand the internal processes that have been implemented in order to maintain compliance in clinical research billing.

Your research support staff may also need to complete the CRBB modules within the UW Medicine Clinical Research Staff Training Program (CRB1, CRB2, CRB3).

HIPAA Training

HIPAA Training

UW employees who are involved with research conducted with UW Medicine facilities must complete “HIPAA Online Training” and sign the “UW Medicine Privacy, Confidentiality and Information Security Agreement” within the first 30 days of the individual’s first day as a member of the research team.

UW MEDICINE COMPLIANCE 
(206) 543-3098 | comply@uw.edu
HIPAA Privacy and Information Security Training

Epic Training

Epic Training

For trials that utilize UW Medicine clinical facilities, investigators (or their designees) are required to use Epic scheduling software to enter research subject enrollment status information and to forward study-related admission notifications to the UW Clinical Research Budget and Billing office. To do this work, members of the research team need to complete Epic training and obtain access to Epic.

Register for the Epic classroom training course, RES110: Epic Research Participant Enrollment.

EPIC REVENUE CYCLE OPERATIONS EDUCATION
ctrain@uw.edu
UW Medicine Account Activation Request Form

Bloodborne Pathogens Training

Bloodborne Pathogens Training

Principal investigators are responsible for assessing research activities to determine if members of the research team have a potential for exposure to human blood and its components, human tissue, all human cell lines, human source materials, as well as medications derived from blood (e.g., immune globulins, albumin) and other potentially infectious materials. If your research activities involve human blood and its components, you and your research team are required to comply with the UW’s Bloodborne Pathogens Program, which includes a training requirement.

UW ENVIRONMENTAL HEALTH AND SAFETY
Training Administration
(206) 543-7201 | ehstrain@uw.edu
Bloodborne Pathogens Program

Radiation Safety Training

Radiation Safety Training

Members of your research team may need to complete radiation safety training or review “Radiation Safety Training for Ancillary Personnel.”

UW ENVIRONMENTAL HEALTH AND SAFETY
Training Administration

(206) 543-7201 | ehstrain@uw.edu
Radiation Safety Training for Ancillary Personnel
Radiation Safety Training

Shipping Biohazards Certification

Shipping Biohazards Certification

If your research team will package and ship specimens via land, air, or sea, all team members must be trained and certified to ship hazardous materials. There are prescriptive requirements for packaging and labeling of hazardous materials and for the associated documentation used in the event of an emergency. There are fines for lack of certification and improper packaging and, worse, a chance for loss of life and property.

UW ENVIRONMENTAL HEALTH AND SAFETY
Training Administration

(206) 543-7201 | ehstrain@uw.edu
Shipping Hazardous Materials

UW Medical Center Credentialing

UW Medical Center Credentialing

The UW Medical Center credentialing process ensures that individuals other than physicians, Nurse Practitioners, and Physician’s Assistants who interact with patients at UW Medical Center are competent to practice in their role and have current immunizations to ensure the safety of the patients. Members of your research team interacting with UW Medical Center patients must have current credentialing.

UW MEDICAL CENTER CREDENTIALING
pcscred@uw.edu
Credentialing

Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.