The key decisions involved with the pre-study preparation of investigator-initiated clinical research includes the following:
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
UW DEPARTMENT OF PATHOLOGY NWBIOSPECIMEN
UW DEPARTMENT OF RADIOLOGY RESEARCH PROGRAM
ITHS RESEARCH COORDINATION CENTER FOR RESEARCH STAFFING
If you will use the UW’s electronic medical record systems (ORCA and Epic) to identify eligible patients or capture clinical data about participants, you’ll 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: firstname.lastname@example.org.
If you access PHI for research purposes under an IRB-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, email@example.com
Accounting of Disclosures
Use & Disclosure of Protected Health Information for Research
Accounting of Disclosures of Protected Health Information
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 IRB approval of a Waiver of HIPAA Authorization (and if the UW is the IRB 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.
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.
If results of testing performed by UW Lab Medicine will be part of data capture, you must maintain copies of lab normal ranges along with CLIA and CAP certifications.
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.
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.
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 Institutional Review Board as part of the research activities. You may need to work with your department to identify specific procedures for compensation of research participants.
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.
Certain types of interventional clinical research studies are required to be listed on ClinicalTrials.gov, but all researchers may post their study to ClinicalTrials.gov (even observational studies).
You are required to post your study to ClinicalTrials.gov if you are conducting:
In addition to these requirements, your funding agency (National Institutes of Health) or certain journals (ICMJE) have standards for posting certain studies on Clinicaltrials.gov.
Required studies must post study results on the site within a year after study completion. Failure to register with ClinicalTrials.gov may result in fines from National Institutes of Health or Food and Drug Administration, and may prevent study publication. Please see the NIH Grants & Funding website for more information about this requirement.
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.
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.
Assistance for setting up a study binder can be secured from:
Many researchers set up custom study databases to centralize data entry optimized for analysis. You might choose to use Microsoft Excel, Microsoft Access, or ITHS REDCap.
REDCap features a high degree of customizability for your forms and advanced user right control. It also features free, unlimited survey functionality, a sophisticated export module with support for all the popular statistical programs, and supports HIPAA compliance. Researchers use REDCap for a variety of different purposes, including:
To make sure you are prepared to conduct the trial, do a walk-through of the research procedures before you schedule the first visit:
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 | firstname.lastname@example.org
Training in the Protection of Human Research Subjects
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).
University of Washington 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.
For studies 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.
EPIC REVENUE CYCLE OPERATIONS EDUCATION
email@example.com | UW Medicine Account Activation Request Form
Register for Epic classroom training course, RES110: Epic Research Participant Enrollment
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.
Members of your research team may need to complete radiation safety training or review “Radiation Safety Training for Ancillary Personnel.”
If your research team will package and ship specimens via land, air, or sea, then 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.
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.