The key decisions involved with the pre-study preparation of industry-sponsored clinical trials include the following:
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:
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:
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.
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: email@example.com.
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 | firstname.lastname@example.org
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 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.
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 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.
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 IRB 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.
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.
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.
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).
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.
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.
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, 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.