Environmental Health and Safety provides information about compliance with Federal Regulations for those in direct contact with potentially infectious material (blood/tissues).
Clinical Research Coordinators (CRC) Training
The Clinical Research Coordinators Orientation and Training Program is offered twice a year: once in the spring, once in the fall. Anyone within the Consortium working in clinical research -- including Clinical Research Coordinators, Data Managers, Regulatory Coordinators and Research Nurses – is invited to attend. This series is particularly useful for those in a new role in clinical research.
Consortium Study Coordinators (CSC) Meetings
These clinical and research-oriented agendas, organized for research coordinators from the FHCRC, SCCA, and UW, are based on topics of timely import. Items of ongoing interest are brought back on a regular basis.
Meetings occur every first Tuesday of the month from 1:30 - 2:50 p.m. in Pelton Auditorium. (See our News and Events calendar for upcoming dates.)
CRS/IRO Brown Bags
Anyone interested in interacting with contacts from the CRS/IRO in a smaller setting is invited to attend these research-oriented sessions held during the lunch hour. Short presentations followed by open Q&A sessions make up the informal discussions. Agenda ideas are encouraged and welcomed!
Meetings take place every fourth Tuesday from 12 - 1 p.m. in Yale, J1-102. (You can refer to our News and Events calendar for planning.)
Good Clinical Practice
"Good Clinical Practice (GCP) are guidelines established to ensure that clinical research is consistently performed to high ethical and scientific standards.”
The Web-based GCP training courses support the Cancer Consortium’s commitment to quality, consistency and compliance in clinical research studies. Completion of the training courses helps to ensure that clinical research studies are conducted in accordance with applicable regulations. The Cancer Consortium requires GCP training for all sponsor/investigators, principal investigators, and research staff that are involved in the design, conduct, or reporting of therapeutic clinical studies and prevention studies that involve drugs, biologics, or devices.
- Collaborative Institutional Training Initiative (CITI) offers online GCP training
- Other organizations offer classroom GCP training such as the Association of Clinical Research Professional’s GCP classroom training course and the Barnett Education Services GCP classroom training course. The IRB will accept other GCP training if the course covered the same topics and written documentation can be provided.
- Mandatory Human Subjects Training
The FHCRC Institutional Review Office (IRO) website will review training requirements for research involving human subjects.
- HIPAA for Investigators and Research Staff
HIPAA Training will provide instructions for compliance with federal regulations of research participant health information.
- Investigator Guidelines
The investigator guidelines page on the FHCRC IRO extranet provides background and information specifically directed at investigators. It is a valuable resource of basic information on the IRBs function, oversight and regulations for human subjects research.
Protocol Review Coordination Training
Protocol Review Coordinators (PRCs) are available to meet with Principal Investigators (PIs) and study teams either as a group or one-on-one. Training sessions with a PRC will cover the function of Clinical Research Support (CRS), Clinical FYI and the PRC role as a liaison between the study teams and the Institutional Review Office (IRO) and the Institutional Review Board (IRB).
The PRC will share an overview of the lifecycle of a research protocol – from first contact to final approval by the IRB. Topics include document version control, forms, and the submission process for new applications, modifications, renewals, and closures. Orientation also includes how PRCs track and save work in a database for major committee reviews, for example, the Data and Safety Monitoring Committee (DSMC), the Scientific Review Committee (SRC), and IRB. Study-specific topics may be covered during the training sessions, if requested.
To schedule a training, contact CRS at 206-667-4520 or via email.
Regulatory Affairs Forum
The Regulatory Affairs Forum is an open meeting moderated by CRS Regulatory Affairs for education, discussion, and identification of challenges and solutions regarding federal regulations and guidances related to the conduct of clinical trials in human subjects. This one-hour bimonthly meeting is intended primarily for individuals who provide regulatory support to FHCRC/UW Cancer Consortium investigators, with a particular focus on investigator-initiated IND trials. All interested FHCRC, UW, SCCA, and Seattle Children’s personnel are invited to attend. Upcoming meeting dates can be found on our News and Events page.
Regulatory Affairs Online Education Series
The Regulatory Affairs Online Education Series will be held bimonthly, alternating with the Regulatory Affairs Forum, for presentation of previously recorded online presentations on pertinent federal regulations and guidances related to clinical trials. Refer to our News and Events page for calendar dates.
- Patient Safety Net (PSN) - Research Staff Training Ongoing
PSN is an anonymous online reporting system used at Seattle Cancer Care Alliance to report unsafe conditions, near misses and events that cause harm or inconvenience to patients and visitors. These slides explain how to access the PSN reporting system and describe the criteria for situations to report.
- Research Charge Capture - Research Staff Training Ongoing
The Research Charge Capture process assures accurate billing compliance for research activities. These slides were put together by the SCCA Revenue Cycle team to help new and experienced coordinators request accounts, track expenses, and submit accurate paperwork for scheduling and orders.
- SCCA Clinical Trials Policy (CTP) - Research Staff Training Ongoing
Medicare's Clinical Trial Policy (CTP) provides coverage of routine costs associated qualifying clinical trials. These slides provide education and training to help you determine if your study is qualifying and how to comply with the CTP process for Consortium study participants with billable services at the SCCA or UW Medicine.
- SCCA/UW HIPAA Training
Required for research with SCCA and UW subjects. The research module that is part of the UW HIPAA training counts for FHCRC Confidentiality Training for Investigators and Research Staff. The training provides in-depth instructions for compliance with federal regulations of research participant health information. To get access to the modules, 1) complete SCCA/UW affiliate paperwork and 2) contact User Access Administration via email at firstname.lastname@example.org.