In compliance with federal regulation and OHSU institutional policy, all investigators, research staff, and other relevant personnel must complete Collaborative Institutional Training Initiative (CITI) trainings.  See the CITI Program webpage to determine which of the following CITI courses you are required to complete: 

• Responsible Conduct of Research (RCR)
• Human Subjects Research (HSR)
• Good Clinical Practice

The OHSU Institutional Review Board (IRB) has online training materials and offers a monthly IRB Lunch and Learn (register in Compass).  Previous IRB Lunch and Learn recordings can be found in the Education Archive on the OHSU Integrity IRB Education and Event O2 page.  

IRB 101 Training Modules

• Intro to IRB (Getting Started)
• Intro to IRB (Overview)
• Intro to IRB (non-OHSU Collaborators)

eCRIS (electronic Clinical Research Information System) is the OHSU clinical trials management system used for administrative management of clinical research studies.  The eCRIS webpage includes the user manual, flow chart, and login information.

Contact ecrissupport@ohsu.edu to request initial training, refresher training, and ongoing questions/support.  

Research Administration Training and Education (RATE) offers research administration training courses, opportunities to share resources, and networking with other research administrators and those who work in support of the research mission. Recommended RATE courses for clinical research workforce include: 

• RDA 101
• Clinical Trials 1: Budgeting, Coverage Analysis, and Account Set Up
• Clinical Trials 2: Post Award

Sign up for the Research Administration Information Network (RAIN) to receive invites to monthly meetings and to stay up to date.  

The Epic for Research SharePoint site has links to tip sheets, tools, and polices for the use of Epic for research.  The following trainings are available in Compass:

• Epic Training for Research Staff (virtual – register in Compass)
• Epic Training Pre-work: EpicCare for Research Staff
• Research Billing Review Activity (online class in Compass)

BioRAFT provides web-based training to workforce personnel based on their current job activities and hazards.

The OCTRI Clinical and Translational Research Center (CTRC) offers an in person phlebotomy course for research staff.  

Use the Phlebotomy Training Registration Form to sign up for the next available classes. 

National Institutes of Health (NIH) training opportunities:

• DIAMOND is a collaborative source of training resources for clinical and translational research professionals
• NIH Office of Clinical Research Education and Collaboration Outreach Clinical Research Education

U.S. Food and Drug Administration (FDA) training opportunities:

• FDA Training and Continuing Education
• FDA 101: An Overview of FDA’s Regulatory and Research Activities 
• FDA Education and Resources by Subject 

U.S. Department of Health and Human Service (HHS) training opportunities:

• OHRP Webinars on 45 CFR 46

All studies that meet the ICMJE definition of a clinical trial must be registered with ClinicalTrials.gov prior to the first patient enrolled to preserve your ability to publish the study results. NIH and FDA also require registration and results posting of applicable clinical trials. 

In addition to registration prior to first patient enrollment, there are ongoing maintenance requirements.  Any failure to maintain the registration can jeopardize publication, current and future study funding, contractual obligations, and may incur significant fines.

Review OHSU and federal resources below.

• Clinicaltrials.gov training materials
• Videos regarding expectations for FDA regulated applicable clinical trials:
  • ClinicalTrials.gov: Part 1 - Meeting Transparency and Reporting Requirements (12:17) 
  • ClinicalTrials.gov: Part 2 - Definitions, Laws, and Regulations (15:32) 
  • ClinicalTrials.gov: Part 3 - CDER’s Compliance and Enforcement Activities (16:32) 
• OHSU CRSO Clinicaltrials.gov page for OHSU policies and contact information for assistance  
• OCTRI Research Forum past presentations covering registration, maintenance, reporting, and common problems available (open accordion and drop down to Clinicaltrials.gov presentations). 

Clinical Research United (CRU) is a place to connect with others doing clinical research at OHSU.

CRU has a Teams channel where you can post questions and share information.

CRU hosts a monthly, informal Clinical Research Coordinator Coffee Chat for clinical research coordinators and staff to share experiences, discuss best practices, and connect with others doing similar work.

Coffee Chats are every third Tuesday at noon via WebEx. Find details on the O2 calendar by searching "Coffee Chat".

Questions? Email Kitt Swartz.

The Career and Workplace Enhancement Center (CWE) provides professional development resources. Offerings include anti-racism, conflict coaching, digital literacy courses, and many more topics.  

CWE also offers free courses through LinkedIn Learning. 
 

Registration for the Fall 2023 SOCRA exam is now closed.

OCTRI will be hosting the SOCRA exam again in Fall 2024. Date TBD. Information to help you prepare for the next exam is available below.

• SOCRA certification eligibility requirements 
• SOCRA application information
• OCTRI SOCRA Exam Prep Slides