eCRIS is OHSU’s new electronic Clinical Research Information System. It is used for management of clinical research studies and facilitates study set up and ongoing management, including budgeting, financial management and subject tracking.
Is it mandatory? Starting when?
Yes. Studies that meet the inclusion criteria that are submitted to eIRB on or after 1/14/14 must use eCRIS. Ongoing studies must be transitioned to eCRIS by 7/14/14.
Which studies are required to be in eCRIS?
While eCRIS can be used to manage any human study, all studies involving prospective consent of human subjects are required to be in eCRIS. There are some exceptions:
• Chart review studies
• Studies that only involve a single visit and do not involve any potentially billable services or industry funding
• Studies only involving existing clinical samples
• Studies where no subjects are consented by OHSU faculty or employees
• Ongoing studies where all subjects have completed the active portion of the study by the required eCRIS adoption deadline and the study does not involve any more clinical services associated with the study. More on study exceptions.
Does eCRIS replace eIRB?
No. eIRB is used in the same manner as before. However, eIRB and eCRIS are integrated, and do share information. There is no duplicate entry of information between the two systems.
What training is required for investigators?
All investigators are required to take an online Big Brain course. The PI portion of the Big Brain training is tailored to investigators. After that is taken, access to eCRIS is updated overnight and granted. No further eCRIS training is required, but investigators can sign up for the study team training on Training Force if desired.
What training is required for study staff?
All study staff are required to take the online eCRIS Big Brain course, as well as an in-person 3-hour training class (sign up on Training Force - non-Knight staff or Training Force - Knight staff). Additional one-on-one training can be scheduled through eCRISSupport@ohsu.edu after the 3-hour class has been taken.
Does eCRIS replace OGA or InfoEd?
No. However, eCRIS does share information with OGA for financial tracking of industry-sponsored studies. eCRIS does not share any information with InfoEd.
Does eCRIS eliminate the need for RedCap?
No. RedCap is a different system used for management of study data. It does not share any information with eCRIS.
Who do I contact if I have questions or need more information?