Analyst Notes The OHSU Institutional Review Board website has new resources for investigators regarding the retirement of the Lay Summary and a new Minimal Risk Protocol Template. Brief Project Description Replaces Lay Summary As part of ongoing efforts to streamline submission and review processes, the IRB is replacing the six-question Lay Language Protocol Summary with a simplified Brief Project Description document. The new document contains the following instructions: Provide a brief (one page maximum) description, … Read More
Posts Tagged ‘eIRB’
IRB Update Hear details of recent and upcoming changes at the OHSU Institutional Review Board (IRB). See the new Local Context document and learn when and how to use it! Get a tour of the new Protocol Template, designed for investigator-initiated minimal risk studies – it will help you give the IRB all the information needed for your approval. Hear about other updates and get a peak of what’s coming next on Thursday, January 23, 2014 from … Read More
The date all new clinical studies enrolling prospectively consented human subjects are required to use OHSU’s electronic clinical research information system, eCRIS, has been moved to Jan. 29, 2014 from Jan. 14, 2014. We still encourage you to get prepared to use eCRIS. Some helpful ways to get prepared are: complete required and/or recommended training and visit the eCRIS information site for additional resources. Resources eCRIS website eCRIS FAQ’s Page eCRIS Training eCRIS Big Brain … Read More
What is eCRIS? 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 … Read More
OHSU’s electronic clinical research information system, eCRIS, has new functionality available. Look for the following features: Active studies with industry funding can generate invoices and display payment data from Oracle Grants Accounting (OGA). The Create Invoice button is available on the budget workspace for active studies. Invoices are created based on the information contained in the payment terms smartform. Automatic payments, or those paid to OHSU without having to create and send an invoice, can … Read More
As you may know, starting in January 2014 the electronic Clinical Research Information System (eCRIS) will be required for all studies enrolling prospectively consenting OHSU subjects. Then in July 2014, all existing studies must be migrated to eCRIS as well. We realize this change may have a significant impact on a busy study coordinator or investigator’s day, so we asked around to see how things were going. “Before the training sessions the new system seemed … Read More
Q&A: Minimal risk research Got questions about minimal risk research? We’ve got answers! Join all of the IRB Analysts for a question and answer session this Thursday, November 14, from 10-11a.m. in OHSU Hospital 8B60 Questions: Email the Research Integrity Office.
Q&A: Unanticipated problems Got questions about unanticipated problems? We’ve got answers! Join all of the IRB Analysts for a question and answer session this Thursday, October 24, from 11:30 a.m. to 12:30 p.m. in OHSU Hospital 8B60. Questions? Email the Research Integrity Office (ORIO).
From the Chair’s Desk Under HIPAA, using or disclosing Protected Health Information (PHI) for research purposes generally requires a signed authorization from the subject. There are, however, a number of exceptions to this rule. When you will not be obtaining signed authorization from subjects for a research project that is eligible for an exception, you need to complete the appropriate form or agreement to document that you have met the HIPAA requirements for the exception. … Read More
Analyst Notes Institutional Review Board (IRB) terminology can often be confusing to new and seasoned researchers alike. Here is a brief refresher on the most commonly used terms. Fully identifiable: Data or samples which include personal identifiers — information which would allow the person who provided the materials to be identified. If a study involves interaction with subjects the data or samples would be considered fully identifiable, at least when collected. Personal identifiers include, but … Read More