Preparing a New Study Submission
Prior to conducting human subject research, INVESTIGATORS NEED TO SUBMIT AN APPLICATION to the Office for Research Protections (ORP) USING THE IRB STUDY SUBMISSION PROCESS in CATS IRB. The CATS system includes an IRB "library" of templates to use for submission. Once a submission is received, IRB analysts will determine if review/approval by the Institutional Review Board (IRB) is necessary and, if so, facilitate the review by IRB member(s). In addition to completing the questions within the submission and uploading the required protocol document, investigators will need to provide all applicable supporting documents specific to their research study [i.e., informed consent forms, recruitment materials/advertisements, data collection instruments (surveys, interview outlines, focus group topics, observation sheets, etc.), grant proposal, investigator brochure, data safety and monitoring plan, etc.]. The submission process allows investigators to upload these documents within the study application.
Study Submission Guide
For investigators new to CATS IRB, the Study Submission Guide will help navigate through the electronic submission system for the development and submission of protocols, accessing study templates, training information, and other useful guidance. This guide contains step-by-step instructions for creating new studies, modifications, continuing reviews, Reportable New Information (RNI), and conversions of existing PRAMS studies. There are also checklists for what information is typically required with a submission and tips for assigning investigator roles for those who will work on the submission of research studies. To access the Study Submission Guide in CATS IRB: Log into the CATS system, click on "Help Center" (left margin), under the "Guides" tab, click on "IRB Study Submission Guide."
To assist with your study submission, please see the resources below for additional information on developing supporting documents and other important considerations as part of your CATS IRB submission.