Center for Clinical and Translational Science

To date, 32 studies have been submitted to the Advisory Committee on Clinical and Translational Science (ACCTS) and Institutional Review Board (IRB) through iRIS, and 43 studies are using the system for study and subject management. The system has three components, namely, the electronic review board assistant, study management, and subject management. The advantages of the IRB/ACCTS Submission component are that protocols are written so that they are GCP compliant and include standardized language. Annual progress reports are electronically generated, including adverse events, protocol deviations, and gender, race, and ethnicity data, saving an enormous amount of time for investigators and coordinators. Investigators’ CVs and human subjects training certificates are stored in a repository in the system so that investigators and staff who are participating in multiple studies only have to submit these documents once. Members of both the ACCTS and IRB are now reviewing protocols in iRIS, allowing them to begin their reviews as soon as the protocols are logged into the system. Investigators benefit by being able to print IRB-approved documents during or prior to subject visits.

Study management includes an electronic inclusion/exclusion checklist and a schedule of events for easy viewing by the investigator, coordinator, and nursing staff. This program also generates order sheets and worksheets. The system can also create visit time “windows” that notify the investigator when a subject does not complete a visit within the prespecified “window” dates. Adverse events logs and protocol deviation logs are stored in a convenient and searchable electronic format, ending the need to maintain paper logs.

Subject management helps the investigator track subjects’ progress during a study. Subject enrollment, randomization, and visits completed are all easily checked. Data on the number of subjects who were screened and enrolled, as well as the number who withdrew and the number who completed the study are readily available. Thus, instead of having to maintain a paper log in the regulatory binder, any authorized member of the investigation team can log into iRIS and immediately view these documents. 

If you would like to learn more about using iRIS to organize your studies, using one or more components of iRIS, or if you need coordinator, data entry, or navigation assistance, please contact Donna Brassil, MA, RN, CCRC (dbrassil@rockefeller.edu or ext -7886).