Center for Clinical and Translational Science

The Center for Clinical and Translational Science (CCTS) utilizes the electronic Integrated Research Information System (iRIS), which offers many components that are advantageous to investigators, coordinators, other research staff, Institutional Review Board (IRB) members, and the members of Advisory Committee for Clinical and Translational Science (ACCTS). This issue highlights the advantages of recording adverse events in iRIS.

What is an adverse event?
An adverse event (AE) is any untoward medical occurrence in a research subject which may or may not have a causal relationship with the study (ICH GCP 1.2). AEs include, for example, a change in a pre-existing condition; a new onset or worsening of a symptom, syndrome, or illness; or a new significant laboratory finding. All events are required to be reported regardless of whether they are judged to be associated with participation in the study.

A serious adverse event (SAE) is one that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, or results in a congenital anomaly/birth defect. (21CFR 312.32).

All investigators are required to collect, assess, and report all AEs that occur during a study. The following information is gathered for each event: description of the AE, onset (date/time), duration, grade of severity (mild, moderate, severe, life threatening, or fatal), attribution (related, probably related, possibly related, not likely related, or not related to the study), whether the event was anticipated or not, and whether or not it is an SAE. AEs need to be reported to the IRB, sponsor, and directly to the FDA if the Principal Investigator (PI) is holding the IND (Investigation New Drug) Application. Each of these three entities has different reporting time-frame requirements. Some investigators maintain paper logs of these AEs. One great advantage of the electronic study management component of iRIS is recording of adverse events. The branching logic of the program guides you through a pathway so that all of the reporting elements are addressed. It also includes definitions in “help bubbles” for details such as attribution and grading. Once completed, if an SAE or an AE that is related to the study and greater than grade 2 is entered into iRIS, the system will automatically submit it to the IRB. If it is an AE that only requires annual reporting, it will prepopulate the iRIS Annual Progress Report Form in a tabular form.

The iRIS system is also an excellent resource to view all study AEs recorded. A running log of all AEs associated with a particular study can aid in determining if participants are experiencing a pattern or trend of specific AEs. Furthermore, if an initial report of an AE needs to be updated, the investigator or coordinator can enter the initial report and any subsequent information updates, rather then rewriting all of the previously submitted details. Finally, the AEs listed in the iRIS system do not contain any participant identifiers but rather the unique code assigned to subjects when enrolled. This additional measure helps to protect patient safety and confidentiality.

If you have questions about iRIS, please contact Ross Gillman; rossg@rockefeller.edu, (212) 327-8930; Ummey Johra; ujohra@rockefeller.edu, (212) 327-7877; or Donna Brassil; dbrassil@rockefeller.edu, (212) 327-7886.