New Training tab
The IRB often receives help tickets from study coordinators asking for access to the CITI training records. Since administrative access to the CITI database is not possible, we will now be uploading CITI completion reports directly into OSIRIS. The Training tab will be displayed in the row of tabs on the approved study workspace. The courses listed are study specific and based on the requirements for that study (i.e., Investigator initiated IND/IDE, COI). The reports will be uploaded nightly so there may be a delay from completion to posting in OSIRIS.
During the course of testing, we have identified a problem that several users have created duplicate HSConnect accounts. Therefore, if CITI completion reports are not displayed and the individual has completed the training, email us at email@example.com. If you know the individual has created duplicate accounts, contact the HSConnect Support Team directly at firstname.lastname@example.org or call 412-648-2222 so the accounts can be merged.
Use of Continue/Save Functions
When using the Add or Update button to upload text or documents in OSIRIS, remember to click on the Continue or Save link in addition to the OK button located in the pop-up window. If this is not done, the content may not be displayed in the change log.
Off-Label Drug Use
Physicians are permitted to utilize drugs in an off-label manner during the course of clinical care. However, when using drugs in research for purposes outside of the FDA approved product labeling, there are additional regulatory requirements that need to be addressed. Before responding to the drug questions in the IRB application (Section 2 of OSIRIS), remember to check the FDA Online Label Repository available at http://labels.fda.gov which is an excellent resource to verify approved uses.
Waiver of Consent Request Limited to Review of Medical Records
It is often difficult for the investigator to identify the exact number of the medical records that will be accessed when conducting a chart review. Therefore, the IRB is now requesting that the approximate number of medical records that will be accessed be provided in question 4.7.1 (justification for the waiver of consent). Investigators should continue to -1 in question 3.11 for the number of subjects to be enrolled.