AURA IBC Fundamentals 1 Agenda q What is

AURA IBC Fundamentals 1

Agenda q What is AURA IBC q User Roles q Review Cycle q Smart. Forms q System Notifications q AURA IBC Resources System Overview q Navigation q Activities q Submissions § New Protocol § Resubmission § Amendments 2

At the END of this session You will be able to: q Navigate AURA IBC q Create a new protocol q Link FP to Protocol q Submitting for IBC Review q Respond to IBC Reviewer comments q Locate your approved documentation q Submit Resubmissions and Amendments 3

What is AURA IBC ? AURA-IBC is the new web-based Biosafety protocol submission and management system. !!! BENEFITS ~ BENEFITS !!! q Access approved protocols and protocols you’re listed on while on or off- campus! q Simplifies routing for review, tracking, and amendments of all submissions q Status of IBC submissions in review will be available online q Receive e-mail notifications when action is required on a protocol 4

User Roles provide access to AURA IBC, submission and review of studies. q IBC User (PI and Staff) q IBC Specialist q BSO (Bio. Safety Officer) q IBC Member (Committee Member) q IBC Chair 5

Review Cycle 6

Smart. Form records details of the research submission including general information, study staff, related research, hazard identification, documentation, acknowledgements and more. The Smart. Form includes the same questions you are familiar with in previous submissions. Only some questions have changed. Please be sure to complete form in its entirety. 7

Tools Additional tools simply the submission process and provide real time information about studies for PI’s and Staff. Just a few examples below: History Log Tracks the review process and all actions performed on the study by all users Protocol Personnel Lists all study staff involved and allows additional/ deletion of study members in one quick process. Documents Stores all documents relevant to the study that may be uploaded by all users 8

Notifications When listed as PI or Study Staff on a study, AURA IBC will send an e-mail notification to alert you when a study requires you to perform an activity. The IBC Specialist has requested changes to your protocol. 9

AURA IBC Resources http: //aura. uchicago. edu/page/ibc-training -resources 10

IBC Contacts William Pugh Director, Regulatory Compliance for Laboratory Programs (773) 834 -4765 wpugh@uchicago. edu Olivia Cochet IBC/IACUC Administrator (773) 834 -4277 ocochet@uchicago. edu Pam Postlethwait IBC/IACUC Administrator (773) 834 -5850 ppostlet@uchicago. edu Stacy Herrera IBC/IACUC Administrator (773) 834 -0540 shherrer@uchicago. edu Esther Sandifer Project Assistant (773) 702 -9203 esther 47@uchicago. edu 11

Using AURA IBC 12