IRT & ecoa: The Good, The Bad & The Ugly YPrime, inc. All Rights Reserved

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2 What we would like to share: Overview of the concept of IRT and ecoa integration Benefits and challenges of scanning in an integrated system Using an integrated system for drug accountability and reconciliation Lessons learned Key takeaways

3 How to incorporate the following functionalities: Stratification factors Controlled substance accountability Subject Dosing compliance

4 Overall concept of IRT & ecoa integration The Good The Bad The Ugly Single sign-on Shared portal Avoids multiple logins Streamlined subject set-up process Avoid dependencies ecoa works offline, IRT does not Any data collected in ecoa needed by IRT, to operate as designed, can cause blockers If ecoa captures stratification criteria, IRT would rely on this to randomize a subject Consider presenting strata factors in IRT as selected in ecoa. Allow site user to manually select/confirm the option.

5 Scanning at dosing vs confirming material status updates - (acknowledgement, dispensation, etc.) The Good Scanning at dosing Subjects can use device to scan Medication ID so that you have full traceability of their dosing The Bad Scanning for Material status updates at the site Consider the flow of kit statuses with or without the scanning steps Consider allowing the standard flow of kit statuses with or without the scanning steps The Ugly During order acknowledgement, what if a scanning step is missed? At dispensation, what if the pharmacist forgets to scan before dispensation? Consider sending alerts if steps are skipped instead of making status updates. If the pharmacist forgets to scan a kit at dispensation, still assign that kit as normal, but send an to the study team to notify them of the missed scanning event.

6 Drug accountability and reconciliation The Good The Bad The Ugly Daily dosing reported in ecoa, and displayed in IRT can provide information for site-users to account for IP and reduce the need for paper logs Used as reference for accountability Possibilities for custom reporting ediary compliance or device connectivity issues could occur and block subject progression if a full integration is used Since 100% ediary compliance will rarely be achieved, if your system is driven by subject reported dosing then 100% reconciliation and accountability will be difficult Consider displaying accountability and compliance expectations, but allowing the site user to report actual usage and provide the final reason for discrepancies.

7 IRT & ecoa: lessons learned Begin with the end in mind All parties need to have a clear vision of the end goal. The Sponsor will be best served to have initial conversations on scope before engaging the vendor. Work with your vendor to clearly define your expectations.

8 IRT & ecoa: lessons learned Consider the regulatory impact on ecoa versus IRT Subject reported ecoa data SHOULD NOT be amended after the initial entry Site reported IRT data CAN be easily amended via a data update or correction

9 IRT & ecoa: lessons learned Integrate data for site user reference ONLY Display ecoa data in IRT for the site user to evaluate and make an informed clinical decisions. No subject flows in IRT should be driven by subject reported data.

10 IRT & ecoa: lessons learned With the benefits of a joint system, comes the challenge of managing a joint system Think ahead when planning timelines, system documentation and a joint UAT. ecoa subject-facing materials require IRB submission and should be accounted for during the build and maintenance periods for timely updates to a joint system.

11 IRT & ecoa: Takeaways Key Takeaways: Avoid dependencies Allow for Clinical Decision making Plan ahead