1. Risk Based Monitoring, Sponsor’s Experience Rital Lippman Barnes Clinical Research Manager, MSD

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3. Agenda Process and parameters for deciding the RBM Lessons learned and recommendations 3

4. Process and Parameters for RBM (1) Study Phase Study Complexity – Protocol design- e.g. procedures, diaries, drug dispensing and administration process – Study Population

5. Process and Parameters for RBM (2) Decision of Sampling Process – e.g. e- Randomizer, full patient review, if they are mandatory data points Decision of Sampling Parameters – Pre-defined data points for SDV and for SDR 5

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7. 7 EXCELLENT CONNECTIONS with site

8. Lessons Learned- Prior to study start (1) Head Quarters (HQ) Level – For every study define CRITICAL data points that are 100% Source Data Verification (SDV) for all subjects – Define what data that needs to be SDR (Source Data Review) – Sample size big enough to assure quality is maintained 8

9. Lessons Learned- Prior to study start (2) Subsidiary Level – Invest in excellent training to all site study team prior to study start – Know your site processes prior to study start 9

10. Lessons Learned- After study start Keep the full patient picture Allow local subsidiary management flexibility in changing the global sample size Site experience and professionalism 10

11. Summary 11