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Protocol Deviations – How we do it, challenges and solutions Presenters: Maria Weibull (Sr DM) and Lisa Thell (Director DM, Sweden) )

Responsibility § § § 3 Clinical Trial Manager (CTM) - Maintenance of PD log - Preliminary assessment of PD (minor/major) - Planning/conduct of any corrective action needed Clinical Research Associate (CRA) - Identifying and reporting, as they occur - Support CTM in maintaining the PD log Data Manager (DM) - Ensuring the reviewed and assessed PD log is available prior to Database lock Communication Proactivity Quality on time

How we do it § § § 4 Protocol Deviation Form (Word) / Log (Excel) Information collected: Level (Subject, Site, Study), Collection/Start/Stop date, Category (IC, IE…), Classification (assessment), Description, Corrective/Preventive actions, Reason for deviation, Signatures Unresolved discrepancies list (By-passed checks) Presented at the latest at the Database Lock meeting SDTM dataset Excel sheet is read into SAS Communication Proactivity Quality on time

How we do it § § § 5 Define logical checks in DVP – Only covers data errors, clinical findings are not detected. Query PD discrepancies / Missing data Offer listings of PD discrepancies / Missing data Ensure PD log is received and available at Database lock meeting Deliver PD log to SDTM team Communication Proactivity Quality on time

Challenges § § § 6 CRO process - DM assignment with CO at different CRO/Sponsor processes - CTMS Definitions – What is considered to be a PD Reporting – Who should report and to whom Reporting format – Excel, Word, e. CRF Communication Proactivity Quality on time

Challenges § § § 7 Review of PD – Why, Who, When DM not always part of review. Lack of review could lead to: Loss of information, No time for corrective/preventive actions, delay of DB Lock, affects data quality, safety concerns, PD misclassified or even lost Assessment – Who, When – What if sponsor/investigator disagrees? Study, Country, Site and Subject PDs – e. CRF, SDTM Communication Proactivity Quality on time

8 Communication Proactivity Quality on time

Solutions § § § § 9 Specify PDs and assessment thereof in protocol Clear routines and timelines for reporting Training – CRA and Site Continuous review as a part of oversight Specify all PDs as checks in Data Validation Plan (DVP) – allow listings to be created during study Harmonize form and PD log with SDTM Collect PDs in e. CRF, per subject Communication Proactivity Quality on time

Thank you for your attention Communication Proactivity Quality on time