1. Larix – a full service Clinical Research Organisation
N o r d i c • r o b u s t • f l e x i b l e

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

3. Responsibility
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

4. How we do it
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

5. How we do it
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

6. Challenges
CRO process - DM assignment with CO at different CRO/Sponsor
Sponsor processes - CTMS
Definitions – What is considered to be a PD
Reporting – Who should report and to whom
Reporting format – Excel, Word, eCRF

7. Challenges
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 – eCRF, SDTM

9. Solutions 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 eCRF, per subject

10. Thank you for your attention