PPM Services and Ethical eAdjudication to Implement Clinical Data Management Including IVRS, EDC and Endpoint Adjudication Quality Control in a Phase II Study on Acne
SHIRE (SHPG)
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BASEL, Switzerland (PRWEB) December 13, 2018 Study Protocol Summary of QC Procedure1 – Patient Enrolment (with Ethical IWRS).2 - First Visit (with Ethical e-CRF®): IGA first assessment performed at the site.3 - Three photos captured with Apple iPad and transferred to each Site's BOX folder.4 - Central Staff Controls Photo anonymization in BOX.5 - Photos moved to eAdjudication® and submitted to Reviewers.6 - Reviewers (blinded) repeats IGA Assessment. 7 - eAdjudication® detects and tracks disagreement (alert to CRO)....8- Final Visit (with Ethical e-CRF): IGA second and last assessment performed at the site.… - steps from 3 to 7 repeated.Goal: The purpose of using an adjudication procedure is to ensure the consistency and quality of the acne assessment across study sites. In case of high disagreement rate between local and central assessments, a site may receive additional training (or even be closed) to preserve clinical data quality across the trial.PPM hopes to achieve higher qual
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