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Data management plan

CRF design, annotations and validation


Data Management Committee & Study Support Center

Queries generation, DCF submittion

PhV handling & Safety Reports

CDISC, SDTM and ODM standards

Statistical Analysis

Data Management Plan

DMP defines the strategy and decisions made in relation to data management activities of the clinical study, including standards, processes, responsibilities and timelines. It also describes all data management deliverables and responsibilities of study personnel. DMP is an essential document to ensure quality, accuracy of data, compliance with GCP guidelines and reduce any associated risk. DMP is tailor made per study by Infoset according to the sponsor’s requirements or templates.