BCIRG
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Data Management
The Data Management (DM) Team currently manages data from seven international breast cancer studies within the guidelines established by CIRG internal Standard Operating Procedures (SOPs), CIRG systems and processes, and sponsor guidelines when relevant. The department has a proven track record of achieved milestones and high quality deliverables. The department has been through many successful audits from CIRG sponsors and external consultants.
The department with its 45 employees has many years of clinical data management experience and is fully trained according to the CIRG standard training program (data management practices, programming, computerized system validation, ICH/FDA guidelines).
Our data management system is validated and 21 CFR Part 11 compliant. The system is a combination of modules which use an Oracle database and integrates with other applications in order to setup screens, perform data entry and run data validation tools.
DM Team is composed of:
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The Director
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Data Managers
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Data Coordinators
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Programmers
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Coding Clerks
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Data Entry Supervisor
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Data Entry Clerks
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Tracking / Filing Clerks
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Administrative Assistant
Global Data Systems and DM Team Goals of the are:
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To deliver results according to sponsors' expectations in terms of timelines, data quality and communication.
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To be compliant with ICH/GCP, FDA and other standards guidelines and practices.
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To ensure thorough documentation around the data management processes and the use of data systems.
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To hire and train highly competent individuals.
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To maintain, develop and upgrade systems which allows for fast, reliable data capture and data validation.
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To advance processes for delivery of high quality data reports.
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To communicate effectively and accurately with sponsors.
DM Activities are:
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Case Report Forms (CRFs) Design
The protocols are transcribed into detailed CRF pages that ensure proper data recording and accurate entry into the clinical database.
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Data Management Plan
The Data Manager writes the data management plan which describes all procedures to be followed and summarizes responsibilities.
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Clinical Database and Data Entry
By using standard tools and processes, a flexible and validated database system enables the department to meet sponsor requirements. Once the database and the data entry screens are setup, double data entry is performed.
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Clinical Data Validation
Data validation are developed based on the data management / data validation plan and data specifications. They include several types of listings as well as queries. They cover, and are not limited to, the verification of out of range values and inconsistencies between data and protocol compliance checks.
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Coding
All Adverse Events, medications and other data as required are coded according to standard dictionaries (e.g. MedDRA), internal global code lists and sponsor requirements.
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Data Transfers
Data is provided to sponsors in a mutually agreed format (e.g. SAS transport files) and when required (after testing).
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Filing and Archiving
CRFs and data validation tools are filed in a secured, access-controlled archive room. Daily data back-up is performed and archived according to standard IT procedures.
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Data Management Reports
The Data Management Reports summarize for the sponsor and project management major events related to data management processes and decisions. The sponsor receives regular updates and is intimately involved in data management-related decisions. Standard and study-specific documents are generated to provide an accurate description activities and performance.
