Clinical trials data Management process
Clinical Research data management is the expert application of informatics theories and methods to the definition, collection and processing of data for clinical studies and the design of associated work and data flow. Clinical Research Data Management assures collection, integration and availability of data at appropriate quality and cost. Clinical Research Data Management supports the conduct, management and analysis of studies across the spectrum of clinical research as defined by the National Institutes of Health (NIH). The ultimate goal of CRDM is to assure that data support conclusions drawn from research. Achieving this goal protects public health and confidence in marketed therapeutics.
The clinical research data manager plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry. The clinical research data manager is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the data manager ensures that data is collected, validated, complete and consistent. The data manager liaise with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical research data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical research data manager transfers data for statistical analysis
Standard Operating Procedures
Standard Operating Procedures (SOPs) describe the process to be followed in conducting data management activities and support the obligation to follow applicable laws and guidelines (e.g. ICH GCP and 21CFR Part 11) in the conduct of data management activities.
Data management plan
The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, clinical data management system to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedures to be applied.
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
Adaptive and Flexible Clinical Trials
Book (CRC Press)
Clinical Trials Data Management and Biostatistics Services?
Suggest me a genuine concern for clinical trials data management and bio statistics services?
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