Summary of clinical data & management

Summary of clinical data & management

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  CLINICAL DATA COLLECTIONAND MANAGEMENT
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  CONTENTS  Introduction  DataCollection v/s Data Management  Types of data collection  Communication  Processes Before Data Collection  Processes During Data Collection  Processes After Data Collection  References 2
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  INTRODUCTION Clinical trial datamanagement involves a set of processes that must be executed successfully to turn out reliable clinical, control and administrative data to a central location such as coordinating center, a data center, or a resource center. New developments in computer hardware and software technology have made clinical trial data collection and management timely, effective, and reliable for conducting a successful clinical trial. 3
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  DATA COLLECTION v/sDATA MANAGEMENT The two major computer applications in conducting clinical trials are data collection and data management having a distinct role in clinical trials. • Data collection Data collection in the clinical trials consists of the processes of collecting reliable clinical, control, and administrative data from the trials participating sites with agreed- upon methods and procedures to record the collected data and send them to a central location. • Data management Data management is the process of accumulating collected data into a master database in central location while ensuring their security, validity, and completeness by generating quality assurance reports to monitor the progress of the trial. Data management is also the work that involves the planning, development, implementation and administration of systems for the acquisition, storage and retrieval of data. 4
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  TYPES OF DATACOLLECTION SYSTEM Types Participating sites Co-ordinating center Pure Paper Based • No computer hardware/software • Complete paper form • Computer hardware/software • Enter form into electronics files Pure Electronic Based • Computer hardware/software • Enter data directly into a computer system • Computer hardware/software • Process electronic batch file through a computer system Hybrid Paper Based • No computer hardware/software • complete e form • Enter forms directly into a centralized computer system • Computer hardware/software 5
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  COMMUNICATION Communication is theprocess of sending information from one location to another or from one person to another by means that enable the sender to send the information to the intended recipient and the intended recipient to receive, retrieve, and interpret the information. Clinical trial staff have available many communication tools that have revolutionized the way they are able to share comments, exchange ideas, send and receive data, and solve the unexpected problems. 6
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  Examples of thetypes of communication are as follows- • Direct contact meetings • Mail carrier • Telephone • Fax • E-Mail • Websites • File transfer protocol • Video conferencing 7
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  PURE PAPER BASEDSYSTEMS • Pure paper based data collection systems have predominant in clinical trials. • Pure paper based data collection method to be the safest and most reliable approach to data collection.  Suitability and hardware/software Requirements  Pure paper based data collection systems are most suitable for small and short-term studies.  Their advantages are that no computer hardware or software is needed at the participating sites because data are recorded manually on the paper forms that are transferred to the centralized location in batches.  Design and implementation  Pure paper based data collection systems use paper forms that can be designed with any graphical or word processing software such as Adobe Page Marker, Microsoft Word, or MS PowerPoint.  Managing Data  Pure paper based data collection systems are inefficient in that they require large data editing overhead. 8
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  ELECTRONIC BASED SYSTEM Electronicbased data collection and management systems have revolutionized data collection and management.The advantages of such systems over the traditional pure paper based data collection and management systems include their ability to- • Provide cleaner data faster • Provide up-to-date interim progress reports in a timely • Dramatically reduce the time from last patient visit to final database lock out. Electronic based data collection and management systems use various computer hardware and software technologies: • Centralized system • Distributed system • Wireless system • PDF- Based system • Web based system • Direct system 9
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  HYBRID SYSTEM Hybrid systemare those system that employ various strategies to collect data : In such system, data may collect on paper forms as patient self-administered questionnaries, while additional data may be downloaded from centralized databases. • Paper data collection with centralized interactive data entry. • Paper data collection with centralized batch data entry. • Paper data collection with direct data transfer to centralized DMS. • Integration of distributed system with remote server over the internet. 10
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  Processes Before DataCollection All processes for data collection and management are defined, addressed, and accomplished before data collection begins. These processes include determining the type of the data collection and management systems, developing the systems, defining procedures for subject recruitment, registration, screening, randomization, and treatment dispensing.  Choosing a data collection and management system  Hardware and software selection  Form and system design  Protocol and system rule  System development  System validation  Staff training 11
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  Processes During DataCollection  System Evaluation  Subject Management  Data Quality Assurance  Treatment Dispensing  Handling Unexpected Events  Data Transformation 12
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  • Processes AfterData Collection  Data Lockout  Data Retention  Data Archiving  Data Sharing 13
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  REFERENCES • http://www.tech-encyclopedia.com/data-management.htm • www.dori.duke.edu/patient/glossary.jsp 14
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  THANK YOU 15