Summary of clinical data & management

computational modelling of drug

1. CLINICAL DATA COLLECTION AND MANAGEMENT

2. CONTENTS Introduction Data Collection v / s Data Management Types of data collection Communication Processes Before Data Collection Processes During Data Collection Processes After Data Collection References

3. INTRODUCTION Clinical trial data management 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.

4. DATA COLLECTION v/s DATA MANAGEMENT T he two major computer applications in conducting clinical trials are data collection and data management ha ving 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.

5. TYPES OF DATA COLLECTION 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

6. COMMUNICATION Communication is the process 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.

7. Examples of the types of communication are as follows- Direct contact meetings Mail carrier Telephone Fax E-Mail Websites File transfer protocol Video conferencing

8. P URE PAPER BASED SYSTEMS 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.

9. ELECTRONIC BASED SYSTEM Electronic based 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

10. HYBRID SYSTEM Hybrid system are 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.

11. Processes Before Data Collection 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

12. Processes During Data Collection System Evaluation Subject Management Data Quality Assurance Treatment Dispensing Handling Unexpected Events Data Transformation

13. Processes After Data Collection Data Lockout Data Retention Data Archiving Data Sharing

14. REFERENCES http://www.tech-encyclopedia.com/data-management.htm www.dori.duke.edu/patient/glossary.jsp

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