Clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO). CDM involves all aspects of collecting, processing, and interpreting information. There are many types of computer applications and database systems to support data collection and management. However, there are elements of CDM that apply across the board.
Review and approval of drugs or devices by regulatory agencies requires the assumption that the data presented are valid and reliable. Integrity of the data is paramount to ensure confidence in the results and conclusions you will make.
This seminar is based on FDA E6 GCP Guidelines which are the basis of effective data quality management. Even if your research is not FDA regulated, the information you learn in this course will help to ensure a robust data collection and management plan. The information conveyed in this course will also assist investigators in setting up processes for smoother data monitoring and auditing.
Examples of CRF’s and required documentation will be presented. Data collection and preparation techniques will also be demonstrated. Additionally, this workshop will provide you with the knowledge and tools needed to assure a CDM plan that holds up when the inevitable deviations from protocol occur.
Learning Objectives
Brief detail about GCDMP
21 CFR Parts 11, 312.62, 812.140
NIH Policy (SOP 15, 16, 17, 19)
Data Management Plan
Data Privacy
Data Collection
Data Quality
Data Review
Who Should Attend:
Professionals in pharmaceutical, nutraceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management will be benefited by this seminar.
Study Investigators
Data managers
Data processors
Statisticians
Site Personnel
Clinical Research Associates
Clinical Project Managers/Leaders
Study Sponsors
Clinical Research Organizations
Clinical and Biotech Start-ups
Individual researchers in health and biotech fields.
Study Investigators
Medical and Health Sciences
Clinical Trials
Clinical Research
Physicians
Medical Students
Graduate Students in the Biological Sciences
Researchers
Staff in the above fields who work with data collection/management and require training in GCDMP
Compliance auditors and regulatory professionals who require a knowledge of GCDMP in assessment of study protocols and reports