Course "Clinical Data Management Seminar" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Why should you attend:
Disclaimer: This seminar is not endorsed by, directly affiliated with, maintained, authorized, or sponsored by the Society for Clinical Data Management or any other clinical research society. All products, processes, and company names are the registered trademarks of their original owners. The use of any trade name or trademark is for identification and reference purposes only and does not imply any association with the trademark holder of their brand.
Clinical data management (CDM) is paramount for 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.
Who Should Attend:
- Study Investigators
- Data managers
- Data processors
- Site Personnel
- Clinical Research Associates
- Clinical Project Managers/Leaders
- Study Sponsors
- Professionals in pharmaceutical, medical device, clinical and biotechnology research who oversee or work with data collection and management
- Staff in the above fields who work with data collection/management and require training in CDM
- Compliance auditors and regulatory professionals who require a knowledge of CDM in assessment of study protocols and reports
For more information about this conference visit https://www.researchandmarkets.com/research/4rz43s/two_day_clinical?w=4