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.
- Regulatory guidelines for Clinical Data Management
- Best practices for data collection
- Responsibilities of personnel
- Case report form criteria
- Maintaining confidentiality of data
- Data storage and transferability
- Data preparation and quality assurance for accuracy
- Data monitoring plan criteria
- Data systems validation
- Adverse event reporting and coding criteria
- What to expect on a monitoring visit
- Troubleshooting and resolution of deviations from plan
Who will Benefit:
- 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