Good Clinical Data Management Practices (GCDMP)

Added by globalcompliancepanel on 2018-01-04

Conference Dates:

Start Date Start Date: 2018-02-22
Last Date Last Day: 2018-02-23
Deadline for abstracts/proposals Deadline for abstracts/proposals: 2018-02-20

Conference Contact Info:

Contact Person Contact Person: Event manager
Email Email: [email protected]
Address Address: Los Angeles, Los Angeles, CA, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

Why should you attend:
Good clinical data management (CDM) is paramount for a successful research. After all, Garbage In, Garbage Out (GIGO).

CDM is involved in 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 Good Clinical Practice 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 cleaning techniques will also be demonstrated. Additionally, this workshop will provide you with the knowledge and tools needed to assure GCDMP’s that hold up when the inevitable deviations from protocol occur.

Who will benefit:
Study Investigators
Data managers
Data processors
Statisticians
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 GCDMP.
Compliance auditors and regulatory professionals who require a knowledge of GCDMP in assessment of study protocols and reports

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