Upcoming Events at DoubleTree by Hilton Philadelphia Airport
Thu Apr 12, 9:00 AM - Sat Apr 14, 6:00 PM
DoubleTree by Hilton Philadelphia Airport
4509 Island Avenue, Philadelphia, PA 19153, Philadelphia, PA 19153
Community: Greenwich Village
Description
Course "Good Clinical Data Management Practices (GCDMP)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Event Details
Course "Good Clinical Data Management Practices (GCDMP)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.
Overview:
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
Agenda:
Day 1 Schedule
Lecture 1 (90 Mins):
GCDMP: The Reasons and The Requirements
• GIGO = Garbage In, Garbage
Overview:
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
Agenda:
Day 1 Schedule
Lecture 1 (90 Mins):
GCDMP: The Reasons and The Requirements
• GIGO = Garbage In, Garbage
