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Register online, by phone (800) 349-1935,or fax (800) 712-5569
Who should attend Clinical Data Management (FDA E6 GCP Guidelines): 2-Day In-Person Seminar
Study Investigators, Data managers, Data processors ,Statisticians, Site Personnel, Clinical Research Associates, Clinical Project Managers/Leaders, Study Sponsor.
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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


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.

Seminar Fee Includes:

Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar
DOWNLOAD BROCHURE
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:

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

Seminar Summary:

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. (see full course description)

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