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Site language : English - Français
Ref : 26166
Event :Ensuring Data Integrity and Safety in Clinical Research

Date :Tuesday January 09th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

Overview:  
Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11.
 
Why should you Attend: 
The increasing use of computers and increasing complexity, all persons who have any data input requirements to know the set-up and function of the systems they are using. Forewarned is forearmed.
 
Areas Covered in the Session:
The CFR definitions of Electronic Record, Electronic Signature, Closed System, Open System, Data Trails, and assure that your data is secure and valid?
What needs to happen to make data trails secure and real
What questions should you internal QA department ask to be sure your system is functioning correctly?
What controls need to be in operation for an open system?
What are the controls needed for a valid electronic signature?
 
Who Will Benefit:
Principal Investigators and Sub Investigators
Clinical Research Scientists (PKs, Biostatisticians)
Safety Nurses
Clinicl Research Associates (CRAs) and Cordinators (CRCs)
Recruiting Staff
 
Speaker Profile:
Charles H. Pierce MD, PhD, FCP, CPI is a consultant in the Clinical Research / Drug-Device Development arena specializing in bringing the message of GCP Regulations and Investigator Responsibility to the entire investigative team to help them understand the regulations as well as the ethics of research involving human subjects.
 
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Details

Ensuring Data Integrity and Safety in Clinical Research Pharmacy - Medicine - Management
clinical research, conference on clinical trials, electronic data capture system, clinical research scientists, research data managers
Professionals, Clinical Research Scientists Safety Nurses Clinicl Research Associates
100 1 --
English

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