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Ensuring Data Integrity and Safety in Clinical Research


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Who should attend?

Clinical Research Scientists (PKs, Biostatisticians) Safety Nurses Clinical Research Associates (CRAs) and Cordinators (CRCs) Recruiting Staff QA / QC Auditors and Staff Clinical Research Data Managers

Details

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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

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