Ensuring Data Integrity and Safety in Clinical Research

Fremont, CA
Clinical Research, Conference on clinical trials, Electronic Data Capture system, Clinical Research Scientists, Research Data Managers

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

Schedule of Presentations:

Tuesday, January 9, 2018
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