Ensuring Data Integrity and Safety in Clinical Research

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: [email protected]

Visit official site

WHEN AND WHERE

09 January 2018
United States of America

ORGANIZER

Event Manager

Add to Google Calendar

Added 6 years ago by Compliance4All on Education