21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research

Duration: 90 Minutes
Instructor: Charles H Pierce
Webinar Id: 800138


One Attendee


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 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential.

Basically electronic records and electronic signatures must be trustworthy, reliable and generally equivalent to paper records and signatures executed on paper. The differences between the traditional paper system and an electronic system is significant. One must know and follow the Part 11 code. System validation has many items to follow but none more important than the who, what, and when aspect of the Data / Audit Trail. These trails must be secure, operator independent, computer generated, date & time stamped, and (most importantly) available for the FDA reviewer. SOPs and staff training is often what separates the good from the not good CRO or systems. This presentation is for the non-computer literate clinical research staff.

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?
  • The Role of Standard Operating Procedures and staff training in a functional Electronic Data Capture system
  • What are the suggested controls to ensure authenticity, integrity and confidentiality of your EDC system?

Who will Benefit:
  • Principal Investigators and sub investigators
  • Clinical Research Scientists (PKs, Biostatisticians)
  • Safety Nurses
  • Clinicl Research Associates (CRAs) and Cordinators (CRCs)
  • Recruiting staff
  • QA / QC auditors and staff
  • Clinical Research Data Managers

CME Credit Statement
This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Colorado Foundation for Medical Care (CFMC) and MentorHealth. CFMC is accredited by the ACCME to provide continuing medical education for physicians.

Colorado Foundation for Medical Care designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Other Healthcare Professionals Credit Statement
This educational activity has been planned and implemented following the administrative and educational design criteria required for certification of health care professions continuing education credits. Registrants attending this activity may submit their certificate along with a copy of the course content to their professional organizations or state licensing agencies for recognition for 1.5 hours.

Disclosure Statement
It is the policy of Colorado Foundation for Medical Care (CFMC) and MentorHealth that the faculty discloses real or apparent conflicts of interest relating to the topics of the educational activity. All members of the faculty and planning team have nothing to disclose nor do they have any vested interests or affiliations.

Continuing Education Credit

Colorado Foundation for Medical Care (CFMC) hosts an online activity evaluation system, certificate and outcomes measurement process. Following the activity, you must link to CFMC’s online site (link below) to complete the evaluation form in order to receive your certificate of credit. Once the evaluation form is complete and submitted, you will be automatically sent a copy of your certificate via email. Please note, participants must attend the entire activity to receive all types of credit. Continuing Education evaluation and request for certificates will be accepted up to 60 days post activity date. CFMC will keep a record of attendance on file for 6 years.

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. Dr. Pierce serves as an advisor to several clinical research organizations, sits on industry based boards, and is VP of Medical Affairs for Harrison Clinical Research GmbH, a global CRO headquartered in Munich.

He has been in the Clinical Research Industry for 20 years, has been involved in developing Phase I & IIa Clinical Pharmacology Units, Investigator and staff GCP training, and medical monitoring in both drug and device studies.

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