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.
Joint Sponsor Statement
This activity is jointly sponsored by Colorado Foundation for Medical Care and MentorHealth.
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 are 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 separate the good from the not good systems. This presentation is for the non-computer literate clinical research staff.
This activity has been designed to meet the educational needs of physicians and other healthcare professionals.
Upon completion of this activity, participants will be able to:
DISCUSS CFR DEFINITIONS OF ELECTRONIC RECORD AND SIGNATURE, CLOSED AND OPEN SYSTEMS, DATA TRAILS AND HOW TO ASSURE DATA IS SECURE AND VALID
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.
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.
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.