Webinar Duration: 90 minutes

RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)

SPEAKER: Charles H. Pierce

When the PI signs the FDA form 1572 (for IND studies) or the “Statement of the Investigator (for IDE studies), she / he is signing a legally binding document committing themselves to follow all of the appropriate regulations. This talk, by a physician investigator, will go over the regulations in a user friendly way. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the “Principles of GCP”. Covered also will be what the practices are that ensure subject safety and credible data, which are the hallmarks of GCP.

Learn how well-controlled and well-conducted clinical trials that follow the Code of Federal Regulations and the Principles of GCP are important to both sponsors and CRO’s / investigator sites. See how compliance with the Regs and Good Clinical Practice will ensure quality data, speed up the review process, and decreases the costs to sponsors. This Webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines.

Additional responsibilities are clearly outlined in The GCP Guidelines of the ICH E6 (4.1 to 4.13). These 13 areas are described and discussed. Then there is the Compliance Program Guidance Manual (CPGM) 7348.811. To follow the regulations is Good Clinical Practices (GCP) and common sense. To not know or not follow these regulations is folly.

Why should you attend: All CRO’s, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the Regulatory processes and what the PI must know. To undertake Clinical Research without knowing what one is responsible for is irresponsible.

Areas Covered in the Session:
– The Investigators role in the clinical research process
– The concept of and the purpose of “GCP”
– The nine “commitments” on the FDA from 1572
– The thirteen ICH Principles of “GCP”
– The ICH definition of “GCP” and how it is applied
– The Regulatory requirements to follow to be GCP compliant
– Who, in the clinical research team is responsible that GCP is followed?
– How to be sure CPU / Site staff know their role in maintaining GCP

Who Will Benefit:
– Personnel in the Pharmaceutical
– CRO industry Conducting Clinical Trials including
– Sponsor Senior Management
– Project Managers
– CRA Managers
– QA/Compliance persons
– In CRO’s and sites, Those benefiting the most would be: Principal Investigators and sub investigators
– Clinical Research Scientists
– Safety Nurses
– Clinical Research Associates (CRAs) and Cordinators (CRCs)
– Recruiting staff
– QA / QC auditors and staff
– Clinical Research Data managers

Educational Objectives(S)
Upon completion of this activity, participants will be able to:
– Discuss how well-controlled and well-conducted clinical trials that follow the Code of Federal Regulations and Principles of GCP are important to both sponsors and CRO’s investigator sites.

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 CFMC and MentorHealth. CFMC is accredited by the ACCME to provide continuing medical education for physicians.

CFMC 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.

Obtaining Certificate of 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.

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.