Overview:

The main principle is to follow exactly the signed and approved (IRB + PI) Protocol to the letter. This, in fact, is included on the FDA Form 1572. In the current regulatory climate, GCP Investigator site audits are a part of the clinical trail process. Sponsors should anticipate more inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site. Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of investigators as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections.

It will be important to see what the FDA regulations and the ICH GCP recommendations are in this regard. The key is that the PI and all clinical staff know and follow the research plan (Protocol) exactly as it is written. To do this is ethical research. To not follow the protocol and document study conduct carelessly 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 FDA processes and why the Sponsor's / CRO's Monitors are so important.

Areas Covered in the Session:

• What doe the FDA look at when Auditing/Inspecting a study?
  
• The Sponsor's responsibility in monitoring study conduct
  
• Components of a sponsor monitoring system beyond SOPs
  
• The nature of adequate oversight of all staff and non-staff
  
• The importance of Protocol knowledge in preventing errors
  
• How do sites prepare for an audit / inspection
  
• The measures to ensure quality monitoring

Who Will Benefit: This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including:

• Senior Management
  
• Project Managers
  
• CRA Managers
  
• QA/Compliance persons
  
• Principal Investigators and sub investigators
  
• Clinical Research Scientists (PKs, Biostatisticians, ...)
  
• 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 FDA processes and why the Sponsor’s / CRO’s Monitors are so important.

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 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.