The principal objective in a new drug development program is to assess the benefit / risk ratio. Learn what the risk information is that must be collected, documented and reported accurately. Learn why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects.
AE's are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge. To obtain 'commonality' in reporting, investigative sites require familiarity with one of the Adverse Event Terminology systems. As codified in 21 CFR 312.64(b), an investigator shall promptly report to the sponsor any adverse event that may reasonably be regarded as caused by, or probably caused by, the drug.
See Why determining the relationship between the study drug and an AE requires a practiced power of observation & great care (good medical judgment).
Why Should You Attend: With the increasing complexity of the Investigational Medicinal Products (IMP's), it behooves all who have any role in observing Study Participants to know the importance of accurately collecting all AE and SAE data.
Areas Covered in the Session:
Who Will Benefit:
- The definitions of Adverse Events, Serious Adverse Events, Unanticipated Adverse Device Effects and many more
- How to know what an Adverse Event is and when to report it or them
- Knowing the AE types and likelihood of finding "rare" events
- Understanding laboratory AEs and the "Reference Range" concept
- Common Mistakes in AE / SAE Reporting
- Reporting of Adverse Events - when and to whom and the use of AE Terminology systems
- How to record Adverse Events and assess causality - the algorithm
CME Credit Statement
- Principal Investigators and sub investigators
- Clinical Research Scientists
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- QA / QC auditors and staff
- Clinical Research Data Managers
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.
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.