Current issues for research focus of upcoming seminar
GEAR session aimed at clinical research professionals, associates and coordinators, and registered nurses
Keeping up to date with current trends in medical research is the focus of an upcoming Gaining Essentials About Research (GEAR) session.
The session titled "Important Topics for Clinical Research Professionals in these Changing Times" will take place at 8 a.m. Wednesday, August 18 in the Cranmer Auditorium at Norton Healthcare Pavilion at 315 East Broadway in Louisville.
To register, contact Holly Horn at holly.horn@nortonhealthcare.org, or (502) 456-7193.
Presenting this month's GEAR meeting is Aureus Research Consultants LLC.
The session will discuss four main topics:
1. GCP compliance: How small mistakes can have big consequences
- Identify the effects of errors/mistakes on the outcome of a clinical study
- Compare the terms protocol, noncompliance and waiver
- Describe methods to ensure consistent source documentation
- Identify the expectations regarding timely review of study-specific data
- Define appropriate delegation of study activities
2. Essential documents: Maintaining the regulatory binder
- Describe the importance of maintaining the regulatory binder during the research process
- Identify the contents of the regulatory binder required for conducting a clinical trial
- Describe the maintenance of the regulatory binder during a clinical trial
3. Understanding site monitoring reports and follow-up letters
- Identify current practices utilized by sponsors and CROs in documenting site monitoring visits
- Discuss common notations in monitoring follow-up letters and how these routinely translate into observations within a site monitoring report
- Compare and contrast the request-content of site monitoring reports, as per ICH E6 guidelines, to those reports routinely performed by sponsors and CROs
- Describe methods that both the site and monitors can utilize to ensure transparency in site monitoring reporting practices
4. FDA inspections: What you can expect in an audit
- Define the phrase FDA audit, other audit terminology and expectations from an FDA audit
- Discuss differences between an audit and a routine monitoring visit
- Identify types of FDA audits and how to participate in an FDA audit
A certificate of attendance will be provided to each participant at the end of the session; however, total contact hours are pending.
Continuing nursing education contact hours are provided by the Louisiana State University Health Sciences Center School of Nursing to those who complete the course in its entirety. LSUHSC School of Nursing is an accredited provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.
