Seven Mistakes Commonly Made During a Monitoring Visit
| Date: Dec. 15, 2010 |
| Time: 12:00 pm - 1:30 pm Eastern Time US; Please check your time zone prior to the webinar |
| Registration Deadline: Dec. 14, 11:59 pm Eastern Time |
Contact Hours: CBRN, ACRP
Earn 1.5 contact hours (only purchaser eligible to receive contact hours) |
| Level: Intermediate |
| Member Rate: $99.00 |
| Regular Rate: $124.00 |
|
|
Program Description
Monitors play a crucial role in the successful completion of a clinical trial and are often the only liaison between the Sponsor and the site. Several FDA warning letters have been recently issued that document the inadequate monitoring practices in the industry. It is critical for monitors to be armed with the appropriate knowledge and training to adequately and successfully conduct their monitoring visits.
This session will cover the top seven mistakes commonly made by the monitor during a monitoring visit and how to avoid them:
- Avoiding direct communication with the PI
- Having inadequate expertise with the protocol
- Settling for inadequate source documentation
- Focusing on details that are inconsequential
- Not asking the right questions
- Leaving monitoring responsibilities for the “next visit”
- Lack of timely follow-up
Teaching tools will include slides, warning letter examples, and polling questions.
Target Audience
This webinar is intended for Clinical Research Associates (CRAs), Senior CRAs, Clinical Research Coordinators (CRCs), and Clinical Research Administrators working in biotech companies, contract research organizations (CROs), device companies, pharmaceutical companies, and site management organizations (SMOs).
Learning Objectives
Upon completion of this webinar, attendees should be able to:
- Identify at least 4 mistakes made by monitors during monitoring visits.
- List 3 strategies to improve the effectiveness of the monitoring visit.
- Implement the monitoring tracking/trending tools discussed during the session
Presenter
Carol Bognar is a Senior Director at The Weinberg Group. She has global responsibility for Good Clinical Practice (GCP) consulting services to Clients in the pharmaceutical, biotechnology and medical device industries and oversees the allocation of resources. She provides international project management and has extensive expertise in QA Services including the performance of over 300 GCP audits and has over 25 years experience in healthcare, beginning as a Registered Nurse.
Disclosure Statement
Ms. Bognar states that she has no actual or potential financial conflict of interest in relation to this program.
Accreditation Information
Continuing Nursing Education
The California Board of Registered Nursing approves the Association of Clinical Research Professionals (ACRP) as a provider of continuing nursing education. ACRP’s webinar program provides 1.5 contact hours of continuing nursing education credit (Program Number 11147-2010-321).
Association of Clinical Research Professionals
The Association of Clinical Research Professionals (ACRP) provides 1.5 continuing education credits for the completion of this educational activity with the completion of the online evaluation form. These credits can be used to meet the certification maintenance requirement (Program Number ACRP-2010-WEB-321).
Please note: Webinar presentations are delivered online at the scheduled presentation time only and will not be distributed prior to or following the event. Speakers maintain all copyrights on presentation materials and duplication or preservation of webinar content is strictly prohibited.