Advanced Monitoring Visit Documentation: Global Regulatory Authority Inspections and Sponsors
- Michael Hamrell, RAC, CCRA, RQAP-GCP, PhD, President, MORIAH Consultant
- Liz Wool, RN, BSN, CMT, CCRA, President and CEO, QD-QUALITY AND TRAINING SOLUTIONS
- Rebecca Carew, Sr. Manager, Process Management, Purdue Pharma, LP
- 10:00 – 10:10 am – Chapter Updates
- 10:10 – 12:00 pm – Educational Presentation
- $0 Chapter Members
- $0 ACRP Members
- $25 Non-Members
Going beyond the foundational principles, concepts and techniques for documenting monitoring oversight activities (remote, on-site-reports, follow-up letters), this session takes a 'deep dive' into documentation expectations and requirements as the evidence for adherence to FDA, global regulatory authorities, and ICH E-6 GCP requirements. Many organizations in their quest for enhancing quality control have implemented 'template monitoring documentation tools' (visit reports, phone contacts). However, this has resulted, for some, in 'templateitis', whereby, the box checking does not convey 'everything the CRA-Site Monitor' did with the site, site staff or PI. Without the detail, the reader - audience of this documentation will think 'so I have a perfect site'? Conversely, CRAs and Site Monitors have not been provided guidance: what is 'important to document' and 'what detail is important?' What really matters to the sponsor, auditors and the regulatory authorities/FDA inspectors?Upon completion of this Webinar, attendees should be able to:
- Explain the site monitoring oversight expectations by global regulatory authorities.
- Predict sponsor expectations for site monitoring oversight interactions and documentation.
- Evaluate monitoring visit activities and the required documentation to ensure 'audit/inspection readiness'.
CRCs, CRAs, Investigators, Auditors, Project Managers, Regulatory, Affairs/Compliance, Data Managers (Site, Sponsor, CRO), Medical Monitors, Medical Officers, Project Physicians, Quality Assurance, Clinical Research Administrators, and anyone in the clinical research industryContact hours:
2 Contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours. To receive contact hours:
Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate. Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
No refund unless the event canceledLevel:
Contact Joe Coffie at firstname.lastname@example.org
or Mary Yep at email@example.com
if you have any questions.