Monitoring Visit Reports (MVRs) are essential documents that also serve many other functions - MVRs should not be a hassle or a formality. MVRs should eliminate the need for most monitoring tools as these reports are the monitoring tool. MVRs remove the need for long-winded explanations to others about a site visit. These documents help support the audit readiness of the sponsor/CRO monitor, as well as the institution/site. MVRs are the place to develop concerns, resolve issues, and measure if your resolutions are satisfactory.
This course presents design and writing techniques for “liquid report” planning and writing, using the report as a dynamic “living document” that harmonizes metrics, risk indicators, and action plans - and should be written by the time a monitor leaves the site or finishes the monitoring activity (e.g., remote monitoring). This course will teach you better ways to support timely high quality reports, rather than (or in addition to) traditional methods, such as annotated reports.
Attend this interactive live session and you will:
This course will be of benefit to anyone responsible for writing monitoring visit reports, supporting monitoring report writing practices, reviewing monitoring visit reports, and/or training monitors on report writing. This course will also be of value to anyone who needs to understand critical documentation requirements of the monitoring report process.
Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC). She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).