Apr 06, 2011
from 01:00 PM to 02:00 PM
|Contact Name||John Kelley|
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The Office of Clinical Trials is introducing a new educational series called “COMPLIANCE MATTERS”. The double entendre is intended: clinical trials compliance does matter, and we all need to remain informed of the latest issues or topics (i.e., “matters”) related to conducting clinical trials in a safe and sound manner. These informational/discussion sessions will be scheduled monthly and each will last a maximum of one hour. The intent is not necessarily to go into great detail as much as to ensure that compliance topics remain in everyone’s awareness; we can delve more deeply into specific issues that generate a particular interest. COMPLIANCE MATTERS schedules and topics will be on the OCT website under the “Training” link on the left hand side of the page. Registration for COMPLIANCE MATTERS is requested but not required. The registration link for all training classes is: http://cfx.research.unc.edu/res_classreg/browse.cfm
The first session is scheduled for April 6, from 1p – 2p in 1131 Bioinformatics. We will review FDA’s December 10, 2010 Draft Guidance on “Electronic Source Documentation in Clinical Investigations”, which states as its purpose, This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. This guidance is intended to ensure the reliability, quality, integrity, and traceability of electronic source data and source records maintained at the site for FDA inspection”.
For those who would like to review the draft guidance in advance, here is the link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM239052