Clinical Trials at UC Davis Health System

Clinical Trials at UC Davis Health System

 

 As part of the mission of the Clinical and Translational Sciences Center (http://www.ucdmc.ucdavis.edu/ctsc/) the Clinical Trials Resource Group  offers assistance with monitoring  and quality assurance to all investigator-initiated studies.  This program helps ensure compliance with FDA, GCP, and IRB regulations, and UC Davis Health System SOPs and P&Ps as related to clinical research. 

Particiption in this program is voluntary.

The activities offered aim to provide a proactive (rather than “for cause”) regulatory assessment; this assessment should be viewed as educational.  Please see the options for quality assurance oversight  (Level I = moderate risk studies ;  Level II =high risk studies).

The program is provided at no cost for unfunded studies.  For further information or to schedule an appointment to meet with the clinical research quality assurance program staff, please contact Denise Owensby  at 916-703-9191 or email denise.owensby@ucdmc.ucdavis.edu

Download the full text of Monitoring and Quality Assurance Program Description

 

Level I (Moderate Risk)

Investigator-initiated studies not including  drug/device       

Level II (High Risk)

Investigator-initiated studies with investigational (new or approved)  drug/device

Study Initiation visit

First monitoring visit scheduled after 2 subjects are enrolled (or within 6 months of first subject enrolled (whichever comes first).

Verify that:

  • Investigator follows approved protocol and approved amendments
  • Study site is maintaining all essential documents
  • Written informed consent was obtained before each subject's participation in the trial [100% of study subjects)
  • Study is enrolling only eligible subjects [100% of study subjects]
  • Source documents and other trial related records are accurate, complete, current, and maintained [100% first 2 subjects; 10% random sample remaining subjects]
  • Investigational product disposition and documentation [100% first 2 subjects; 10% random sample remaining subjects]
  • Documentation of dosing and/or therapy [100% first 2 subjects; 10% random sample remaining subjects]
  • Documentation and timely reporting of adverse events
  • Documentation and reporting of protocol deviations
  • Investigator provides all the required reports, notifications, applications, and submissions
  • Documentation of screen failures, subject withdrawals, exited subjects, etc.

Report is provided for the investigator of any deviations from the protocol, SOPs, GCP, and applicable regulatory requirements

Includes all items listed in Level I plus:

Verify that:

  • Accuracy and completeness of the Case Report Form data entries against source documents [% of patients to be determined on individual study basis]
  • Inform the investigator of any CRF data entry errors, omissions, or illegibility and ensure that appropriate corrections, additions or deletions are made, explained, initialed, and dated by authorized study staff
  • Resolution of any queries from previous monitoring visits