Monitoring and Quality Assurance
Sponsor-Investigator Responsibilities for Study Monitoring
In accordance with the ICH GCP E6 , the purposes of trial monitoring are to verify that:
(a) The rights and well-being of human subjects are protected.
(b) The reported trial data are accurate, complete, and verifiable from source documents.
(c) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).
The Sponsor (or Sponsor-Investigator) is responsible for selection of qualified study monitors and ensuring that the trials are adequately monitored throughout the life of the trial. At UC Davis, Clinical Trial Resource Group may be contracted to provide routine study monitoring. Office of Compliance and Integrity provides periodic random and for cause audits.
Clinical Trials Resource Group Services
We offer monitoring, quality assurance and FDA audit preparedness services to investigator-initiated and industry-initiated trials. Our program helps ensure compliance with FDA, GCP, and IRB regulations, as well as with UC Davis Health System SOPs and P&Ps as related to clinical research.
Participation 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. The program is provided at no cost for unfunded studies. Contact us for further information.
Study Initiation visit
First monitoring visit scheduled after 2 subjects are enrolled (or within 6 months of first subject enrolled (whichever comes first).
- 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:
- 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