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"Conducting Clinical Trials A-Z"
Ongoing Review,
Monitoring, and Quality Assurance
Continuation Review
(CR)- Federal regulations require all approved
trials be re-reviewed by the respective IRB at least once a year.
Continuation review by the IRB requires the investigator to complete and
return a continuation review report provided by the Office of Research
Integrity. NOTE: New adverse event and unexpected problem reporting
policy will affect CR (see adverse event section and ORI link above for
guidance).
Continuation
Review Slide Presentation
(PDF)
Sponsor
Monitoring-
Regulations
require that clinical trials involving human subjects be monitored. The
monitoring process serves to:
-
Verify protection of the
subject’s rights and welfare
-
Verify data is accurate,
complete and verifiable from the source documents
-
Promote and ensure
compliance with applicable regulatory requirements
-
Review all IRB
correspondence TIP: use serial numbers to track correspondence to and
from the IRB to provide a clear paper trail.
-
Ensure adherence to the
protocol and recording/reporting of deviations
-
Verify study drug
dispensation and accountability
-
Provide support and
guidance to staff
-
Ensure site has adequate
study supplies
A monitor (may be
called a Clinical Research Associate or CRA) is a person employed or
contracted by the sponsor or CRO to provide oversight for study related
activities and perform the study monitoring function. Types of
monitoring visits will likely include a study-initiation visit, periodic
monitoring visits, and study close-out visit.
The frequency,
length and complexity of the monitoring visits will vary with the
trial. Considerations when scheduling and preparing for and following
monitoring visits:
-
Complete study records
-
Provide a dedicated work
area
-
Consider confidentiality
of materials from other studies
-
Have source documents,
logs, medical records and CRFs, and regulatory files available as
requested
-
Allow for photocopies of
required documents
-
Ensure drug supplies are
ready for inspection (notify IDS if applicable)
-
Plan for coordinator and
investigator to spend time with monitor and review monitor’s report
-
Strive to correct all
data queries promptly and resolve outstanding items prior to the next
monitor visit
-
Rely on the monitor for questions and concerns between visits.
-
Maintain records of all
written and phone correspondence. TIP: keep a phone log book to record
phone conversations. Keep copies of emails other written correspondence.
Sample Phone
Log (PDF)
Data Safety Monitoring (DSM)-
DSM is another layer of oversight to ensure the safety of participants and the
validity and integrity of the data. A Data Safety Monitoring Board (DSMB) is an
independent group of reviewers that assess at intervals the progress of the trial
including safety data, efficacy endpoints and make recommendations to the
sponsor whether to continue, modify or stop the trial. Module 6 provides links
to guidelines on DSMB establishment and requirements.
Quality
Assurance (QA) –
Quality assurance
can transcend study specific areas to the site performance as a whole.
The site selection checklist above covers initial evaluation, however
implementing a regular QA program internally can improve and streamline
your operation and serves to credential your site.
Elements of a QA
program may include position descriptions, Standard Operating Procedures
(SOPs), Training/Certifications of staff and investigators, customer
feedback evaluations, and quality control tools.
For sample site
operation SOPs, contact UKCRO Nurse Manager Mary Wethington, RN, at
323-1751 or
mary.wethington@uky.edu.
ORI Quality Improvement
Program –
The ORI has developed a Quality
Improvement Program (QIP) complete with education based
resources, tools and a web-based self-assessment tool for use
by UK investigators.
For more information contact Judi Kuhl at 257-9764 or
judi.kuhl@uky.edu or review the following PowerPoint Presentation on
the QIP.
Building on Quality Improvement for Human Subject Protection (PDF)
 
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