fundamental “how to” and “why” workshop focuses on current regulatory
requirements to promote successful monitoring of studies. Participants will
learn about the role and responsibilities of the monitor, the investigator, and
the IRB from pre-study through post study. Best practice techniques for site
management will be provided, and activities such as case scenarios and
simulation exercises reviewing an informed consent document, investigator study
file, subject case report forms, and source documents will reinforce learning
concepts. This is a practical, hands-on introduction to the job and how
clinical monitoring tasks are performed.
- Discuss the role the CRA plays in the drug development
- State the “letter” and “spirit” of
FDA regulations as well as ethical considerations pertinent to conducting
- Identify and select qualified
investigators and the investigative site
- Prepare for and conduct Site
Selection/Qualification, Site Initiation, Routine Monitoring, and Study
- Manage and report adverse events
- List study documentation
requirements and standards for collecting and reporting clinical trial data
- This course is beneficial if you have been monitoring
for less than one year, or if you are an in-house CRA or project assistant
who supports CRA monitoring activities
The course will be led by one of the following
Gary B. Freeman, M.S.
Marla Hoelle, R.N., B.S.N.,
Lily Romero, P.A., C.C.R.C.
Elizabeth Ronk Nelson,
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Day One: 8:30 a.m. – 5:00 p.m.
- Overview of Drug Development and ICH GCP: Terminology; the drug approval process
- The Clinical Research Team: Roles and responsibilities
- The Site Selection Process and Site Qualification Visits: Locating, screening, and evaluating prospective
investigators; selection criteria
Two: 8:30 a.m. – 5:00 p.m.
- IRBs/IECs and the Protocol Approval Process: Membership requirements; documents and activities
- Study Subject Recruitment, and the Informed Consent Document and
Process: FDA and ICH requirements; the role of the monitor in
assuring appropriate consent
- Investigator’s Meetings and Study Initiation Visits: Purpose, preparation, and documentation
- Managing and Reporting Adverse Events: Terminology and examples; investigator and sponsor
- Investigational Product Accountability and Essential Documents: Regulatory and subject Documents; drug storage, documentation,
and accountability requirements
Three: 8:30 a.m. – 5:00 p.m.
- Routine Monitoring Visits and Source Data Verification: Preparing for, during the visit, and post visit
activities; process for reviewing source documents and identifying discrepancies
- Clinical Data Management Overview, Trip Reports, and Study
Close-out Visits: Paperbased and electronic case report forms, queries,
and conducting close-out visits
- Monitoring Simulation Exercise: Regulatory Binder and Source Data Verification
- Basic Monitoring Skills – Hands-on Simulation Exercise
- Informed Consent Critique and
Selecting Clinical Sites
- Identifying, Classifying, and
Reporting Adverse Events
- Drug Accountability Case Studies and
Calculating IP Compliance
- Case Scenarios: Site Selection,
Study Initiation Visits, and Routine Monitoring Visits
- Monitoring Visit Priorities Activity
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
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Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 22.5 hours (2.25 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-17-086-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1