This 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. References and resources (including those available online) will be provided. Best practice techniques for site management will be provided. 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.
- Discuss the role the CRA plays in the drug development process
- State the “letter” and “spirit” of FDA regulations as well as ethical considerations pertinent to conducting clinical trials
- Identify and select qualified investigators and the investigative site
- Prepare for and conduct Site Selection/Qualification, Site Initiation, Routine Monitoring, and Study Close-Out Visits
- Manage and report adverse events (AEs)
- List study documentation requirements and standards for collecting and reporting clinical trial data
- Entry level Clinical Research Associates, Medical Research Associates and Clinical Scientists:
This is a practical, hands-on introduction to the job and how clinical monitoring tasks are performed. This course would be beneficial if you have been monitoring for less than one year, manage team members in this role, or for in-house CRA or project assistants who support CRA monitoring activities.
The course will be led by one of the following instructors:
Nikki Christison, B.S., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A.
Elizabeth Ronk Nelson, M.P.H.
Lily Romero, P.A., C.C.R.C.
Jackie Stader, C.O.T., C.C.R.C
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Overview of Drug Development and 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
Day 2: 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 & Process: FDA and ICH requirements; the role of the monitor in assuring appropriate consent
- Investigator’s Meetings & Study Initiation Visits: Purpose, preparation, and documentation
- Managing & Reporting Adverse Events: Terminology and examples; investigator and sponsor reporting requirements
- Investigational Product Accountability & Essential Documents: Regulatory and subject Documents;drug storage, documentation, and accountability requirements
Day 3: 8:30a.m. – 5:00 p.m.
- Routine Monitoring Visits & 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: Paper-based 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
- 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
Registration 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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-12-045-L01-P. Released: 7/12.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.