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.
- Describe the role of the FDA in the drug development process
- Define GCP
- Identify qualified investigators and the investigative site
- Describe the informed consent process
- Prepare for pre-study visits
- Conduct study initiation visits
- Prepare for monitoring visits
- Describe adverse events/serious adverse events and reporting requirements
- Discuss investigational product accountability
- Describe essential document management
- Complete study close-out visits
- Identify, report, and manage site performance and study related issues
- Describe the inspection/audit purpose and process
- Entry level Clinical Research Associates, Medical Research Associates and Clinical Scientists: This is a practical, hands-on introduction to the job and how clinical 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 are in-house CRA or project assistant who supports CRA monitoring activities.
The course will be led by one of the following instructors:
Nikki Christison, B.S.
Karen Gilbert, 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
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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: Locating, screening, and evaluating prospective investigators; selection criteria
- Site Qualification Visits: Preparation and activities
- IRBs/IECs and the Protocol Approval Process: Membership requirements; documents and activities
Day 2: 8:30 a.m. – 5:00 p.m.
- Informed Consent Documents and Process: FDA and ICH requirements; the role of the monitor in assuring appropriate consent
- Study Initiation Visit: Preparation and activities
- Essential Documents: Regulatory and subject documents; FDA and ICH requirements
- Monitoring Visits: Preparing for, during the visit, and post visit activities
- Data Management: Paper based and electronic case report forms, queries
Day 3: 8:30a.m. – 5:00 p.m.
- Managing and Reporting Adverse Events: Terminology and examples; investigator and sponsor reporting requirements
- Study Termination Visits and Drug Accountability: Preparation and activities; drug storage, documentation, and accountability requirements
- Regulatory Authority/FDA Inspections and Sponsor Audits
- Monitoring Simulation Exercise: Case study; identifying and resolving discrepancies
- Basic Monitoring Skills – Hands-on Simulation Exercise
- Informed Consent Critique
- Selecting Clinical Sites
- Adverse Event Scenarios
- Case Scenarios: Study Initiation Visits, Study Close-Out Visits
- Role Playing
- Prioritizing Exercises (Preparing, During, and Post Monitoring Visits)
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 Elizabeth Andrews 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.