Course Description

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. 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.

Learning Objectives

• 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

Who Should Attend

• 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

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A.,T.I.A.C.R.

Sonja Cooper, Ph.D., M.B.A.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Outline

Day One

• 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

Day Two

• 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 reporting requirements
• Investigational Product Accountability and Essential Documents: Regulatory and subject Documents; drug storage, documentation, and accountability requirements

Day Three

• 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

Interactive Activities

• 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

Registration Fees

Accreditation Information

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#: 0778-0000-23-029-L99-P. Released: 3/23.  

                     Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.