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:

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM, P.M.P.

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 Ronk Nelson, M.P.H.

Click here for complete trainer biographies

Course Outline

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

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

Day 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

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
Monitoring Visit Priorities Activity

Registration Fees

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.

Click here for our seminar cancellation policy

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#: 0778-0000-17-086-L01-P. Released: 2/17.

The New Jersey State Nurses Association is accredited by the ANCC Commission on Accreditation of the American Nurses Association as an approver of continuing education for nursing. As an accredited body, NJSNA has approved this program for: Contact hours competed: 22.0 Approval Number: 7893-1/19-21

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