Comprehensive CRC Training

EARLY REGISTRATION
Course #: SCRB1018
October 2-3, 2018 | Boston, MA
8:30 AM - 5:00 PM Eastern
Metro Meeting Centers - Boston
Take advantage of our $1675.00 price by registering early!
* After Friday, August 31, 2018, costs are $1875.00.
*
$1,675.00

Take advantage of our $1675.00 price by registering early!
* After Friday, August 31, 2018, costs are $1875.00.

Course Description

This course provides an in-depth survey of the roles and responsibilities of the investigator site Clinical Research Coordinator (CRC). The course begins with an overview of the investigational product development process and regulatory environment in which the CRC operates. From there, critical CRC responsibilities will be discussed, including patient recruitment and retention, informed consent, adverse event reporting, and investigational product accountability. The CRC’s role at the site will be explored, from study start-up through site close-out visits, including documentation that occurs along the way. Finally, the role the CRC plays in both sponsor audits and FDA inspections will be reviewed, along with how to effectively prepare for an audit or inspection.

Learning Objectives

  • Describe the investigational product development process (drug and medical device)
  • Prepare for all sponsor site visits
  • Develop strategies for recruiting and retaining study subjects
  • Define the informed consent process and the elements of the informed consent
  • Review the reporting requirements of adverse events for both drug and medical devices
  • Employ study documentation requirements and standards for collecting and reporting clinical trials data and Investigational product
  • Develop strategies for preparing, implementing, and managing clinical studies, including budget considerations
  • Prepare your site for sponsor audits and FDA inspection
  • Identify strategies for issues management include root cause analysis and corrective and preventive action plans

Who Should Attend

  • Clinical Research Coordinators with limited experience in managing industry-sponsored investigational drug studies
  • Experienced Coordinators seeking to enhance their skills to more efficiently and effectively manage their studies
  • Clinical Research Associates who are interested in gaining a better understanding of the CRC and Investigator roles

Instructor

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

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

Gary B. Freeman, M.S.

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • Overview of the Investigational Product Development: Terminology; phases of drug development classification of medical devices, and introduction to GCP
  • The Clinical Research Team: Roles and responsibilities; appropriate delegation of investigator responsibilities
  • The Site Selection Process: Criteria for site selection; planning and preparing for the site qualification visit
  • IRBs and the Protocol Approval Process: IRB membership and operational requirements; sponsor-site-IRB relationships
  • Study Start-up and Study Initiation Visits: Preparations and activities
  • Subject Recruitment and the Informed Consent Process: Advertising guidelines, strategies for successful recruitment, documentation requirements; execution considerations

Day Two: 8:30 a.m. – 5:00 p.m.

  • Study Implementation and Study Documents: Regulatory files, source documents and case report forms; records retention
  • Monitoring Visits: Preparation and activities; simulation exercise
  • Managing and Reporting Adverse Events: Definitions and reporting requirements; differences in various sponsor policies
  • Investigational Product Accountability: Documentation, storage requirements and CRC responsibilities
  • Close-Out Visits: Preparation and activities
  • Sponsor Audits and FDA Inspections: Mechanics of a Sponsor Audit and FDA inspection; common FDA inspection findings
  • Budgets: Development of study budgets
  • Time Management and Prioritization: Simulation exercise

Interactive Activities

  • Review of Select Essential/Study Documents
  • Review of a Protocol
  • Adverse Events/Serious Adverse Events Exercise

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 15 hours (1.5 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#: 0778-0000-16-030-L01-P. Released: 10/16.

 

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