Take advantage of our $1507.50 price by registering early!
* After Friday, March 8, 2019, costs are $1687.50.
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.
- 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
- Prepare your site for sponsor audits and FDA
- Identify strategies for issues
management include root cause analysis and corrective and preventive
- 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
- Clinical Research Associates who are
interested in gaining a better understanding of the CRC and Investigator
The course will be led by one of the following
Marla Hoelle, R.N., B.S.N., C.C.R.A., P.M.P.
Gary B. Freeman, M.S.
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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
- 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;
- 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
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
- Budgets: Development of study budgets
- Time Management and Prioritization: Simulation exercise
- Review of Select Essential/Study Documents
- Review of a Protocol
- Adverse Events/Serious Adverse
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
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.
this course at your company! For more information, contact Naila Ganatra at +1