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 drug 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, and all of the activities, site visits, and documentation that occur along the way. Finally, site audits and inspections will be reviewed, with an emphasis on the CRC’s role in that process.
- Discuss the CRC role in the development of new drugs
- Describe “letter” and the “spirit” of FDA regulations, ICH guidelines, and ethical considerations pertinent to conducting clinical trials
- Prepare for all sponsor site visits
- Develop strategies for recruiting and retaining study subjects
- Discuss the informed consent process
- Review the reporting requirements of adverse events
- Employ study documentation requirements and standards for collecting and reporting clinical trials data
- Develop strategies for preparing, implementing, and managing clinical studies, including budget considerations
- Prepare your site for an FDA inspection
- Identify strategies for issues management include root cause analysis and corrective and preventive action plans
- Clinical Research Coordinators (CRCs) with limited experience in managing industry-sponsored investigational drug studies
- Experienced Coordinators seeking a greater understanding of federal regulations and ICH requirements and to enhance their skills to more efficiently and effectively manage their studies
- CRAs who are interested in gaining a better understanding of the CRC and investigator role
The course will be led by one of the following instructors:
Nikki Christison, B.S., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A. .
Beth D. Harper, B.S., M.B.A
Elizabeth Ronk Nelson, M.P.H
Lily Romero, P.A., C.C.R.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Overview of Drug Development and Good Clinical Practice: Terminology; phases of drug development 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 2: 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
- Drug Accountability: Documentation, storage requirements and CRC responsibilities
- Close-Out Visits: Preparation and activities
- FDA Audits: Mechanics of an FDA inspection; common audit findings
- 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 Events Exercise
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.
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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 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# 0778-0000-13-029-L01-P. Released: 10/13.
This continuing nursing education activity was approved by the New Jersey State Nurses Association, an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation.
Approval Number: 7489-2/14-16. 14 Contact Hours
Participants will receive 14 hours of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.