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UPCOMING LIVE SEMINARS
 






Comprehensive CRC Training

Upcoming Courses

Course #: SCRA0414
April 23-24, 2014
The Hub Meeting Center - CityView
Philadelphia, PA

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 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. 

Learning Objectives 

  • 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 

Who Should Attend
 

  • 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 
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., 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.
Jackie Stader, C.O.T., C.C.R.C.
 
 

Click here for complete trainer biographies

Course Outline 

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 

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

ACPE LogoBarnett 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 mail ACPE statements within three weeks of program completion.  ACPE# 0778-0000-13-029-L01-P. Released: 10/13. 

Hold this course at your company! 

For more information, contact Naila Ganatra at (215) 413-2471. 

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On-Demand GCP Refresher Training 

Too busy to attend a course? Our newly-released GCP eLearning course may be your solution!
For details on our scenario-based practical GCP application on-demand course, click here.


GCP for Investigators
 

Barnett’s scenario-based eLearning course is designed with the busy Principal Investigator in mind.  Based on real-life scenarios encountered by investigative site teams, this highly focused 7-module GCP training is designed to ensure comprehensive understanding of the key components of GCP.

For more details on this scenario-based eGCP program for investigators please click here. 


BARNETT CATALOG The Barnett Catalogue is your comprehensive guide to the myriad live, web, and custom training opportunities offered throughout the year. 

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Winter CatalogDownload Today!  

Blended Curriculum Path for the CRA, CRC, and Project Manager

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Web SeminarWEB SEMINARS

10-Week CRA & CRC Beginner Program  

Trial Master File (TMF) for Sponsors: Set-Up and Maintenance 

Use of Notes to File in Clinical Trial Essential Documentation 

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PublicationsPUBLICATIONS

2012 GCP Question & Answer Guide Print Edition 

2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

PAREXEL's Bio/Pharma R&D Statistical Sourcebook 2012/2013 (Hard Copy)