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Principal Investigator Training: Roles and Responsibilities November 2011

Nov 17, 2011
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Course Description

The roles and responsibilities of the Principal Investigator (PI) are essential for quality data and regulatory compliant clinical trials, but the PI remains an under-trained position in the industry. Because of the critical role the PI plays during a clinical trial, there is debate within the industry of mandatory certification for the PI and/or site accreditation. Documentation of industry training is essential. This web seminar reviews the clinical trial core competencies required for the Principal Investigator in accordance with the federal regulations, ICH GCP guidelines, and industry best practices.

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Learning Objectives

  • Recognize GCPs and the responsibilities of the Principal Investigator
  • Examine protocol content
  • Identify essential documents and the regulatory binder
  • Define source documentation
  • Examine informed consent and HIPAA authorization
  • Examine sponsor visits and reports
  • Explain investigational product management
  • Define safety reporting and Adverse Event documentation
  • Discuss FDA audits
  • Apply tools and resources

Who Should Attend

  • Physicians and others interested in getting involved in research
  • Experienced PIs or Site Personnel looking to take an industry investigator certification exam

Instructor

Gary B. Freeman, M.S., C.C.R.A., C.C.R.T. 

Click here for complete trainer biographies 

Course Length Time

3 hours; 12:00 - 3:00 p.m. Eastern

Course Dates

November 17, 2011

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. 


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Live SeminarLIVE SEMINARS

Monitoring Clinical Drug Studies: Intermediate 

Informed Consent Content & Process Requirements for Biobanking Studies 

Auditing Techniques for Clinical Research Professionals 


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 

10-Week Clinical Research Associate (CRA) On-Boarding Program  


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)