Archive: Essential Documentation in Clinical Trials at Research Sites
Jan 25, 2021, 20:23 PM
Course Id :
20682
Barnett Code :
BI13867
Date :
April 14, 2020
Conf Date :
Apr 14, 2020, 09:00 AM
Price :
735.00
Site License Price :
1735.00
Essential documentation serves to demonstrate the compliance of the investigator, sponsor and monitor, and IRB with the standards of GCP, best practice, and all applicable regulatory requirements. This course will discuss various types of essential documentation, subject specific and non-subject specific, for both drug and device trial research sites. The course will help define what should be maintained at a research site to promote adequate and accurate documentation of site, monitor, and IRB performance.
- Define clinical research essential documentation
- Examine the structure of the quality assurance/quality control relationship
- Discuss essential documentation for drug vs. device vs. combination products
- Prepare for regulatory inspection: Proactive and reactive use of essential documentation
- Clinical Research Coordinators
- Principal Investigators
- Research Site Managers
- Clinical Research Associates
- Quality Assurance Personnel
- Project Managers
- Clinical Research Associate Managers
Marla Hoelle, BSN, RN, CCRA, ACRP-PM, PMP
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Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.
Sort order :
2020041400000000
jobfunctions :
- Clinical Operations & Trial Management
- Clinical Quality Assurance
- Clinical Research Associate
- Clinical Research Coordinator
- Clinical Research Investigator
- Drug Safety
- Nursing
- Project Manager
- Study Site Compliance
- Training
series :
- Clinical Trials & Translational Medicine
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