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Saturday, January 19, 2019
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GCP: An Introduction to ICH Good Clinical Practice (ICH-GCP) (GCP01)

Certification Training Duration: 2 hours (the average time to complete the training program, including final assessments).
Credits Hours: 2
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

THIS COURSE IS CURRENTLY NOT AVAILABLE.
Contact the BioPharma Institute for more information.

BioPharma Institute LogoTraining Program: GCP: An Introduction to ICH Good Clinical Practice (ICH-GCP)
Training Provided By: BioPharma Institute
Website: https://www.biopharmainstitute.com

Availability: Immediately available upon ordering.

Description: Online training with immediate access upon enrollment. The pharmaceutical industry is undergoing many regulatory changes. Those of us involved in research are directly affected. When carrying out our duties there is a risk of compromising the quality of data we generate and of breaching ethical codes. An understanding of the background and the principles of Good Clinical Practice are critical to ensure ethical research, high quality and credible data. This online course describes the key principles and structure of ICH GCP and, by using actual practitioner experience and accounts, provides a broad framework in which to apply the standards of Good Clinical Practice.
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with >80% passing grade within a 90 day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Online Training Programs Include:

  • Immediate access to training: Instructions, user name, password and receipt of payment emailed instantly upon online enrollment
  • Optimized for learning: Courses include voice-overs, easy navigation, progress checks, and high-quality animations to increase retention of subject matter
  • Self-paced training: 24/7 access to individual courses for 90 days; and 180 days for professional certification programs
  • Flexible final assessments: Tests include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Documentation instantly available once course requirements have been fulfilled
  • Corporate reimbursements: Employers may pay for or reimburse employees for training. Purchase orders (POs) for both individual and group training are accepted
  • Corporate LMS solutions: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
  • Career advancement: Professional certifications may be helpful for those seeking new careers or transitioning to different positions within their organization


The GCP: An Introduction to ICH Good Clinical Practice (ICH-GCP) course is found in the following professional certification program(s):


Professional Designation in Clinical Trials Management: For Clinical Research Associates, Project Managers, and Clinical Managers. … Learn more

Professional Designation in Good Clinical Practice: For Clinical Research Associates, Project Managers, and Clinical Managers. … Learn more


COURSE OUTLINE:


Harmonization: The topics covered in this session map the development of ICH and the processes involved in establishing international standards and the technical requirements to ensure the safety, quality and efficacy of new medicines.

ICH GCP Guidelines: The topics covered in this session describe the principles and structure of ICH GCP and provide a broad context in which to apply the standards of good clinical practice.

Teamwork: This session examines the roles of the sponsor, investigator and monitor and the communication and interaction necessary to fulfill these obligations and conduct a successful trial.

Documentation: This session connects these key documents with the responsibilities of the investigator, sponsor, monitor and support team.

Investigator responsibilities: This session covers the main responsibilities of the investigator for the conduct of the clinical trial and explains how to ensure the accuracy, completeness, legibility and timeliness of data generated during the study.

Informed consent: This session focuses on the main requirements necessary to support an effective and efficient informed consent process.

Monitor responsibilities: This session explores the responsibilities of the monitor and provides insight into these key challenges.

Summary: Key point summary for all topics covered in This online course. Ideal for review, a refresher or consolidation of learning points.

COURSE OBJECTIVES:


Students completing this course should be able to: Understand the processes involved in establishing international standards and technical requirements for Good Clinical Practice. Describe the principles and structure of ICH GCP. Apply the main guidelines of Good Clinical Practice in the workplace. Explain the key responsibilities of the Sponsor, Investigator, Monitor and the Study Team in conducting a successful clinical trial. Understand the use of key documentation used in clinical trials. Demonstrate an understanding of the informed consent process in clinical trials.


For more information on the BioPharma Institute’s training programs, or to suggest a course, please complete the form located below. Alternatively, you may call toll free in the US: (888) 4-BIO-LRN, international callers can dial (201) 301-8370, or email Support@BioPharmaInstitute.com.

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