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Tuesday, December 11, 2018
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GCP: ICH Good Clinical Practice (ICH-GCP) (GCP001)

Certification Training CPD Accredited TrainingCredits: 3 CPD Credits
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $145.00

BioPharma Institute LogoTraining Program: GCP: 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.

Many regulatory changes are happening in the pharmaceutical industry. Those who are particularly affected are individuals involved in research. When carrying out research duties, there is always the risk of breaching ethical codes and/or compromising the quality of generated data. Critical to ensuring credible, high-quality data and ethical research is an understanding of the principles and background involved in Good Clinical Practice. This online course discusses the structure and key principles of ICH GCP and provides a broad framework in which to apply the standards of Good Clinical Practice through the use of actual practitioner experience and accounts.

The class covers topics such as informed consent, investigator responsibilities, documentation, teamwork, ICH GCP, harmonization, monitor responsibilities, and a key point summary at the end.

Once all course requirements have been satisfied, a Certificate of Completion is immediately available. Course takers can attempt the final assessment any number of times, as needed, in order to achieve a passing grade.

Benefits of Getting Certified at BioPharma Institute

By employing advanced e-learning training techniques, and coupling them with new automated tracking systems, the BioPharma Institute provides professionally designed online courses which are effective at training, and assist those interested with advancing their careers. The BioPharma Institute also assists companies through maintaining training records, the education of their employees, and assisting them with improving their overall quality of service. By coupling new automated tracking systems with proven and advanced e-learning training techniques, the BioPharma Institute can do for you and your company what we have done for numerous companies – both abroad and within the USA. We can assist in the maintaining of training records, the education of your employees, and with an overall improvement in the quality of service you offer.

Have Questions?

Should you have any particular question about this course, you can call us at (888) 424-6576 or send us an email at support@biopharmainstitute.com for more information.


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


Clinical Trials Monitoring Professional Certification Program: GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensures the wel … Learn more

Clinical Trials Management (US & EU) Professional Certification Program: This online professional certification program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates and coordinators with the desire to grow … Learn more

Obtaining Approval for Clinical Trials in US & EU Professional Certification Program: Clinical Trials Management (US & EU) Professional Certification Assures Employee Compliance of GCP Standards This professional certification program is designed for regulatory affairs managers, project 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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