Length of Course: Approximate time to complete this course is 3 hour(s).
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
Training Program: GCP: ICH Good Clinical Practice (ICH-GCP)
Training Provided By: BioPharma Institute
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.
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.
The GCP: ICH Good Clinical Practice (ICH-GCP) course is found in the following professional certification program(s):
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.
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.
All Courses in the Clinical Trials Management and Monitoring Catalog:
|GCP: ICH Good Clinical Practice (ICH-GCP): 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 bre ... Learn more|
|GCP: Clinical Trial Preparation and Design: Worldwide expenditure by pharmaceutical companies on research and development is continually increasing. In the production of a new drug, most of the financial investment is allocated to clinical trials. It is ... Learn more|
|GCP: Clinical Trials and Drug Development: This online course teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials is outlined. The ... Learn more|
|GCP: Clinical Trial Monitoring: Site Evaluation and Set-up: Site evaluation and the set-up's purpose is to ensure that the site is fully prepared for the conduct of the clinical trial, facilitates to conduct the study, has adequate time and appropriately qualified staff ... Learn more|
|GCP: Clinical Trial Monitoring - Documentation and Closure: Once the initiation of a trial begins, the CRA (clinical research associate) has a crucial role which is to monitor the conduct of the trial, as well as the recorded data's integrity. This online course will fa ... Learn more|
|GCP: Preparing for an Audit or Inspection: In order to ensure compliance with GCP (Good Clinical Practice), clinical trial sites of investigators and sponsors are subject to rigorous inspection by regulatory agencies. In this course, United States and E ... Learn more|
|GCP: Application Process to Conduct FDA-regulated Clinical Trials in USA: The IND (Investigational New Drug) Application is a submission through which the sponsor seeks approval from the FDA (Food And Drug Administration) to conduct clinical studies with an investigational drug. This ... Learn more|
|GCP: How to Obtain Approval to Conduct Clinical Trials in the EU: Before each phase of clinical development, approval must be sought and gained for any sponsor desiring to conduct investigational drug clinical studies in the European Union. This online course enlightens regul ... Learn more|
Online Training: The Benefits of eLearning
- Immediate access to training: Instructions, username, 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 courses: 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
- Verification of training: Certificates can be verified online, and electronic badges are issued for all Professional Certification programs
- Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
- Purchase orders (POs) accepted: If POs are required, request an invoice to start the procurement process
- Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems
- Secure and safe access: Website and LMS offer an encrypted connection with firewall protection and daily scans for optimal level of security and performance
- Career advancement: Professional certifications could be helpful for those seeking new careers or transitioning to different positions within their organization
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.