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Home » GCP: ICH Good Clinical Practice (ICH-GCP), An Abridged Course

GCP: ICH Good Clinical Practice (ICH-GCP), An Abridged Course (GCP00)

Certification Training
 
Rated 4.45/5
11 reviews
Method of Training: Online / Self-paced eLearning.
Credit Hours: 0.5 credits.
Duration: ~30 minutes.
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.

THIS IS A FREE COURSE.
Enroll today and see why the Biopharma Institute is used by pharmaceutical and biotechnology companies around the world.

Demonstrate your dedication to job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GCP: ICH Good Clinical Practice (ICH-GCP), An Abridged Course
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute Reviews

The pharmaceutical industry is currently undergoing a large number of regulatory changes. Individuals that are involved in research will be directly affected. As we carry out our duties there is always the risk of compromising the data quality that we generate and the risk of breaching the various codes of ethics. An understanding of the principles and background of Good Clinical Practice are critical to ensuring credible data, high quality, and ethical research. This abridged online course provides a demonstration of the GCP: ICH Good Clinical Practice (ICH-GCP).

Course content includes a brief introduction to ICH GCP guidelines, sponsor's responsibilities and a final assessment. The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 80% or better is required to immediately receive the certificate of completion in a PDF format.

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.

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 passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.


COURSE OUTLINE:


This abridged online course provides a demonstration of the full length course, titled 'GCP: ICH Good Clinical Practice (ICH-GCP)'.

Module Overview:
- Learning Expectations

Sponsor Responsibilities:

Quality Management System: Risk-based Approach
- Critical Process and Data Identification
- Risk Identification
- Risk Evaluation
- Risk Control
- Quality Tolerance Limits
- Risk Communication
- Risk Review
- Risk Reporting

Trial Management
- QA and QC
- Delegation to CRO
- Medical Expertise
- Multicenter Trials
- IDMC

Regulatory Submissions and Confirmation of IRB/IEC Review

Investigational Products
- Information in Invetigators Brochure
- Manufacture, Packaging, and Labeling
- Coding
- Supply and Handling
- Stability

Quick Check

Risk-based Monitoring
- Variable approach
- On-site vs Centralized Monitoring
- Use of Centralized Monitoring
- Review of Data

COURSE OBJECTIVES:


Students completing this course should achieve an understanding for how the BioPharma Institute courses are delivered, the requirements for accomplishing training certifications from the BioPharma Institute, and how to access the certificate of completion, once all requirements are satisfied.

Full List of Programs in the Clinical Trials Management and Monitoring Catalog:



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

Obtaining Approval for Clinical Trials in US & EU Professional Certification Program: This professional certification program is designed for regulatory affairs managers, project managers, or clinical research associates and coordinators with desire to grow their career into these positions. Cou ... 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

GCP: ICH Good Clinical Practice (ICH-GCP), An Abridged Course: The pharmaceutical industry is currently undergoing a large number of regulatory changes. Individuals that are involved in research will be directly affected. As we carry out our duties there is always the risk ... Learn more

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 are 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 for professional certification programs for 180 days
  • Flexible final assessments: Assessment testing include multiple-choice questions and can be taken repeatedly until a passing score is achieved
  • Direct access to certificates: Certificate of completion is instantly available once course requirements have been fulfilled
  • Verification of training: Certificates can be verified online, and digital badges are issued for all Professional Certification programs
  • Tuition reimbursement: Some employers may reimburse for training expenses; check on your company's requirements
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option
  • Purchase orders (POs) accepted: If a PO is required by your company, 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 provide an encrypted connection with firewall protection and daily scans for optimal level of security and performance
  • Career advancement: Professional certifications help demonstrate your interest and dedication to job performance, and may be helpful for those seeking a new career or transitioning to different positions within their organization

Contact Us:

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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