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Home » Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

Certification Training
 
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Program/Course ID: CP019a
Enrollment Period: 6 months.
Average Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online, Asynchronous, Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Credit Hours: 2 credits.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $199.00 USD  

Document your dedication to quality, compliance, safety, and job performance by earning a training certification.

Training Program: Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
Biopharma Institute ReviewsICH E8(R1) is the umbrella guideline that maps to all the ICH "E" family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives. The key purpose is to design quality into clinical trials, which is supported by the establishment of an appropriate framework for the identification and review of Critical to Quality factors at the time of design and planning of the study, and throughout its conduct, analysis, and reporting.

Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 6-month period, or a 12-month period for professional certification programs. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity period for employee compliance training would be determined by those responsible for managing quality assurance.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment any number of times, as needed, to achieve a passing score. The certificate of completion is instantaneously launched and made available to the student in a PDF format upon completion.

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Outline:


  • 1. Background for the ICH E8 Revision
  • a. Background
  • b. Objectives of E8 Revision (Section 1)
  • c. GCP Renovation
  • d. GCP Renovation Paper Identified Gaps
  • e. Principles of Trial Design and Planning
  • f. Part 1 Summary

  • 2. Quality by Design and Critical to Quality in ICH E8(R1)
  • a. ICH E8(R1) -A Major Revision
  • b. Trial Designs & Types of Studies
  • c. Focus of Risk in ICH E8(R1)
  • d. RBQM Change Management
  • e. Primary Goals of ICH E8(R1)
  • f. Increased Focus on Electronic Data Sources
  • g. Focus of Risk in ICH E8(R1) (Section 3.1)
  • h. Quality By Design (QbD) in Clinical Trials - ICH E8(R1)
  • i. Considerations in Identifying Critical to Quality Factors (Section 7)
  • j. Critical Aspects of a Quality Approach to Study Design (Section 3.3)
  • k. Critical to Quality Factors (Section 3.2)
  • l. Part 2 Summary

  • 3. High-level Overview of ICH E8(R1)
  • a. ICH E8(R1) Table of Contents
  • b. ICH E8(R1) Overlying Theme
  • c. Scientific Approach (Section 2.2) Overview of ICH E8(R1)
  • d. Approach to Identifying the Critical to Quality Factors (Section 3.3)
  • e. Establishing a Culture that Supports Open Dialogue (Section 3.3.1)
  • f. Focusing on Activities Essential to the Study (Section 3.3.2)
  • g. Engaging Stakeholders in Study Design (Section 3.3.3) & Patient Input (Section 2.3)
  • h. Reviewing Critical to Quality Factors (Section 3.3.4)
  • i. Critical to Quality Factors in Operational Practice (Section 3.3.5)
  • j. Drug Development Planning (Section 4)
  • k. Design Elements and Data Sources for Clinical Studies (Section 5)
  • l. Rooted in the Protection of Participants
  • m. Study Conduct (Section 6.1)
  • n. Participant Safety during Study Conduct (Section 6.2)
  • o. Study Reporting (Section 6.3)
  • p. ICH E8(R1) Annex
  • q. Change Management is Key to Implementing
  • r. ICH E8 (and E6) Revisions - Goals and Conclusion

  • 4. Real-life Case Scenarios

  • 5. 10 Question Post Assessment

Objectives:


  • Recognize how ICH E8(R1), the Guideline for General Considerations for Clinical Studies, has changed organizational processes.
  • Apply the Guideline to key concepts in clinical trials.
  • Discuss implementation challenges and opportunities regarding the updates in the Guideline.


Audience: All clinical research personnel who want to understand a master international guideline to principles and practices that ensure protection of study participants and quality data.

Keywords:
GCP, good clinical practice, sponsor, site, monitor, coordinator, investigator, clinical research, clinical trial, clinical study, quality by design, QbD, fit for purpose, critical to quality, quality data, human subject protection, GCP Renovation, ICH, E8(R1)

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline is included in the following professional certification programs:



Professional Certification Program:

Clinical Research Coordinator (CRC) Professional Certification Program

Course ID: CRCPRO
Price: $995.00 (USD) | Learn more

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