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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: 12 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

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

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 12-month period. 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.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique ID code found on the certificate. Professional certification programs issue a digital badge to verify training and document the achievement. These digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.


  • 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


  • 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.

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

Price: $995.00.00 (USD) | Learn more

Benefits of Being Certified from Biopharma Institute: Throughout many of our online training programs students will be engaging in active learning through the use of interactive eLearning modules validated by 3rd party organizations for relevancy and regulatory content. The courses are developed by subject matter experts (SMEs) to promote the retaining of key knowledge. They offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity for the clinical research, pharmaceutical, and medical device industries.

Group Training for Employees: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training; Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Certificate of completion is instantly available once requirements have been fulfilled.
Verification of training:Certificates verifiable online with digital badges issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.

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