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Home » GCP Training: ICH E6(R2) - (Refresher Training for Novice)

GCP Training: ICH E6(R2) - (Refresher Training for Novice)

Certification Training
 
Rated 4.33/5
3 reviews
Program/Course ID: CP002a
Enrollment Period: 6 months.
Average Learning Time: ~75 minutes.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / 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.
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: GCP Training: ICH E6(R2) - (Refresher Training for Novice)
Training Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

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

Description:
Biopharma Institute Reviews

This GCP Training: ICH E6(R2) course covers key components of the GCP requirements for clinical trials, found in ICH E6(R2), and relates to the roles and responsibilities of the investigator, sponsor, and other stakeholders. The course covers an introduction to GCP; reviews major regulatory agencies in the United States, European Union, and Japan; describes essential documentation methods; and moves on to cover good documentation practices (GDocP), including ALCOA-C.

Recommended for those new to working with GCP such as clinical research professionals who are in need of a more comprehensive GCP training to better understand the guidelines and to continue growing their career working on clinical trials.

This ICH E6 (R2) GCP Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

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.

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.


Outline:


GCP Overview
  • What is GCP
  • GCP Resources
  • What is ICH
  • What is E6
  • Purposes of GCP
  • Who Does GCP Affect?
  • ICH E6 Principles
Major Regulatory Authorities
  • Global Health Authorities
  • The EU and GCP
  • Transition between Directive and Regulation
  • The Corpus of GCP in the EU
  • The US and GCP
  • The Role of the FDA
  • Applicable Regulations in the US
  • Japan and GCP
GCP Essential Documentation
  • The Clinical Trials Protocol
  • Protocol Amendments vs Deviations
  • Investigator's Brochure
  • Essential Documents Definition
  • Trial Master File (TMF)
  • Sponsor & Investigator Regulatory Binders/TMF
  • A Note about Sponsors and Records
Sponsor Responsibilities
  • General Qualifications
  • Sponsor General Responsibilities
  • The Sponsor's Representative: The Monitor
  • Audit vs. Inspection
  • ICH E6(R2) and QRM
  • Implementation of a QRM Good Clinical Practice
Investigator Responsibilities
  • General Qualifications
  • Investigator Agreements and Responsibilities
  • Pre-Study Responsibilities
  • Responsibilities During the Study Conduct
  • Records and Reports
  • Termination or Suspension
  • Lack of Oversight
Ethics Committee and ICF
  • What are IRBs/ECs?
  • IRB/EC Responsibilities
  • Types of Review and Decisions
  • What is Informed Consent?
  • Informed Consent Process
  • Vulnerable Subjects
  • Emergency Consent
  • Elements of Consent
  • Stakeholder Responsibilities
  • Informed Consent Tips from Regulators
  • Informed Consent Amendments
  • Common Informed Consent Deficiencies
ALCOA-C and Good Documentation Practices
  • Why are Good Documentation Practices Important?
  • ALCOA / ALCOA-C / ALCOACCEA?
  • A is for Attributable
  • L is for Legible
  • C is for Contemporaneous
  • O is for Original
  • Certified Copies, Paper and Electronic
  • A is for Accurate
  • C is for Complete
Question Post Assessment

Objectives:


Learning Objectives:
  • Apply critical thinking techniques for effective implementation of the global Good Clinical Practice Guideline, ICH E6(R2).
  • Discover how the ICH global guideline affects your role.
  • Reflect on challenges and opportunities in implementing the guideline.
  • Identify practical applications of the guideline in your work processes including identifying methods to assess quality systems and documentation.

Length: 75 minutes run time plus additional time to complete activities and post assessment.

Audience: All clinical research professionals, particularly those with less experience, who have previously trained on GCP, but desire or require a refresher training providing more detail for the individual roles responsibilities as required by GCP. It is a perfect course for renewal training.

Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing 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.
  • Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • 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.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.