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Friday, June 18, 2021
Home » GCP: An Introduction to Good Clinical Practices - Part 1

GCP: An Introduction to Good Clinical Practices - Part 1 (ELM-901)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.

Biopharma Institute LogoTraining Program: GCP: An Introduction to Good Clinical Practices - Part 1
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 ReviewsGood Clinical Practice (GCP) is an international ethical and scientific quality standard provided by International Council for Harmonisation (ICH) for the design, conduct, performance, monitoring, auditing, recording, analyzes and reporting of clinical trials that involve the participation of human subjects. This course explores the relevance of Good Clinical Practices (GCP) in clinical research and trial programs. It covers clinical professional roles, clinical trial methodology, study design, protocol preparation, patient monitoring, quality assurance, ethical / legal issues and much more.
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.


GCP: An Introduction to Good Clinical Practices - Part 1 course is included in the following Professional Certification Programs:



Good Clinical Practice for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more

COURSE OUTLINE:


Introduction
Overview
Learning Objectives
Who Should Take This Course?
Course Modules

Overview
What is GCP?
History of Ethical Guidelines
The Nuremberg Code
Declaration of Helsinki
The Belmont Report
International Guidelines for Biomedical Research Involving Human Subjects
The Principles of ICH-GCP - Part 1
The Principles of ICH-GCP - Part 2
Knowledge Check

Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
What is the IRB/IEC
Composition of the IRB/IEC
Major Responsibilities of the IRB/IEC
Working Procedures
Maintenance of Records
Knowledge Check

An Overview of Investigators Responsibilities
Who Can Be an Investigator?
Responsibilities: Resourcing
Responsibilities: Medical Care of Trial Subjects
Responsibilities: Ethical Approval
Responsibilities: Compliance with Protocol
Responsibilities: Investigational Medicinal Products (IMP)
Responsibilities: Randomization
Responsibilities: Records and Reports
Responsibilities: Safety Reporting
Responsibilities: General Responsibilities
Knowledge Check

Informed Consent
Informed Consent and its Importance
Informed Consent Process
Informed Consent Form
Revisions to Informed Consent
Knowledge Check

Conclusion


Final Assessment


Certification

COURSE OBJECTIVES:


Skill Level:
Intermediate

This training program has been developed to train employees with Intermediate Knowledge of Good Clinical Practices (cGCP).

Online Training: The Benefits of Remote Learning & 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 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.
  • 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.

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