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.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.
PRICE: USD $199.00
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon ordering.
Description: Online training with immediate access upon enrollment. Good 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:
Who Should Take This Course?
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
Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)
What is the IRB/IEC
Composition of the IRB/IEC
Major Responsibilities of the IRB/IEC
Maintenance of Records
An Overview of Investigators Responsibilities
Who Can Be an Investigator?
Responsibilities: Medical Care of Trial Subjects
Responsibilities: Ethical Approval
Responsibilities: Compliance with Protocol
Responsibilities: Investigational Medicinal Products (IMP)
Responsibilities: Records and Reports
Responsibilities: Safety Reporting
Responsibilities: General Responsibilities
Informed Consent and its Importance
Informed Consent Process
Informed Consent Form
Revisions to Informed Consent
This training program has been developed to train employees with Intermediate Knowledge of Good Clinical Practices (cGCP).