|Program/Course ID: ELM-901|
Enrollment Period: 3 months.
Allocated Learning Time: ~45 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 0.1 CPD Credits.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: See free trial enrollment courses.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
PRICE: USD $199.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: GCP: An Introduction to Good Clinical Practices - Part 1
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 within a 90-day/3-month period (180 day/6-month period for Professional Certification Programs). Certificate of completion is accessible in PDF format immediately after satisfying requirements.
Biopharma Institute's online training programs include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into the program. Course takers can attempt the final assessment any number of times, as needed, to achieve a passing score. Once all training requirements have been satisfied a certification of training has been achieved and can be verified immediately from our website using a unique certification ID code. The certificate of completion is also instantaneously launched and made available to the student in a PDF format upon completion. Professional certification programs additionally include a digital badge to verify training, and can be displayed on social networking sites, such as LinkedIn.
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).
GCP: An Introduction to Good Clinical Practices - Part 1 is Included in the Following Professional Certification Program(s):
| Training Program For Professionals: |
Good Clinical Practice for Professionals
Course ID: GCPFP
Price: $495.00 (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 which have been developed to promote the retaining of key knowledge, access to references, case studies, and other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and corporations with their training requirements. Biopharma Institute certifications are recognized by a wide spectrum of industries and companies, and our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 200 courses training on clinical research, drug manufacturing, regulatory affairs, validation systems, pharmacovigilance, good clinical laboratory practice (GCLP), data integrity, and medical devices.
Employee / Corporate Training: 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 (1-100 students) and large-scale (100+ students) training requests.
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.