Enrollment Period: 3 months.
Average Learning Time: ~180 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 3 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 $195.00
Document a dedication to your career and job performance by earning a training certification from Biopharma Institute.Training Program: GCP: ICH Good Clinical Practice (ICH-GCP)
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 a set of internationally recognized ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorization of clinical trials and the acceptance of their data. The International Council for Harmonization's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.
This module introduces GCP and sets it in the context of typical collaborative work in clinical research. We discuss the role and goals of the International Council for Harmonization and the principles of GCP. We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators and monitors. We explain the rationale and execution of the informed consent process, and discuss issues that arise in practice.
The module is fully up to date with Revision 2 of ICH GCP.
This training meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate BioPharma, Inc. as necessary to enable mutual recognition of GCP training among trial sponsors.
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.
Module overview: Sets out the module's scope, objectives and notes on terminology.
ICH, harmonization, and principles of GCP: Describes the ICH's role in the harmonization of regulations, introduces its guideline E6, and sets out the principles of GCP.
Clinical research teamwork: Introduces the major roles in a typical clinical research project and outlines their duties and relationships.
Documentation: Identifies the documents designated by ICH GCP as essential to the conduct of a clinical trial, describes important examples, and outlines how they should be maintained.
Sponsor responsibilities: Duties and functions discussed in this session include risk-based quality management, selection of investigators, trial management, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports.
Investigator responsibilities: Duties and functions discussed in this session include: provision of adequate resources and oversight of delegatees; liaison with institutional review boards / independent ethics committees; compliance with protocol; management of investigational product(s), informed consent and data records; and safety reporting.
Informed consent: Sets out the principles and requirements of informed consent, describes the process, and provides examples of practical issues confronting healthcare professionals and subjects.
Monitor responsibilities: Explores the responsibilities of the monitor and provides insight into key challenges. Describes assessment of investigators and investigational sites, education and trial initiation, risk-based monitoring of clinical conduct, including CRF review and source document verification, and trial close-out. Discusses noncompliance and how to deal with it.
Assessment: Multiple-choice mastery assessment.
Who will benefit from this module?
This course provides essential learning for clinical research associates, project managers and other employees of companies sponsoring clinical research, as well as all healthcare professionals involved in conducting clinical trials. Anyone who needs to develop an understanding of the importance of Good Clinical Practice and its application should take this course.
GCP: ICH Good Clinical Practice (ICH-GCP) is Included in the Following Professional Certification Program(s):
Clinical Trials Monitoring Professional Certification Program for CRAs
Course ID: GCP00A
Price: $695.00 (USD) | Learn more
Clinical Trials Management (US & EU) Professional Certification Program
Course ID: GCP00A1
Price: $1295.00 (USD) | Learn more
Obtaining Approval for Clinical Trials in US & EU for Regulatory Professionals
Course ID: GCP00A2
Price: $895.00 (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.