Enrollment Period: 6 months.
Average Learning Time: ~15 minutes.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Credit Hours: 0.5 credits.
Digital Badge: Issued upon completion.
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
THIS IS A FREE COURSE
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Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: ICH-GCP: Good Clinical Practice, An Abridged Course
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
The pharmaceutical industry is currently undergoing a large number of regulatory changes. Individuals that are involved in research will be directly affected. As we carry out our duties there is always the risk of compromising the data quality that we generate and the risk of breaching the various codes of ethics. An understanding of the principles and background of Good Clinical Practice are critical to ensuring credible data, high quality, and ethical research. This abridged online course provides a demonstration of the GCP: ICH Good Clinical Practice (ICH-GCP).
Course content includes a brief introduction to ICH GCP guidelines, sponsor's responsibilities and a final assessment. The entire program must be viewed by students in order to pass. An online, multiple-choice final assessment score of 80% or better is required to immediately receive the certificate of completion in a PDF format.
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.
This abridged online course provides a demonstration of the full length course, titled 'GCP: ICH Good Clinical Practice (ICH-GCP) - Course ID: GCP001'.
- Learning Expectations
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.
Students completing this course should achieve an understanding for how the Biopharma Institute courses are delivered, the requirements for accomplishing training certifications from the Biopharma Institute, and how to access the certificate of completion once all requirements are satisfied. A digital badge is also delivered upon successful completion.
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.