GCP: Clinical Trial Documentation (Fundamentals)
 | Enrollment Period: 12 months. Average Learning Time: ~15 minutes. Method of Training: Online, asynchronous, self-paced eLearning. Accessibility: 24/7 access to all program materials.Credit Hours: 0.5 credits. Digital Badge: Issued upon completion. Catalog: Clinical Trials Management and Monitoring. 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). Price: $99.00 USD |
Download Program DetailsDocument your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: GCP: Clinical Trial Documentation (Fundamentals)Training Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  Regulatory authorities tend to abide by the maxim that 'If it isn't documented, it didn't happen'. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of Good Clinical Practice (GCP) and compliance with regulatory requirements, as well as enabling effective management of the trial.
In this module we describe important examples of the documents designated by ICH GCP as essential to the conduct of a clinical trial. Certification Requirements: Students must view the entire course and successfully pass an online, multiple-choice final assessment within a 12-month period. 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. |
Outline:Module overview: Sets out the module's scope, objectives and notes on terminology. - 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. - Final Assessment. - Certificate of Completion. | Objectives:Who will benefit from this course? This module is intended for all those involved in the preparation, design, conduct or analysis of clinical trials. It will be useful to new entrants to the field or as a refresher for staff, including clinical research associates and data managers, in the clinical/medical departments of pharmaceutical or biotechnology companies or in contract research organizations. It will also be of interest to clinical investigators, study coordinators, and other healthcare staff working on clinical trials. | |
Benefits of Training with Biopharma Institute
| Immediate access to courses: | Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment. |
| Self-paced, asynchronous eLearning: | 24/7 access to all course materials and assessments for 12 months. |
| Open enrollment: | No prior course prerequisites or work experience required. |
| Expertise: | Courses developed by subject matter experts (SMEs) in the area being taught. |
| Current and validated: | Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited. |
| Optimized for learning: | Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter. |
| Secure and safe access: | Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance. |
| Flexible final assessments: | Multiple-choice questions can be taken repeatedly until a passing score is achieved. |
| Direct access to certificates: | Certificate of completion is instantly available once requirements have been fulfilled. |
| Verification of training: | Certificates verifiable online with digital badges issued for all professional certification programs. |
| Training manager access: | A proprietary portal offers access to download enrollment reports, training records, account balance, and more. |
| SCORM-compliant courses: | Courses can be delivered directly to most corporate Learning Management Systems (LMS). |
| Purchase orders (POs): | POs are accepted from all companies. Request an invoice when starting the procurement process. |
| Reimbursement: | Some employers may reimburse their employees for training expenses. Check your company's policy. |
| Financial assistance: | Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option. |
| Career advancement: | Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties. |
