Enrollment Period: 12 months (1 year).
Average Learning Time: ~12 - 18 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Courses: Program includes 8 individual courses (see courses).
Outline/Syllabus: See individual course pages for outline.
Digital Badge: Issued upon completion.
Post-nominal Letters: CTPro™.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Five (5) free trial courses are available.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
Price: $1295.00 USD
Document your dedication to compliance, safety, and job performance by earning a professional certification.Training Provided By: Biopharma Institute
Outline/Syllabus: See individual course pages for outline.
The Clinical Trials Management (US & EU) Professional Certification Program is for regulatory affairs personnel, clinical managers, project managers, investigators, and clinical research associates. It is also available to those interested in moving their career into these positions, such as clinical trial coordinators with the desire to grow their career in clinical research and regulatory management positions.
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 program 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.
The purpose of investigational site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified, trained and committed staff with adequate time and facilities, and that it is fully prepared for the safe and successful conduct of the clinical trial. In this program we set out the criteria, procedures and documentation for evaluating a site and setting up a trial there.
This program teaches the students about how clinical trials fit into the process of drug development. Key historical events which have led to the development of controlled clinical trials are outlined. The purpose of clinical trials are specified and further explored through the regulations that apply to them, specifically, the identification of appropriate codes, and outlining their features. The program goes on to discuss the environment of cost control in which the pharmaceutical industry of today operates. Upon completing this program, students will have a strong understanding of how to accomplish the following: Provide an outline of the environmental cost control in which the pharmaceutical industry of today operates; give a description of how clinical trials fit into the process of drug development; outline the ethical and legislative framework; describe the purpose behind clinical trials; provide a summary of the key historical events which led to the development of controlled clinical trials.
This program describes what investigational medicinal product sponsors, contract research organizations and clinical investigators can expect when they undergo inspection or audit. It focuses in particular on inspection by European and US regulators. It moves on to describe general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. It describes post-inspection actions by the regulator and the inspected party.
The application process to conduct FDA-regulated clinical trials in USA and how to obtain approval to conduct clinical trials in the EU are described in detail.
Assure Employee Compliance and Understanding for the GCP and the Regulatory Standards and Guidelines for Conducting Clinical Trials in US and EU:
Clinical Trials Management (US & EU) Professional Certification Program includes these 8 individual courses:
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately 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 following enrollment into any program or course. Students may attempt the final assessments any number of times, as needed, to achieve a passing score.
Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format.
Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display the accomplishment.
Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline.
Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world.
Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate.
Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical industries.
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 and large-scale training requests.
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.