Clinical Trial Safety Reporting Requirements in the EU and USA
|Program/Course ID: CT14|
Enrollment Period: 6 months.
Average Learning Time: ~120 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2 CPD Credits.
Method of Training: Online, Asynchronous, Self-paced eLearning.Accessibility: 24/7 access to all program materials.
Catalog: Drug Safety.
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: $225.00 USD
Document your dedication to quality, compliance, safety, and job performance by earning a training certification.Training Program: Clinical Trial Safety Reporting Requirements in the EU and USA
Training Provided By: Biopharma Institute
Schedule: Self-paced. Immediate access to training materials upon enrollment.
This course sets out the legal and regulatory requirements for safety reporting in clinical trials of medicinal products under the jurisdictions of the European Union and the USA. It builds on the foundation laid by our companion course CT13, Safety Reporting in Clinical Trials, and provides greater detail of specific requirements in those jurisdictions.
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.
Legal and regulatory requirements in the EU
In this session, we set out the legal and regulatory requirements for safety reporting under the EU Clinical Trials Regulation. We specify the responsibilities of investigators and those of sponsors. We distinguish those reports that must be submitted by sponsors to the EudraVigilance portal and those that must be submitted to the Clinical Trials Information System. We specify the format and terminology that must now be used, and we identify the tools and pathways for electronic submission. Finally, we outline significant differences in requirements under the Clinical Trials Directive.
Legal and regulatory requirements in the USA
In this session, we set out the legal and regulatory requirements for safety reporting in clinical trials conducted (in the USA or elsewhere) under an Investigational New Drug application (IND) to the US Food and Drug Administration (FDA). We specify the responsibilities of investigators and those of sponsors. We describe the criteria for IND safety reports to the FDA, and the content, format and timing of their submission. We discuss investigators' obligation to report unanticipated problems to institutional review boards. Finally, we discuss IND annual reports and other safety reporting issues.
Multiple-choice mastery assessment.
Audience: Clinical research, drug safety, and regulatory affairs staff, healthcare professionals
Category: Clinical trials, drug safety, regulatory affairs
Region: Europe, USA
Who will benefit from this course?
This course provides essential information for clinical research, drug safety, and regulatory affairs staff of sponsors of clinical trials, as well as investigators and other healthcare professionals who undertake clinical trials.
Clinical Trial Safety Reporting Requirements in the EU and USA is included in the following professional certification programs:
Drug Safety and Pharmacovigilance Professional Certification ProgramCourse ID: AV01
Price: $995.00 (USD) | Learn more
Good Pharmacoepidemiology Practice Professional Certification ProgramCourse ID: AV01B
Price: $1195.00 (USD) | Learn more
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