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Safety Reporting in Clinical Trials (Adverse Event Reporting)

Certification TrainingProgram/Course ID: CT13
Enrollment Period: 6 months.
Average Learning Time: ~120 minutes.
Additional Resources: Supplemental materials/activities.
Accredited Program: 2 CPD Credits.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
CPD Accredited TrainingCatalog: 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: Safety Reporting in Clinical Trials (Adverse Event Reporting)
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon enrollment.

Biopharma Institute ReviewsThis course explains the regulatory requirements for the reporting of adverse events and suspected adverse reactions in clinical trials. It describes how investigators should report to sponsors, and how sponsors should report to regulatory authorities and other stakeholders in the safety of investigational products. It explains how events are characterized as serious or non-serious, expected or unexpected, and it distinguishes the requirements for each category. It describes controlled vocabularies used for coding of events in reports.

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.


Adverse events and safety reporting
In this session we explain the rationale for safety reporting in clinical trials, and we describe fundamental regulatory requirements. We discuss criteria for reporting, including causality, expectedness and seriousness. We set out the responsibilities of sponsors and investigators for individual-case expedited and aggregate reporting.

Safety reporting by drug sponsors
In this session we describe drug safety operations that will typically be carried out by a sponsor company or contract research organization engaged in clinical trials of medicinal products, and we outline some typical safety-reporting scenarios.

Controlled vocabularies
In this session we explain the requirement for the use of controlled vocabularies of medical terms in safety reporting. We describe the Medical Dictionary for Regulatory Activities (MedDRA) and identify the ISO standards for the identification of medicinal products (IDMP).

Multiple-choice mastery assessment.


Level: Introductory/intermediate
Audience: Clinical research, drug safety and regulatory affairs staff, healthcare professionals
Category: Clinical trials, drug safety, regulatory affairs
Region: Europe, USA, other

Who will benefit from this course?
This course provides essential information for clinical research, investigational product safety, and regulatory affairs staff of sponsors of clinical trials, as well as investigators and other healthcare professionals who undertake clinical trials.

Learning objectives
  • Identify sources of legal requirements, regulatory guidance, and other requirements for the conduct of clinical trials
  • Define reportable events and reactions in drug trials
  • Discuss criteria for causality, expectedness, and seriousness of events
  • Summarize investigators' responsibilities for reporting to sponsors and research ethics committees
  • Specify requirements for expedited reporting by sponsors
  • Outline the role of data monitoring committees
  • Describe typical procedures for handling safety reports
  • Outline follow-up procedures and the content of case narratives
  • Describe trial monitoring activities related to safety reporting
  • Discuss the handling of reports concerning marketed products
  • Discuss the handling of reports of pregnancy and other special cases
  • Outline the management of blinding
  • Outline a typical timeframe for actions taken by a sponsor in response to reports of serious adverse events
  • Identify requirements for periodic aggregate reporting
  • Describe characteristics of the Medical Dictionary for Regulatory Activities
  • Specify the levels of the MedDRA hierarchy
  • Outline the use of MedDRA
  • Outline the ISO standards for the identification of medicinal products

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.

Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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