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Safety Reporting in Clinical Trials (Adverse Event Reporting)

Safety Reporting in Clinical Trials (Adverse Event Reporting) Certification Training

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Program/Course ID:CT13
Enrollment Period:12 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:Four (4) free trial courses are available.
Group/Employee Training:Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
  Price: $225.00 USD  
CPD Accredited Training

Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.

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 12-month period. A certificate of completion is immediately accessible in PDF format after satisfying the requirements.

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 promptly launched and made available to the student upon course completion. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode.

Once all training requirements have been satisfied the achievement can be verified from our website using the unique certificate ID or QR barcode located on the certificate. For professional certification programs, a digital badge is additionally issued to verify training and document the achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Twitter, and Badgr.

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.


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

This Course is Included in the Following Professional Certification Program(s):

Professional Certification Program:

Drug Safety and Pharmacovigilance Professional Certification Program

Program ID: AV01
Price: $995.00 (USD)

Professional Certification Program:

Good Pharmacoepidemiology Practice Professional Certification Program

Program ID: AV01B
Price: $1195.00 (USD)

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device 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-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.

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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:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally 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.

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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For quotes or invoices please provide the course(s) and number of students.