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Wednesday, February 01, 2023
Home » Clinical Trials: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation

Clinical Trials: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation

Certification Training
Rated 4.5 / 5
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Program/Course ID: CT11
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.
CPD Accredited TrainingCatalog: 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: $225.00 USD  

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

Training Program: Clinical Trials: How to Gain Authorisation for Clinical Research Under the EU Clinical Trials Regulation
Training Provided By: Biopharma Institute

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

Biopharma Institute Reviews

To conduct a clinical trial in one or more member states (MSs) of the European Economic Area (EEA) a sponsor must first gain the approval of each relevant national regulator and the favourable opinion of research ethics committees relevant to the investigational sites. The European Union (EU) Clinical Trials Regulation ensures that the rules for assessing clinical trial applications and for conducting clinical trials are identical throughout the EEA. It establishes a harmonised procedure for gaining and maintaining authorisation for trials in up to 30 countries on the basis of a single electronic application per trial, and subsequent interactions, via a single EU online information system. MSs concerned in a trial collaborate on, and coordinate, its evaluation and supervision, and each MS returns a single decision on authorisation. The Regulation also mandates greater transparency of information on trials. The Regulation applies from 31 January 2022 and, after a grace period of one year, sponsors of all new clinical trials in the EEA must comply with it.

This course sets out the procedures that sponsors need to follow to gain authorisation to conduct clinical trials under the Regulation, and it summarises and links to the extensive guidance available from the European Commission and the European Medicines Agency. Its companion course CT12 sets out the procedures that sponsors need to follow to conduct authorised clinical trials in compliance with the Regulation. The two courses therefore provide an ideal foundation for understanding and complying with the new law.

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.


The Clinical Trials Regulation and its context
This session describes how medicines are regulated in the EEA, identifies key characteristics of the Clinical Trials Regulation (CTR), and specifies its applicability to clinical investigations. It identifies EU online portals and databases relevant to clinical trials and describes the Clinical Trials Information System (CTIS), which is essential to the authorisation and supervision of trials under the CTR. It discusses the concept of low-intervention clinical trial. Finally, it explains how requirements vary during the period of transition from the Clinical Trials Directive to the CTR.

Making a clinical trial application
This session explains how to register to use the CTIS, the distinction between Parts I and II of an application, how a reporting member state (RMS) is appointed, and how to make a full or partial submission of a clinical trial application (CTA). It identifies the contents of a CTA dossier and explains how to apply for deferral of publication of certain contents. It describes relationships among the clinical protocol, investigator?s brochure, and investigational medicinal product dossier, and explains where the reference safety information should appear. It also specifies requirements that must be met by clinical and nonclinical data in applications.

Assessment of application
This session explains how each part of a CTA is validated and assessed by the RMS and other member states concerned (MSCs) in the application. It specifies the sequence of procedures and the deadlines that have to be met by the MSCs and, in the case of requests for information, by the sponsor. It sets out the various decisions on authorisation that may be the outcome of assessment.

Multiple-choice mastery assessment.


Who will benefit from this module?
Regulatory affairs professionals, clinical development staff, and healthcare professionals who sponsor or participate in clinical trials will benefit from this module.

Learning objectives
  • Outline the legal and regulatory framework for clinical trials in the European Economic Area Describe the characteristics and applicability of the Clinical Trials Regulation
  • Identify online portals and databases essential to authorisation and oversight of clinical trials under the Regulation
  • Specify the timeline for transition to the Regulation from the Clinical Trials Directive
  • Identify the contents of a clinical trial application (CTA) dossier as required by the Regulation
  • Describe how to compile and submit a CTA dossier via the Clinical Trials Information System
  • Describe how a CTA is validated and assessed, and how decisions are reached, by the reporting member state and other member states concerned

Audience: Regulatory affairs professionals, clinical development staff, healthcare professionals
Category: Clinical trials, regulatory affairs
Region: Europe
Level: Introductory/intermediate

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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