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

Clinical Trials:  How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation Certification Training
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Program/Course ID: CT11
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.
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 Authorization 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 favorable 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 harmonized procedure for gaining and maintaining authorization 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 authorization. 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 authorization to conduct clinical trials under the Regulation, and it summarizes 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 authorized 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 12-month period. 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 authorization 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 authorization 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 authorization 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 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:Certificate of completion is instantly available once requirements have been fulfilled.
Verification of training:Certificates verifiable online with digital badges 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.

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