Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials Regulation
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Download Document your dedication to quality, compliance, safety, and job performance by earning a certification of training.Training Program: Clinical Trials: How to Gain Authorization for Clinical Research Under the EU Clinical Trials RegulationTraining Provided By: Biopharma Institute Website: https://www.biopharmainstitute.com Schedule: Self-paced. Immediate access to training materials upon enrollment. Description:  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'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. |
Outline: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. Assessment Multiple-choice mastery assessment. | Objectives: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
Audience: Regulatory affairs professionals, clinical development staff, healthcare professionals Category: Clinical trials, regulatory affairs Region: Europe Level: Introductory/intermediate | |
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| 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. |
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