Clinical Trial Transparency and Disclosure Regulatory Systems
EMA CTIS stands for European Medicines Agency Clinical Trials Information System. It is a web-based portal designed to provide a single entry point for the submission and management of clinical trial information by sponsors, investigators, and regulatory authorities across the European Union.
The EMA CTIS is a new system that will replace the current clinical trial submission systems used by individual EU member states. It aims to simplify and streamline the process of submitting and managing clinical trial information, thereby improving the efficiency of the clinical trial approval process and enhancing patient safety. CTIS also aims to improve transparency of clinical trials to interested parties and the general public.
EMA’s CTIS is operational and all new Clinical Trial applications in the European Union must now be submitted via CTIS. Beginning in January 2023 all ongoing trials approved under the current Clinical Trials Directive (CTD) will be governed by the new Clinical Trials Regulation (CTR) and have to be transitioned to CTIS.
The EMA Clinical Trial Regulation (CTR) is a regulation of the European Union (EU) that aims to harmonize and simplify the rules for conducting clinical trials within the EU. The CTR was adopted in 2014 and is in full effect for all initial trial applications in the EU. The CTR replaces the previous Clinical Trials Directive and introduces a number of changes to the regulation of clinical trials in the EU.
One of the key changes introduced by the CTR is the establishment of a centralized, web-based Clinical Trials Information System (CTIS). The CTIS is being developed by the European Medicines Agency (EMA) and is designed to streamline the submission and management of clinical trial information across the EU. The CTIS is expected to simplify the process of submitting and managing clinical trial applications and to improve the efficiency of the clinical trial approval process.
The CTIS will be used by sponsors, investigators, and regulatory authorities across the EU to submit and manage clinical trial applications and to exchange information related to clinical trials. The CTIS will also serve as a central repository for clinical trial information and will provide transparency and public access to clinical trial information.
Overall, the EMA Clinical Trial Regulation and the CTIS are part of the EU's efforts to harmonize and simplify the regulation of clinical trials within the EU, with the goal of improving patient safety and increasing the efficiency of the clinical trial approval process.
To use the EMA’s CTIS system, you will need to register and create an account on the CTIS portal. Depending on your role, you may have different levels of access to the system, such as sponsor, investigator, or regulatory authority.
Once you have access, you can submit and manage your clinical trial information through the EMA’s CTIS system. This includes submitting your clinical trial application, protocol, and other supporting documents, as well as tracking the progress of your application and managing any changes or updates to your trial.
The EMA’s CTIS system is designed to be user-friendly and provide step-by-step guidance throughout the application process. Additionally, the EMA provides resources such as user guides, training materials, and support services to assist users in using the system.
In EMA’s CTIS, public and private documents refer to two types of clinical trial documents that have different levels of access and visibility.
Public documents are available to the general public and can be accessed through the EMA website. These documents include clinical trial summaries, which provide information on the design, objectives, and results of clinical trials conducted in the EU. Public documents also include the European Public Assessment Reports (EPARs), which provide information on the safety and efficacy of medicines approved by the EMA.
On the other hand, private documents are confidential and are only accessible to authorized individuals, such as sponsors, investigators, and regulatory authorities. These documents include clinical trial applications, protocols, and other supporting documents, as well as data and results from clinical trials.
It is important to note that the distinction between public and private documents is based on the level of access and visibility and does not necessarily reflect the quality or importance of the documents. Both public and private documents play a critical role in ensuring the safety and efficacy of medicines in the EU.
The European Medicines Agency (EMA) provides guidance on the use of the Clinical Trials Information System (CTIS) through various documents and resources. Here are some examples:
These guidance resources are regularly updated to ensure that users have access to the most up-to-date information and support. It is important to review these resources carefully before using the CTIS system to ensure that you understand how to use the system effectively and comply with all regulatory requirements.
The European Medicines Agency (EMA) provides training on the use of the Clinical Trials Information System (CTIS) for sponsors, investigators, and regulatory authorities. The training is designed to help users understand how to use the CTIS system to submit and manage clinical trial information, as well as to navigate the various features and functions of the system.
The CTIS training is available in various formats, including webinars, e-learning courses, and classroom-based training. The training is tailored to different user groups, with separate courses available for sponsors, investigators, and regulatory authorities.
The EMA also provides a range of training materials and resources, including user manuals, user guides, and frequently asked questions (FAQs) to help users understand how to use the CTIS system.
Overall, the EMA’s CTIS training is an important component of the roll-out of the new system, as it helps to ensure that users are equipped with the knowledge and skills needed to effectively use the system to submit and manage clinical trial information.
The EMA provides a range of training and related materials for the Clinical Trials Information System (CTIS). Here are some resources you can use to access CTIS training and related materials:
Please visit the Real Life Sciences EMA CTR & CTIS Resource Center for access to the above mentioned materials.
Overall, the EMA provides a range of resources and support to help users access and use the CTIS system effectively. These resources are freely available on the EMA website and are regularly updated to reflect changes and updates to the system
Yes, anonymization of data is required for EMA’s CTIS. The EMA Clinical Trial Information System (CTIS) is a centralized system for the submission, assessment, and monitoring of clinical trials in the European Union. As part of the CTIS, sponsors must submit clinical trial data to the EMA, including information on the trial design, endpoints, results, and adverse events.
To protect the privacy and confidentiality of trial participants, EMA requires that all clinical data submitted to the CTIS must be anonymized. Anonymization involves removing or redacting any information that could be used to identify individual patients, such as names, addresses, dates of birth, and other personal information.
EMA has developed specific guidelines for the anonymization of clinical data, which include a risk-based approach to determining the level of anonymization required based on the sensitivity of the data and the risk of re-identification. The guidelines also provide detailed instructions for how to carry out the anonymization process, including the use of software tools and manual review to ensure that all identifying information has been removed.
Overall, data anonymization is a critical component of EMA CTIS and is essential for ensuring that clinical trial data can be shared in a responsible and ethical way that protects patient privacy and confidentiality.
Documents that are required to be uploaded into the EMA’s CTIS for a clinical trial application may vary depending on the specific trial and the regulatory requirements in the EU member states where the trial will take place. However, generally, the following types of documents are required to be uploaded into the EMA’s CTIS:
Overall, the EMA’s CTIS serves as a centralized system for the submission and management of clinical trial data, and the documents required for submission will depend on the regulatory requirements in the EU member states where the trial will take place. It's important to consult the relevant regulatory authorities and guidance documents for specific requirements.
For more information on data anonymization for EMA’s CTR & CTIS please visit Real Life Sciences Protect Page.
Yes, plain language summaries (PLS) are required to be uploaded into the EMA’s CTIS for clinical trial applications. A plain language summary is a brief summary of the trial protocol and results that is written in plain language so that it can be easily understood by the general public. The PLS is intended to provide a summary of the trial in a way that is accessible to patients and the wider public, and to help promote transparency and public awareness of clinical trials.
Under the EU Clinical Trials Regulation, which governs clinical trials conducted in the EU, sponsors are required to provide a summary of the trial results to the public within 12 months of the end of the trial. The summary should be written in plain language and should be made available on the EU Clinical Trials Register, as well as on the sponsor's website or a publicly accessible repository.
The EMA’s CTIS supports the submission of plain language summaries, and sponsors are required to upload the PLS as part of their clinical trial application into CTIS. The PLS should provide a brief overview of the trial, including the purpose of the trial, the population studied, the intervention being tested, and the trial results. It should be written in language that is accessible to the general public, and should be no more than 2-3 pages in length.
Overall, the inclusion of a plain language summary is an important component of clinical trial transparency and helps to promote public awareness and understanding of clinical trials.
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