The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.
Applicant for Clinical Trial Applications (CTA)
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
Applicant for a CTA
An applicant is a person who requests the authorization of a clinical trial, notifies substantial amendments and declares the end of a clinical trial to the competent authorities/ethics committees in the European Union. An applicant represents the sponsor and acts as the contact point for the competent authorities/ethics committees. Applicants are optional, the sponsor or EU legal representative can act as the primary contact should they wish to.
Applicant in the European Union
In the European Union, the applicant is formally identified in the cover letter and in sections C.1/C.2 of the EudraCT form. A letter authorizing the applicant to communicate on behalf of the sponsor is usually included in the Clinical Trial Application. The competent authorities/ethics committees will send all communications to the applicant and will only share information related to the clinical trial if the request comes from the applicant. In some countries, local contacts are involved in addition to the applicant, if the applicant is not based in the concerned country.
Latest Glossary Definitions
Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. It should contain company questions, justifications or company positions, and appropriate summary information.
The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group.
In relation to Policy 70, CCI shall mean any information contained in the clinical reports submitted to EMA by the applicant/MAH which is not in the public domain or publicly available and where disclosure may undermine the legitimate economic interest of the applicant/MAH.
Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device.
A CE Technical File is a comprehensive collection of documents providing medical device composition, specifications, manufacturing process, rationale for qualification and classification, non-clinical testing results and clinical evaluations, risk analysis and instructions for use/Labeling.
A systematic evaluation of the evidence on the outcomes of different drugs or other options for treating, preventing, or diagnosing a medical condition.
The conduct and/or synthesis of research comparing different benefits and harms of alternative interventions and strategies to prevent, diagnose, treat, and monitor health conditions in routine clinical practice (i.e. the real-world setting).
Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.
A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.