Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by the trial sponsor.

Investigational Medicinal Product Dossier

The Investigational Medicinal Product Dossier is a document divided in four distinct sections. It provides information on (i) the quality, manufacture and control of the IMP, (ii) the non-clinical studies conducted with the IMP, (iii) the clinical use of the IMP, and (iv) the overall risk / benefit assessment of the IMP in the proposed trial.

IMPD in the European Union

An IMPD is one of the essential documents that form the CTA submitted to the EU Competent Authorities (CAs) for non-authorized IMPs. Where the IMP is subject of a marketing authorization, the Summary of Product Characteristics, complemented by additional data as necessary, could be submitted in lieu of the IMPD.

Latest Glossary Definitions

Efficacy-Effectiveness Gap

The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials.

Briefing Book (or briefing materials)

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.

Clinical Impact

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.

Commercially Confidential Information (CCI)

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.

Clinical Evaluation Report (CER)

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.

CE-Marking Technical File

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.

Comparative Effectiveness Research (CER)

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 Dossier

Core value dossiers are used in the frame of reimbursement negotiations and to support HTA submissions, as well as national and local payers.

Core Reimbursement Dossier

A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement.