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

Monitoring Plan

Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives, and the critical data and study procedures.

The plan describes the reference policies and procedures to follow.

Project Management Plan

The purpose of this document is to define the scope of activities, outline responsibilities (define task and roles) and provide guidance on a specific project.

EUDAMED

Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.

ISO14155

International standard addressing good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices for regulatory purposes.

Redaction

In relation to Policy 70, the process of permanently obscuring CCI or PPD in the clinical documentation submitted to EMA by the applicant/MAH before the documents are published. Tthe redaction should appear as a light blue box with a black 'PPD' label or as a black box with a red 'CCI' label.

Protection of personal data (PPD)

In relation to Policy 70, “Personal data” is any information relating to an identified or identifiable natural person; an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.

Lay person summary (of a clinical trial)

The EU Clinical Trials Regulation 536/2014 (Article 37) requires sponsors to provide summary results of clinical trials in a format understandable to laypersons. These lay person summaries will be made available in the EU Portal and Database.

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