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

Informed Consent Form

An ICF is the document with which the subjects (and/or their representative(s)) confirm that they agree to participate in a clinical trial. The term ‘informed’ reflects the fact that the subject has been fully informed about the clinical trial in a prior interview and with the help of the Patient Information Leaflet. The ICF is dated and signed by both the subject/representative(s) and the member of the investigating team who conducted the interview. Assent means that they agree to take part.

ICF in the European Union

According to the Directive 2001/20/EC, the procedure for obtaining informed consent is one of the aspects to be considered by the Ethics Committees (ECs) in their assessment of a clinical trial. The ICF is therefore included in all EC applications. It should be written in the appropriate language(s) of the country concerned by the clinical trial. It is classically attached to the Patient Information Leaflet.

Latest Glossary Definitions

Value Proposition

The value proposition is composed of a common understanding of patient flow to identify where value is being lost, where new value can be created and how the company can best capture that value.

Health Economics and Outcomes Research (HEOR)

Health Economics and Outcomes Research (HEOR) is the most common label given to the function within pharmaceutical and life science companies with the responsibility for generating evidence of value of new interventions for reimbursement agencies

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.


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.


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.


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