Legal representation set out in the EU Clinical Trial Regulation (2024)

FAQs

What is a legal representative for clinical trials in the EU? ›

Legal Representatives and EU LRs play crucial roles in protecting the rights, safety, and well-being of trial subjects. They ensure that all aspects of a trial comply with ethical guidelines and legal regulations, from participant recruitment to data collection and reporting.

The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. The evaluation, authorisation and supervision of clinical trials are the responsibilities of EU Member States and European Economic Area (EEA) countries.

“LAR means an individual, or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.” 45CFR.

Commission legal obligations in the context of Regulation (EU) No 536/2014. The inspection of clinical trials may concern good clinical practice as regards the conduct of clinical trials as well as good manufacturing practices as regards the manufacturing of the investigational medicinal products.

A legal representative is a natural or legal person established in the EU that is explicitly designated to act on behalf of a data intermediation services provider or a data altruism organization, which may be addressed by the respective competent authorities in addition to or instead of the data intermediation ...

An authorised representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under the ...

The EUCTR replaces the previous European Clinical Trials Directive and governs the conduct of clinical trials in all EU Member States, including Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, ...

One of the main differences between the EU medical device regulation and the FDA is that a clinical evaluation must be performed for all medical devices, no matter the class. As risk increases, so do requirements. Higher risk devices do require clinical investigations (tests on humans) in both markets.

Guidelines are non-binding documents which aim to facilitate the implementation of European directives.

A Legally authorized representative (LAR) is an individual or judicial or other body authorized under applicable law to make decisions on behalf of another individual. LARs may, for example, provide consent on behalf of a prospective subject to the subject's participation in research.

Why does representation matter in clinical trials? ›

By restricting the demographics of certain populations included in clinical studies, we then sometimes restrict the use of therapeutics for certain people. Lack of representation may thus impede access to a specific therapeutic agent for those who need it most.

A person with legal authority to make health care decisions on behalf of the individual. Examples: Health care power of attorney. Court appointed legal guardian. General power of attorney or durable power of attorney that includes the power to make health care decisions.

Under the EU legal order, the Basic Regulation has general application. It is binding in its entirety and directly applicable in all Member States. The main objective of the Basic Regulation is to “establish and maintain a high uniform level of civil aviation safety in the Union” — Article 1(1).

This Regulation lays down requirements for the carrying out of the statutory audit of annual and consolidated financial statements of public-interest entities, rules on the organisation and selection of statutory auditors and audit firms by public-interest entities to promote their independence and the avoidance of ...

The Commission is the sole EU institution tabling laws for adoption by the Parliament and the Council that: protect the interests of the EU and its citizens on issues that can't be dealt with effectively at national level. get technical details right by consulting experts and the public.

Designated legal representative means an attorney, physician, funeral service director, genealogist, or other agent of the subject, or an immediate family member of the subject, who has been delegated the authority to access vital records.

CTIS for authorities

Regulatory authorities, such as national competent authorities and ethics committees of EU Member States and European Economic Area countries can participate in the assessment, authorisation or oversight of a trial.

The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.

Principal investigator (PI)

Also called a primary investigator, this person oversees all aspects of a clinical research study. They develop the study concept; write a detailed description of how the study will be conducted; and submit it for approval to the site's institutional review board (IRB).