Sponsor Responsibilities under EU CT Directive

Requirement for a sponsor under EU CT Directive

For every trial that falls within the remit of Directive 2001/20/EC, a person or organisation must take on the responsibility of sponsor.
The Sponsor may make arrangements to delegate any, or all, of their trial-related functions to an individual, company, institution or organisation. However, in all such cases, the sponsor shall retain overall responsibility for ensuring that the conduct of the trials and the final data generated by those trials comply with Directive 2001/20/EC and Directive 2005/28/EC.

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Sponsor’s key responsibilities under EU CT Directive

(Note that this information is indicative only. Please contact us for more detail on Sponsor responsibilities and how we can ensure your study is in compliance with the EU Clinical Trials Directive.)

Competent Authority Authorisation and Ethics Committee Approval

The sponsor of the clinical trial must:

Request clinical trial authorisation (CTA), amend the request where applicable
Allow inspection of premises outside the EU if required
Give notice of amendments to CTA, make representations about amendments
Give notice of amendments to the protocol
Give notice that a trial has ended

Adherence to Good Clinical Practice and Conduct

The sponsor must not conduct a trial or act as a sponsor for a study that does not comply with the conditions and principles of Good Clinical Practice. The sponsor of the clinical trial must:

Take appropriate urgent safety measures (with participating Investigators)
Ensure Investigational Medicinal Products are available to subjects free of charge

Responsibility for Pharmacovigilance

The sponsor of the clinical trial must:

Keep records of all adverse events reported by Investigators
Ensure recording and prompt reporting of suspected unexpected serious adverse reactions (SUSARS)
Ensure all SUSARs, including those outside the EU, are entered into central European database
Ensure Investigators are informed of SUSARs
Provide annual list of suspected serious adverse reactions and a safety report

Responsibility for Insurance and Indemnity

The sponsor of the clinical trial must ensure that provision has been made for insurance or indemnity to cover the liability of the sponsor and investigator which may arise in relation to the clinical.

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Definitions

“Sponsor” means, in relation to a clinical trial, the person who takes on responsibility for the initiation and management (or for arranging the initiation and management) of, and the financing (or arranging the financing) for that clinical trial.

“Investigator-sponsor” means, in relation to a clinical trial, a chief investigator who is also acting as the sponsor for that clinical trial.

“investigational medicinal product” means a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including a medicinal product that is already the subject of a marketing authorisation, but -

is used, formulated or packaged in a way different from the form that is the subject of the authorisation, or
is used for an indication that is not included in the summary of product characteristics under the authorisation for the product, or
is used to gain further information about the form of the product that is the subject of the authorisation

“Non-commercial clinical trials” are clinical trials conducted by researchers without the participation of the pharmaceutical industry. For that reason the following criteria may be followed to define non-commercial clinical trials:

Characteristics of the sponsor:

The sponsor should be a university, a hospital, a public scientific organisation, a non profit institution, a patient organisation or a researcher;
The ownership of the data of these trials should belong to the sponsor listed in the first bullet point;
No agreements between the sponsor and third parties allowing them to use the data for regulatory or marketing purposes should be in place; and
The design, conduct, recording and reporting of the clinical trial should be under the control of the sponsor.

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