The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorised.

The trial protocol (including statistical design), the technical application and documentation shall be submitted by the sponsor and/or investigator for an opinion to the relevant ethics committee.

The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorized.

For the subsystem, being subject of the EC verification procedure, the adjudicating entity must contract only with manufacturers, whose activities contributing to the subsystem project to be verified (design, manufacturing, assembling, installation) are subject to an approved quality system for design, manufacture and final product inspection and testing as specified in point 3, and which shall be subject to surveillance as specified in point 4.

The final report shall be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorised.

The documents can be retained for a longer period, however, if required by the applicable regulatory requirements or by agreement with the sponsor.

It is the responsibility of the sponsor to inform the hospital, institution or practice as to when these documents no longer need to be retained.

For the subsystem, being subject of the EC verification procedure, the adjudicating entity must contract only with manufacturers, whose activities contributing to the subsystem project to be verified (design, manufacturing, assembling, installation) are subject to an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 and which shall be subject to surveillance as specified in point 4.

The final report shall be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorized.

after the commencement of the clinical trial, the sponsor may make amendments to the protocol.

If the sponsor fails to amend the request accordingly, the request shall be considered rejected and the clinical trial may not commence.

If the trial has to be terminated early, this period shall be reduced to 15 days and the reasons clearly explained.

Unless Member States have established precise conditions for exceptional circumstances, investigational medicinal products and, as the case may be, the devices used for their administration shall be made available free of charge by the sponsor.

the amounts and, where appropriate, the arrangements for rewarding or compensating investigators and trial subjects and the relevant aspects of any agreement between the sponsor and the site;

within 90 days of the end of a clinical trial the sponsor shall notify the competent authorities of the Member State or Member States concerned and the Ethics Committee that the clinical trial has ended.

The sponsor may not start a clinical trial until the Ethics Committee has issued a favourable opinion and inasmuch as the competent authority of the Member State concerned has not informed the sponsor of any grounds for non-acceptance.

Before commencing any clinical trial, the sponsor shall be required to submit a valid request for authorisation to the competent authority of the Member State in which the sponsor plans to conduct the clinical trial.

If the opinion of the Ethics Committee is favourable and the competent authorities of the Member States have raised no grounds for non-acceptance of the abovementioned substantial amendments, the sponsor shall proceed to conduct the clinical trial following the amended protocol.

The sponsor shall keep detailed records of all adverse events which are reported to him by the investigator or investigators. These records shall be submitted to the Member States in whose territory the clinical trial is being conducted, if they so request. Article 17 Notification of serious adverse reactions 1.

Once a year throughout the clinical trial, the sponsor shall provide the Member States in whose territory the clinical trial is being conducted and the Ethics Committee with a listing of all suspected serious adverse reactions which have occurred over this period and a report of the subjects' safety.

Where a competent authority has objective grounds for considering that the sponsor or the investigator or any other person involved in the conduct of the trial no longer meets the obligations laid down, it shall forthwith inform him thereof, indicating the course of action which he must take to remedy this state of affairs.

Where a Member State has objective grounds for considering that the conditions in the request for authorisation referred to in Article 9(2) are no longer met or has information raising doubts about the safety or scientific validity of the clinical trial, it may suspend or prohibit the clinical trial and shall notify the sponsor thereof.

Subject to any arrangements which may have been concluded between the Community and third countries, the Commission, upon receipt of a reasoned request from a Member State or on its own initiative, or a Member State may propose that the trial site and/or the sponsor's premises and/or the manufacturer established in a third country undergo an inspection.

without prejudice to point (a), in the light of the circumstances, notably the occurrence of any new event relating to the conduct of the trial or the development of the investigational medicinal product where that new event is likely to affect the safety of the subjects, the sponsor and the investigator shall take appropriate urgent safety measures to protect the subjects against any immediate hazard.

For the subsystem, which is the subject of the EC verification procedure, the adjudicating entity must contract only with manufacturers, whose activities contributing to the subsystem project to be verified (manufacturing, assembling, installation) are subject to an approved quality system for manufacture and final product inspection and testing as specified in point 3 and subject to surveillance as specified in point 4.

To verify compliance with the provisions on good clinical and manufacturing practice, Member States shall appoint inspectors to inspect the sites concerned by any clinical trial conducted, particularly the trial site or sites, the manufacturing site of the investigational medicinal product, any laboratory used for analyses in the clinical trial and/or the sponsor's premises.

If those amendments are substantial and are likely to have an impact on the safety of the trial subjects or to change the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant, the sponsor shall notify the competent authorities of the Member State or Member States concerned of the reasons for, and content of, these amendments and shall inform the ethics committee or committees concerned in accordance with Articles 6 and 9.

For the subsystem, subject of the EC verification procedure, the adjudicating entity must contract only with manufacturers, whose activities contributing to the subsystem project to be verified (design, manufacturing, assembling, installation) are subject to an approved quality system for design, manufacture and final product inspection and testing as specified in point 3 and which shall be subject to surveillance as specified in point 4.

the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect;