In starting a Clinical Trial, an application submitted by sponsor and approval by competent authority in Member State where trial will take place is required, in which a 60-day system is proposed. In any case that the authority does not accept request, the sponsor is given one opportunity to amend request.
Negative approval system – if have not heard within a specific number of days, can go ahead with CT.
If planning a trial in the UK then go to Department of Health website which contains a lot of useful information.
Some CTS may require specific prior authorization depending upon characteristics of medicinal products involved. Guidance on the format and contents of the request have been drawn up by the Commission.
A number of points from these guidance notes should be noted:
- Attachment 1 – declaration of the Qualified Person that the manufacturing site works in compliance with EU GMP (when applicable) most EU competent authorities require.
- Attachment 2 – Investigational Medicinal Product Dossier – the IMPD should include summaries of data on the quality and manufacture of the IMP substance and product.
- Annex 1 Section F – manufacturer or importer responsible for the release of the IMP, asks whether the site has been inspected by the EU authorities.
CONDUCT OF A CLINICAL TRIAL
This is the system in making amendments to Clinical Trials. This must be agreed with the Competent Authorities and Ethics Committee in advance, but the sponsor is required to take appropriate measures to protect patient health in the event of any immediate hazard.
Sponsor must immediately inform the competent authority and Ethics Committee of these new events and actions taken. Ethics Committee should give an opinion within 35 days regarding the proposed amendment.
Sponsor must notify authorities within 90 days that a trial has ended. If it has to be terminated, this period is reduced to 15 days.
EXCHANGE OF INFORMATION
Information from applications will be available on a database, (EudraCT database), accessible only by other competent authorities, the EMEA and EU Commission.
Detailed guidance on the relevant data to be included in the database and methods for electronic communication of the data has been published. Data to be included:
· Description of the IMP, Appendix 1 D.2
- Authorized site responsible in the community for the release of the investigational medicinal product in the community, Appendix 1 F
- The favorable opinion of the Ethics Committee
- The declaration of the end of the Clinical Trial, and
- A reference to the inspections carried out on conformity with Good Clinical Practice