Substantial amendments are defined according the Law 21/2014 of 16 April and the directive 2001/20/CE and also the Communication from the Commission of 30.03.2010 (2010/C 82/01).
Substantial amendments submitted during the review process are evaluated with all the other documentation, and the time frame is according with the new legislation 20 days. If additional questions (for the main trial) have already been raised, there is a new round of questions according with the amendment.
When an unfavourable opinion is given to the clinical trial protocol the amendment consequently obtains the same decision.
Investigators and Sites
For the time being the suitability of investigators is decided by the analysis of CVs. Investigational sites are considered suitable if the clinical director of the medical centre declares so, explicitly reporting the human and material resources disposable in their site to do each specific clinical trial protocol.
The national law requires that all financial arrangements (financial contracts between sponsors and health institutions) that are conducted with the board of each participating healthcare institution must be presented and approved by CEIC. The new law establishes that the site for the study has to approve the financial arrangements in 15 days from the request of the sponsor or researcher.
The compensation arrangements for study subjects
The compensation arrangements for study subjects are required to be fully detailed in the clinical trials application and are evaluated in the review process. The reimbursement of the participants for all expenses with transportation, meals, and others such as salary lost is mandatory by law.