Start of the clinical trial
Article 2 (25) of the CTR defines the start of the clinical trial as the first act of recruitment of a potential subject for a specific clinical trial, unless defined differently in the protocol.
In some cases, the sponsor may define the start of the trial differently than first act of recruitment. It could be, for example, the date of initiation of the clinical trial in the first site or the date when the first study-specific advertisement is published. However, the clinical trial may not start at an earlier date than the authorisation date nor later than the date of the first visit of the first subject.
The date of the first visit of the first subject should be the date the first subject or his/her legally designated representative signs his/her first informed consent to participate in the clinical trial.
- The start date of the clinical trial in a MSc should be reported in CTIS within 15 days from the start of the clinical trial in relation to that MSc (art 37 CTR).
- The date of the first visit of the first subject in a MSc should be reported in CTIS within 15 days from the first visit of the first subject in relation to that MSc (art 36 CTR).
See also Question 10.1-10.3 of the Q&A CTR.