Remember to Enter Start Dates in CTIS

Both when a new trial is authorized in the CTIS database, or a trial is transferred during the transition to CTIS, the sponsor must remember to enter dates in CTIS for the trial for both “start trial” and “start recruitment.”

This is a technical necessity to ensure that the trial, and thus the approval, does not expire.

The dates must be specified for each participating country.

More information can also be found on the GCP units’ website: 15-day notifications in CTIS for approved trials.