In certain types of trial designs, the investigator and patient do not know whether the patient receives a placebo drug (inactive substance) or a medicine containing an active substance. But in some situations, the investigator needs to know what the patient has been given, in which case it should be possible for the investigator to break the blinding.
The new question from EMA deals with whether or not the investigator is to contact the sponsor before he or she breaks the blinding for a patient in a trial.
The question was discussed in the Clinical Trial Facilitation Group and the GCP inspectors' working group under EMA. It was agreed that the investigator can break the blinding without contacting the sponsor.
Follow this link to see the new question: EMA: Q&A: Good clinical practice (GCP)