Emergency envelopes

Management of emergency envelopes

In the context of double blind clinical trials, the effect of pharmaceuticals is tested under medical supervision, on two defined groups of patients: the patients of one group are administered placebos, and the second group takes the pharmaceutical in question. Neither the patients nor the attending physicians know to which group a patient belongs (hence the term “double blind”).

To ensure a maximum of safety, all data relating to the procedure and organisation of the trial must be communicated to a third, independent party. This is particularly relevant if placebos or pharmaceuticals are not used as intended or misused (e.g., pharmaceuticals taken by children playing, or used for suicide attempts).

The Poison Control Centre (VIZ) offers emergency services around the clock so that experts are available in the event of incidents during double blind clinical trials and studies. In the case of blinded clinical trials, emergency documents (the trial protocol, the investigator’s brochure and a sealed list of codes) are kept at VIZ Vienna for safety reasons.

This information on the trial is treated confidentially, kept sealed and may be disclosed only to the doctors on duty in defined cases of emergency (e.g., serious adverse events).

This service of ÖBIG Beratung enhances safety in the context of clinical trials and is provided to clinical research institutes.

Contact: Klaus Kellner