Data protection is vitally important in clinical trials. The data of trial participants may only be collected with their consent and with strict regard to data protection regulations. The consent is usually given by signing the patient information and consent form. This form contains a specific paragraph on data protection of trial participants. Unless required by law, only investigators and their trial staff have access to confidential data. Confidential or “personal” data are data which include the names of trial participants.
For safety reasons it is also possible that representatives of local and/or foreign health offices, responsible ethics committees as well as commissioners of the clinical trial require access to confidential data. However, these persons are obliged to legal confidentiality.
If data are forwarded nationally and internationally, this is only done for statistical reasons and in a coded and anonymised way. This means that the names of trial participants are never mentioned in the forwarded data or in any publications. The only way that a trial participant can be retraced is by the patient identification number, which every participant receives at the beginning of the trial. Retraces are only done in cases of emergency or for safety reasons.