Medical examinations of trial participants are conducted by specially trained and experienced staff, investigators or study nurses. It is insured that the staff involved in the clinical studies are qualified through a standardized inclusion and regular training.
In the plan for tests the client describes the exact course of the clinical examination. This must be approved by the responsible authorities. The course of individual study related activities, which are not stipulated in the protocol, are regulated in the corresponding standardized instructions, the “Standard Operating Procedures” (SOPs).
A clinical study client sends monitors to our Hamburg clinic at regular intervals to check the quality of the ascertained data from our documents. In this process the personal data of the trial participants is not transferred to the client.
Approximately at 2-yearly intervals we check our work quality internally. This involves especially the compliance of internal and external stipulations for the indisputable/exemplary implementation of studies. This procedure is voluntary and counts as good preparation for external quality measurements (see audits and inspections), which we are obliged to carry out. We record internal audits and implement improvements.
Audits and Inspections
Clients of clinical studies occasionally have audits carried out through independent specialists. The complete activities in the frame of the study and their preparation and post evaluation can be checked. Possible faults that appear must be removed for the future in a clear and documented procedure.
Further, local health authorities can also conduct inspections. Eg. in Hamburg Behörde für Gesundheit und Verbraucherschutz, authority for health and consumer protection supervises at regular intervals clinical tests on medicine for humans according to corresponding paragraphs of the law governing the manufacture and prescription of drugs and the GCP-decree (ordinance), should the situation arise, according to the medicine product law.