regulatory environment conducting clinical
studies with medicinal products and medical devices are strictly
regulated. As well as analysing human biosamples in
written procedures, e.g. SOPs and Working Instructions should
ensure that all related activities are performed respecting
applicable guidelines and legal regulations. Compliance with
the Quality Management System will be checkerd by Audits
on regular basis.
study data must be handled in compliance with suitable regulations
(e.g. 21 CFR Part 11, GAMP, PIC/S).
Therefore, systems and applications for electronic data capture
(EDC), processing, storage and archiving must be validated to
ensure that, e.g. changes on electronic date are only possible
if these are
documented and tracked (e.g. Audit
or Edit Trails). Data
security and data protection of all trial documents and study
data must be guaranteed.