Regulatory & Ethical submission
All studies conducted in Poland must be presented to the regulatory/competent authority and an Independent Ethics Committee (IEC) for approval. The submission to the regulatory authority and ethics committee can be done in parallel according to the EU Guidelines.
Independent Ethics Committee (IEC)
Our applicable IEC is the Bioethics Committee by the Regional Chamber of Physicians in Warsaw. Submissions to the IEC typically takes place 2 weeks before the scheduled meeting (3 weeks for multicenter studies). Our local IEC in Warsaw meets every 2 weeks, the replies are received within 1 week after the meeting.
Regulatory/Competent Authority (RA)
The decision of the Regulatory Authority is expected within 60 days upon approval of complete study documentation. If no questions are raised by the RA, an implicit approval takes place.
In general, the regulatory authority and IEC has standard response times defined by law. Biokinetica can support meeting these timelines by submitting high quality documentation. We have collected and evaluated all comments received from previous submissions over the years. Applying this experience helps avoid time delays that could be caused through additional information requests as thorough and detailed documentation is the key to approval.
Once both bodies have approved the study, the clinical part is initiated with first subject first visit, (FSFV) within one week upon receiving final approvals.