Regulatory and Ethics
For multi-centre studies
the sponsor must designate a Coordinating Investigator who will
submit the application to his/her local Ethics Committee (EC). The
EC of the Coordinating Investigator will act as national EC and will
grant a "single vote" for Poland conc. the clinical trial
protocol and related documents as well as conc. the trial
supervision by the coordinating investigator. It also will request
the opinion of the local ECs in charge conc. the suitability of the
other trial sites/ investigators.
The clinical trial has to be notified to the "Office
for Registration of Medicinal Products, Medical Devices and Biocidal
" which will grant or refuse an authorisation
within 60 days. Any objections or request
for more information may prolong the approval process.
The insurance for patients and investigators must be concluded with an insurance company
based in Poland, or with an international insurance running a Polish
affiliate office. Terms of the insurance must be available in
Overall approval time is 60 days for all phases but collection of
documents requested by authorities and EC as financial contracts, signed protocols and permits of
hospital directors for conducting the trial may prolong the
preparation of submission.
The degree of privatisation in the medical sector is lower than e.g.
in the Czech Republic and may range up to 30 %. Therefore, a major
part of outpatients could be recruited in the respective hospitals’
Communication facilities comparable to Western Europe.
Large country, nearly no highways between major towns, fast inter-city
train system available exclusively on the axis Berlin- Warsaw and
from Warsaw to few major cities,
national flights rare and expensive.
provided in Poland
CLINMARK Clinical Research, KEN
, Warsaw, Poland
Phone: +48. 22 716 55 30 Mobile +48. 502 778842 Fax: +48. 22
Web site: www.clinmark.pl
Clinical trial authorisation and EC opinion, feasibility
selection and set-up, on-site monitoring, national project