Currently, while submitting CTA, Sponsor has to attach signed agreements with all Investigators and sites.
We all know how time-consuming it is to negotiate contracts and budget especially with big hospitals where the contacts goes from hands to hands to check it and find the most favorable conditions for either parties.
Polish legislator decided to overtake the Regulation 536/2014 and help Sponsors to submit CTAs faster and, thanks to that, start trials faster.
The work on the amendment to the polish Pharmaceutical Law assuming that the sponsor will no longer attach the agreements concerning the clinical trial concluded between the parties participating in the clinical trial to the application for the initiation of a clinical trial is in the process of being finalized in Parliament.
Instead, the sponsor shall accompany the application:
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a brief description of the financing of the clinical trial;
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information on financial transactions and compensation paid to subjects and investigators or trial sites where the clinical trial is conducted for participation in the clinical trial; and
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a description of any other agreement between the sponsor and the trial site where the clinical trial is conducted.
All the above annexes will also serve as a basis for the Bioethics Committee to issue an opinion on a clinical trial.
The change is intended to result in a greater number of clinical trials being conducted in Poland.
The new regulations on clinical trials are planned to come into force 3 months after the date of publication of the amending act in the Journal of Laws.