Within the Department of Non-Commercial Clinical Research the Academic CRO Unit (Contact Research Organization) is being established. Its intended task will be a comprehensive support of non-commercial academic research.
In the Unit’s range of activities are:
- analysis/validation of clinical research protocols,
- preparation of documentation necessary to obtain consents to conduct the study (Bioethics Commission, URPL, EV),
- conducting audits and verification of potential partners and research units,
- monitoring of non-commercial research in units,
- maintenance of documentation: creating (TMF), SOP, test-specific instructions,
- negotiating contracts with units, also in cooperation with the Clinical Research Implementation Unit,
- pharmacovigilance: keeping a register of adverse reactions and reporting them to Bioethics Commission and EUDRAVIGILANCE base, as well as preparing annual reports regarding patients’ safety,
- quality management in research units (compliance with legal acts, procedures of the MUG, and GCP).
Patrycja Kondej-Welzman, M.A.
Phone: 58 349 27 74