Academic CRO

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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).


Contact

Patrycja Kondej-Welzman, M.A.

E-mail: p.kondej@gumed.edu.pl

Phone: 58 349 27 74