Study Drug and Study Supplies a) The Sponsor shall provide the Institution with the Study Drug at no cost in amounts sufficient for the conduct of the Study. The Sponsor may also, at its sole discretion, provide additional materials, supplies and equipment (the “Study Supplies”). Immediately upon receipt of the Study Drug and/or any Study Supplies, the Institution shall provide Sponsor or PSI with an acknowledgement of receipt. The Institution shall maintain control of the Study Drug and the Study Supplies in accordance with:
Study Drug and Study Supplies a) PSI agrees to provide the Study Drugs at no cost to the Institution or the Investigator in amounts sufficient for the conduct of the Study. PSI may also, at its sole discretion, provide additional materials, supplies and equipment (the “Study Supplies”). The Study Drug will be always delivered to the pharmacy of the Institution in properly packed containers designated for the Study Drug and labelled in accordance with § 19 (1) (e) of Decree No. 226/2008 Coll. on Specifying Good Clinical Practice. The Study Drug will be supplied from Monday to Friday from 7:00 a.m. to 2:00 p.m. Immediately upon receipt of the Study Drug and/or any Study Supplies, the Institution and/or the Investigator shall provide PSI with an acknowledgement of receipt. The Institution and the Investigator shall maintain control of the Study Drug and the Study Supplies in accordance with: (i) Applicable Regulatory Předpokládaný počet pacientů, kteří budou Hlavním zkoušejícím zařazeni do Studie do ukončení náboru, je . Podrobná kritéria pro zařazování subjektů do Studie jsou uvedena v Protokolu. Vzhledem k tomu, že Studie je součástí multicentrického hodnocení, PSI a Zadavatel mohou kdykoli požadovat, aby Hlavní zkoušející ukončil nábor pacientů do Studie.
Study Drug and Study Supplies. 1.4 Studijní lék a Studijní materiál
Study Drug and Study Supplies a) PSI agrees to provide the Study Drug at no cost to the Institution or the Investigator in amounts sufficient for the conduct of the Study. PSI may also, at its sole discretion, provide additional materials, supplies and equipment (the “Study Supplies”). Immediately upon receipt of the Study Drug and/or any Study Supplies, the Institution and/or the Investigator shall provide PSI with an acknowledgement of receipt. The Institution and the Investigator shall maintain control of the Study Drug and the Study Supplies in accordance with: (i) Applicable Regulatory Requirements; (ii) the manner outlined in the Protocol; and (iii) any additional documents provided by PSI or the Sponsor related to the technical aspects of storage (including temperature monitoring, if applicable), preparation and/or dispensing of the Study Drug. The Study Drug will be always delivered to the pharmacy of the Institution in properly packed containers designated for the Study Drug and labelled in accordance with § 1ř (1) (e) of Decree No. 226/2008 Coll. on Specifying Good Clinical Practice. The Study Drug will be supplied from Monday to Friday from 7:00 a.m. to 2:00 p.m.
