Study Documents and Drug Supplies Sample Clauses

Study Documents and Drug Supplies. 1.7 Dokumentácia Štúdie a zásobovanie liečivom SPONSOR or the SPONSOR’s designee shall ensure appropriate and timely supply of the documents and Study Drugs necessary for the performance of the Study. The Study Drug shall be in accordance with Sec. 43 i) of Act No. 362/2011 Coll., on Drugs, supplied to Institution’s pharmacy. Institution hereby undertakes to ensure that handling with the Study Drug be performed in compliance with Protocol, Instructions, pursuant to all relevant generally binding legal regulations, and the Good Pharmacy Practice. Principal Investigator hereby undertakes to draw the Study Drug from Institution’s pharmacy in compliance with the Protocol and in doses required for each individual Study subject visit. The Site hereby warrants that it shall: (a) keep a written inventory of any clinical supplies, equipment and Study Drug provided by SPONSOR or PAREXEL according to the Protocol or the Instructions;
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Study Documents and Drug Supplies. SPONSOR or the SPONSOR’s designee shall ensure appropriate and timely supply of the documents and Study Drugs necessary for the performance of the Study. For the return of the unused Study Drug and trial-related supplies following completion of the Study, the Site shall adhere to the instructions outlined in the Protocol and/or the ISF.. The Institution and the Principal Investigator hereby warrant that they shall: a) account for all clinical supplies (including the Study Drug) provided by SPONSOR or PAREXEL and keep a written inventory of any clinical supplies and equipment supplied by SPONSOR or PAREXEL according to guidelines provided by the SPONSOR; b) use Study Drug solely for the Study, documenting each dispensing and to return all unused clinical (except in case local destruction was agreed on and documented – see art. e) bellow) or other supplies provided by SPONSOR or PAREXEL within 60 days upon conclusion of the Study; c) retain all necessary records and documents about the Study as required by applicable regulatory requirements, this Agreement, and/or the Protocol;

Related to Study Documents and Drug Supplies

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