Comparator Drug definition

Comparator Drug means a placebo or comparator drug.
Comparator Drug means a placebo or comparator drug. „Srovnávací lék“ znamená placebo nebo srovnávací lék.
Comparator Drug means [*], or any other pharmaceutical product used as a comparator drug as the Parties may mutually agree after the Effective Date, for use in the Clinical Studies conducted for the Development of the Product in the Development Indication in accordance with the Development Plan.

Examples of Comparator Drug in a sentence

  • Any other use of Sponsor Drug or Comparator Drug constitutes a material breach of this Agreement.

  • Institution and Principal Investigator will use Sponsor Drug or Comparator Drug only as specified in the Protocol.

  • Institution will return and/or destroy any unused Sponsor Drug or Comparator Drug, as applicable, at Sponsor’s expense.

  • Institution and Principal Investigator will adhere to Applicable Law requiring careful custody and dispensing of Sponsor Drug or Comparator Drug, as well as appropriate documentation of such activities.

  • Institution and Principal Investigator will not charge a Trial Subject or third-party payer for Sponsor Drug or Comparator Drug or for any services reimbursed by Sponsor or its designee under this Agreement.

  • Institution and Principal Investigator will maintain appropriate control of supplies of Sponsor Drug or Comparator Drug and will not administer or dispense it to anyone who is not a Trial Subject, or provide access to it to anyone except Research Staff.

  • Neither the Institution nor the Principal Investigator will directly or indirectly seek or receive compensation from Trial Subjects or third-party payers for any material, treatment or service that is required by the Protocol and provided or paid by Sponsor or its designee, including, but not limited to, Sponsor Drug, Comparator Drug, Trial Subject screening, infusions, physician and nurse services, diagnostic tests, and Sponsor Drug and/or Comparator Drug administration.

  • Institution will use Sponsor Drug or Comparator Drug only as specified in the Protocol.

  • Institution and Principal Investigator will maintain appropriate control of supplies of Sponsor Drug or Comparator Drug and will not administer or dispense it to anyone who is not a Trial Subject, or provide access to it to anyone except subinvestigators or Trial research staff.

  • Institution will return and/or destroy, as applicable and at Sponsor’s expense, any unused Sponsor Drug or Comparator Drug.


More Definitions of Comparator Drug

Comparator Drug means any investigational or marketed product or placebo which is used as a reference in a clinical trial.
Comparator Drug means a placebo or comparator drug. 1.4 “CRF” shall mean a Case Report Form, which is a paper or electronic questionnaire used to collect all data generated in the course of the Trial for each Trial Subject. 1.5 “CRO” shall mean a Clinical Research Organization that is or will be engaged by Sponsor. Currently it is PSI CRO AG, Xxxxxxxxxxxxx 000x, 0000 Xxx, Xxxxxxxxxxx and its affiliates as described in the preamble. 1.6 “Effective Date” shall mean the last date of signature of the Agreement by the Parties. 1.7 “Equipment” shall have the meaning set forth in Section 23. 1.8 “Force Majeure” shall have the meaning set forth in Section 31. najnovšom znení a všetky ďalšie platné európske a národné zákony, pravidlá a nariadenia, vrátane, okrem iného povinných lokálnych zákonov, ktoré majú inak prednosť pri realizácii Skúšania podľa tejto Zmluvy, ako aj súvisiace Protikorupčné zákony (ako sa definujú nižšie). Aby sa predišlo pochybnostiam, Zmluvné strany potvrdzujú, že Platné zákony ďalej zahŕňajú zákony, ktorými xx xxxxx realizácia klinických skúšaní na Slovensku, predovšetkým zákon č. 362/2011 Zb. O liekoch a zdravotníckych pomôckach, v znení neskorších predpisov, a zákon č. 576/2004 Zb. O zdravotnej starostlivosti a službách súvisiacich s poskytovaním zdravotnej starostlivosti, v znení neskorších predpisov a platné zákony, ktorými xx xxxxx ochrana údajov na Slovensku, predovšetkým zákon č. 18/2018 Zb. O ochrane osobných údajov, v znení neskorších predpisov).
Comparator Drug. Comparator Drug means unexpired comparator drugs used for Global Development Plan activities after the Effective Date.
Comparator Drug means a placebo or comparator drug. Výklad pojmov Ak sa výraz kedykoľvek v tejto Zmluve napíše veľkým písmenom, má taký význam, ako sa uvádza nižšie. Množné xxxxx každého pojmu má zodpovedajúci význam. 1.1 „Platné právne predpisy“ znamenajú Smernicu o klinických skúšaniach 2001/20/EK, Nariadenie o klinických skúšaniach (EÚ) 536/2014 – v rozsahu, ktorý je uplatniteľný pre toto Skúšanie, Smernicu GCP 2005/28/EC, Všeobecné nariadenie o ochrane údajov (EÚ) 679/2016 a všetky následné verzie vyššie uvedených dokumentov, ako aj všetky uplatniteľné národné zákony, v ktorých sa uvádzajú ustanovenia vyššie uvedeného, GCPMP/ICH/135/95 Usmernenie o Správnej klinickej praxi, v znení neskorších predpisov, Helsinskú deklaráciu z roku 1964 v jej najnovšom znení a všetky ďalšie platné európske a národné zákony, pravidlá a nariadenia, vrátane, okrem iného povinných lokálnych zákonov, ktoré majú inak prednosť pri realizácii Skúšania podľa tejto Zmluvy, ako aj súvisiace Protikorupčné zákony (ako sa definujú nižšie). Aby sa predišlo pochybnostiam, Zmluvné strany potvrdzujú, že Platné zákony ďalej zahŕňajú zákony, ktorými xx xxxxx realizácia klinických skúšaní na Slovensku, predovšetkým zákon č. 362/2011 Zb. O liekoch a zdravotníckych pomôckach, v znení neskorších predpisov, a zákon č. 576/2004 Zb. O zdravotnej starostlivosti a službách súvisiacich s poskytovaním zdravotnej starostlivosti, v znení neskorších predpisov a platné zákony, ktorými xx xxxxx ochrana údajov na Slovensku, predovšetkým zákon č. 18/2018 Zb. O ochrane osobných údajov, v znení neskorších predpisov).

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