Trial Subject definition

Trial Subject means a person who is either a patient or a healthy person to whom investigational product is administered for the purposes of a clinical trial.
Trial Subject means a person enrolled to participate in the Clinical Trial according to criteria detailed in the Protocol;
Trial Subject means a patient participating in the Trial.

Examples of Trial Subject in a sentence

  • A Screen Failure is a consented Trial Subject who fails to meet the screening visit criteria and is thus not eligible for enrollment into the Trial.

  • Sponsor may discontinue Trial Subject enrollment if the total enrollment needed for a multi-center Trial has been achieved, if applicable.

  • Where practicable, Sponsor’s or CRO’s prior written consent will be obtained, unless it will compromise the integrity of the Trial or affect Trial Subject safety, in which case Sponsor will be notified as soon as practicable after the fact.

  • A Screen Failure is a consented Trial Subject who fails to meet the screening visit criteria and is thus not eligible for enrollment into the Trial (“Screen Failure”).

  • Where practicable, Sponsor’s or INC Research’s prior written consent will be obtained, unless it will compromise the integrity of the Trial or affect Trial Subject safety, in which case Sponsor will be notified as soon as practicable after the fact.


More Definitions of Trial Subject

Trial Subject means a patient recruited onto the Trial for the purpose of participation in the Trial;
Trial Subject means an individual enrolled into the Trial in accordance with the Protocol.
Trial Subject means an individual, whether a patient or not, who participates in the Clinical Trial: (a) as a recipient of the Investigational Medicinal Product or of some other treatment or product; or (b) without receiving any treatment or product, as a control.
Trial Subject means a patient participating in the Trial. „Subjekt klinického hodnocení“ znamená pacienta účastnícího se klinického hodnocení.
Trial Subject means a person enrolled to participate in the Clinical Trial according to criteria detailed in the Protocol. For the purposes of this Agreement this may also include persons identified by the Other Trial Site as potential Clinical Trial Subjects, prior to their enrolment and irrespective of whether they are enrolled if they have been identified by the Other Trial Site;
Trial Subject means a patient participating in the Trial. 2 PI, Sub-Investigators and Research Staff 2.1 PI is an employee of Institution and shall be responsible for the direction of the Trial in accordance with Applicable Law, the Protocol, Sponsor’s instructions, IEC approval and Institution’s applicable policies. The Sponsor and PI conclude a separate agreement for this purpose (“PI Agreement”). Institution may not appoint any other person as PI without Sponsor’s prior written approval. If PI is unable to perform the duties required under this Agreement, Institution and PI shall promptly notify the Sponsor in writing. If a replacement acceptable to the Sponsor is not available, this Agreement may be terminated as provided in Section 20.1.e) of this Agreement. 2.2 Institution may delegate duties and responsibilities to sub-investigators and other Institution Personnel only to the extent permitted by Applicable Law. Institution shall ensure that only individuals who are appropriately trained and qualified shall assist in the conduct of the Trial as sub-investigators or Institution Personnel. Institution shall ensure that every sub-investigator involved in the Trial will submit Sponsor a dated and signed curriculum vitae and a signed financial disclosure upon request.
Trial Subject means a patient participating in the Trial. „Klinické hodnocení“ znamená multicentrické klinické hodnocení prováděné v souladu s protokolem. „Data klinického hodnocení“ zahrnují mimo jiné CRF (či jejich ekvivalent) nebo elektronické záznamy dat, jakož i veškeré další dokumenty či materiály vytvořené pro hodnocení, a u nichž je požadováno, aby byly předloženy zadavateli nebo CRO nebo jakémukoli dodavateli třetí strany instruovaným zadavatelem, jako jsou rentgenové snímky, snímky magnetické rezonance nebo jiné typy lékařských snímků, EKG, EEG či jiné typy sledování či výtisků nebo souhrny dat. „Subjekt klinického hodnocení“ znamená pacienta účastnícího se klinického hodnocení.