Qualified Subject definition

Qualified Subject is a subject who, on inclusion in the treatment phase of the Study, has met all of the inclusion criteria and none of the exclusion criteria in the Protocol and has given his/her written Informed Consent to participate in the Study.
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Qualified Subject is a Study subject who, on entrance into the treatment phase of the Study, met all of the entrance criteria and none of the exclusion criteria in the Protocol, gave his or her written informed consent to participate, and was randomized in accordance with the Protocol. 3.1 „Kvalifikovaný subjekt“ je subjekt hodnocení, který při vstupu do léčebné fáze studie splnil všechna vstupní kritéria podle protokolu a žádné z kritérií pro vyřazení, poskytl svůj písemný informovaný souhlas s účastí a byl randomizován v souladu s protokolem.
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Qualified Subject is a human subject who, on enrollment into the Research Plan, has met all of the eligibility criteria and none of the exclusion criteria in the Research Plan and has given his or her written informed consent to participate in the Research Plan.
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Examples of Qualified Subject in a sentence

  • A screen failure is defined as a Qualified Subject that completes screening visit but does not enroll into the Study.

  • The Provider and/or the Investigator shall inform within a period of three (3) working days ICON and the Sponsor about any request received from a Qualified Subject, their legal representative or any other data subjects to exercise their rights to access, object, correct, or delete personal data held about him/her in the context of the Study.

  • Payments will be made on a per Qualified Subject, per visit basis for visits completed and data entered into the CRFs (“Completed Visits”), as detailed in the attached Appendix 3, excluding Study level costs and invoiceable items listed separately.

  • Payment for partially completed randomized Qualified Subject, i.e. early terminations, will be made on a per visit basis for work completed.

  • Ongoing Payments will be made on a quarterly basis on a per Qualified Subject, per visit basis based on Completed Visit data entered into the CRFs. The Payee shall receive of each payment due and shall be withheld until Study completion and resolution of all site queries, constituting the Final Payment (defined below).

  • Any disclosure of patient-identifiable information of any Qualified Subject in connection with the Quarterly Reports due under Section 3.2.3(a) or any other reporting requirements hereunder shall comply with the Health Insurance and Portability and Accountability Act of 1996 and regulations, laws and guidelines related thereto.


More Definitions of Qualified Subject

Qualified Subject is a Study Subject who, on entrance into the treatment phase of the Study, met all of the inclusion criteria and none of the exclusion criteria in the Protocol, gave his or her written informed consent to participate, and was enrolled in the Study in accordance with the Protocol. 3.1. „Způsobilým subjektem“ se rozumí subjekt studie, který při vstupu do léčebné fáze Studie splňoval všechna kritéria pro začlenění a nesplňoval žádné z kritérií pro vyloučení uvedených v Protokolu, poskytl písemný informovaný souhlas s účastí a byl zapsán do Studie v souladu s Protokolem.
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Qualified Subject is a Study Subject who, on entrance into the treatment phase of the Study, met all of the inclusion criteria and none of the exclusion criteria in the Protocol, gave his or her written informed consent to participate, and was enrolled in the Study in accordance with the Protocol. „Způsobilým subjektem“ se rozumí subjekt studie, který při vstupu do léčebné fáze Studie splňoval všechna kritéria pro začlenění a nesplňoval žádné z kritérií pro vyloučení uvedených v Protokolu, poskytl písemný informovaný souhlas s účastí a byl zapsán do Studie v souladu s Protokolem. A “Completed Subject” is a Qualified Subject that has completed all the required Study visits in accordance with the Protocol to permit evaluation and whose CRF has been completed and accepted as satisfactory by Sponsor. „Subjektem, který dokončil studii“ se rozumí Způsobilý subjekt, který absolvoval všechny požadované návštěvy v rámci Studie v souladu s Protokolem umožňující hodnocení a jehož CRF byl vyplněn a přijat Zadavatelem jako uspokojivý.
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Qualified Subject is a Study Subject who, on entrance into the treatment phase of the Study, has met all of the entrance criteria and none of the exclusion criteria in the Protocol, has given his or her written informed consent to participate, and was enrolled in accordance with the Protocol. 2.1 „Způsobilý subjekt“ je subjekt hodnocení, který ▇▇▇ ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ hodnocení splňuje všechna vstupní kritéria a nesplňuje žádné vylučující kritérium uvedené v protokolu, poskytl písemný informovaný souhlas s účastí a byl zařazen do klinického hodnocení v souladu s protokolem.
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