Study Subjects definition

Study Subjects means a person (or persons) who, in accordance with the Protocol, is (or are): (a) eligible to be enrolled in the Study; and (b) enrolled in the Study.

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Study Subjects means any patient that has consented to and is enrolled in a Sponsored Clinical Trial.

Study Subjects means those subjects enrolled in the Study which meet all Protocol eligibility requirements and protocol procedures. Subjekty studie znamenají pacienty zařazené do Studie, kteří splňují veškerá kritéria pro zařazení stanovená Protokolem.

Examples of Study Subjects in a sentence

• The Protocol may be modified only by a written amendment, approved by [Xx xX] and the responsible IRB/IEC, if applicable (“Amendment”) except, as described in the Protocol, for emergency changes necessary to protect the safety of the Study Subjects (as defined in Section 4, Subject Enrollment).

• The second payment shall be paid for duly carrying out activities 3 and 4, according to the table below, for all Study Subjects enrolled in the centre.

• If there is any conflict between this Agreement and the Protocol, the Protocol will control as to any issue regarding treatment of Study Subjects, and the Agreement will control as to all other issues.

• Because the Study is an observational study involving Study Subjects who are receiving prescribed treatment with the [Xx xX] Product as part of their standard medical care, an adverse reaction to the [Xx xX] Product would not be a Research Injury.

• Institution and [Xx xX] agree that, as between them, Institution is best able to manage requests from Study Subjects for access, amendment, Transfer, restriction, or deletion of Personal Data.

• Institution will provide CRO an opportunity to review and approve the content of any Study recruitment materials directed to potential Study Subjects before such materials are used, if any.

• Sponsor will promptly report to the Site, the EC, and IQVIA, any finding that could affect the safety of Study Subjects or their willingness to continue participation in the Study, influence the conduct of the Study, or alter the EC approval to continue the Study.

• Because this Agreement relates to a clinical study, there will be acceptable safeguards employed in such an audit to ensure confidentiality and protect the privacy of the Study Subjects.

• The Sponsor’s liability to reimburse the Institution under this provision shall not be limited to the amount payable under any insurance required to be carried by Sponsor but shall extend to the full amount of the Institution’s actual damages in the amount of Study Subject’s claim or of Study Subject's legal representative's claim successfully claimed under Czech legal order.

• The payment will be paid in instalments as follows: The first payment will be paid for duly carrying out activities 1 and 2 according to the table below for all Study Subjects included in the centre.

More Definitions of Study Subjects

Study Subjects means patients participating in the Study. 1.16 „Studijní subjekty“ znamenají pacienty, kteří se účastní Studie.

Study Subjects the individuals who voluntary participate in the clinical trial. Zaměstnanci Místa provádění klinického hodnocení: (sub)výzkumní pracovníci a výzkumný personál Místa provádění klinického hodnocení. Subjekty studie: osoby, které se dobrovolně účastní klinického hodnocení. Site staff: Name; contact details; personal data that is part of the investigator’s current curriculum vitae (such as professional qualification, education, employment); financial information.

Study Subjects. Pseudonymized data of study subjects involved in the clinical trial, these data include the following categories: - health data; - biological samples Sensitive data transferred (if applicable) and applied restrictions or safeguards that fully take into consideration the nature of the data and the risks involved, such as for instance strict purpose limitation, access restrictions (including access only for staff having followed specialised training), keeping a record of access to the data, restrictions for onward transfers or additional security measures. - Minimalization, data collection only contains the data that is specified in the study protocol. Zaměstnanci Místa provádění klinického hodnocení: Jméno; kontaktní údaje; osobní údaje, které jsou součástí aktuálního životopisu Zkoušejícího (např. odborná kvalifikace, vzdělání, zaměstnání); finanční informace. Subjekty studie: Pseudonymizované údaje subjektů studie zapojených do klinického hodnocení, tyto údaje zahrnují následující kategorie: - zdravotní údaje; - biologické vzorky Předávané citlivé údaje (je-li to relevantní) a uplatňovaná omezení nebo ochranná opatření, která plně zohledňují povahu údajů a související rizika, jako je například přísné omezení účelu, omezení přístupu (včetně přístupu pouze pro pracovníky, kteří absolvovali specializované školení), vedení záznamů o přístupu k údajům, omezení pro další předávání nebo dodatečná bezpečnostní opatření.

Study Subjects means an individual who participates in a Clinical Study as a recipient of Study Drug(s).

Study Subjects patients participating in the Study.