Informed Consent Form definition
Informed Consent Form means a document drafted to obtain the consent of a Study Participant-BE, prior to their participation in a study, approved by the appropriate ethics committee.
Informed Consent Form or “ICF” means a document that outlines a patient’s rights during participation in a clinical trial. It also discusses the potential risks and benefits associated with participation, including all available data on previous studies. The ICF must be signed by the patient or authorized caregiver before entrance is granted into a study.
Informed Consent Form means the consent form to be filled out and signed by the Patient, a template of which is included in the User Manual and which may be modified from time to time by TiGenix or Sobi if so required by laws, regulations or necessary permits, such as for example in the event of a process change;
Examples of Informed Consent Form in a sentence
Any additional IRB fees for continuing reviews, submission of amendments, and translations of the Informed Consent Form shall be submitted to SPONSOR as required.
The Protocol and the Informed Consent Form shall not be revised without the prior written agreement of Sponsor, Nordic Bioscience and the EC.
In the event the EC requires changes in the Protocol or Informed Consent Form, such changes shall not be implemented until Sponsor and Nordic Bioscience are notified and Sponsor gives its written approval.
In the event the EC requires changes in the Protocol, Informed Consent Form or Clinical Trial recruitment procedures, such changes shall not be implemented until Sponsor and CRO are notified and the Sponsor or CRO gives its written approval.
Any potential participant who upon entrance into the treatment phases of the Study, meets all of the inclusion criteria and none of the exclusion criteria set forth in the Protocol and has signed a valid IEC/SÚKL approved Informed Consent Form.
More Definitions of Informed Consent Form
Informed Consent Form means a printed document on which an individual may
Informed Consent Form means a printed document on which an individual may signify that individual's informed consent for testing for the presence of an antibody to the human immunodeficiency virus or authorize the disclosure of any test results obtained.
Informed Consent Form means the form, reviewed and approved by the Sponsor, the Institution, IRB, and Regulatory Authorities, that each Study Participant and/or, as the case may be, her/his legal representative signs prior to enrolment in the Study indicating consent to participate in the Study on the basis of the information on the Protocol provided in said form as well as to the collection, storage and processing of a Study Participant’s personal data in relation to the Study, without the undue influence or coercion of any person directly involved in the Study, and in accordance with Applicable Laws. Intellectual Property Rights mean all present and future industrial and intellectual property rights, including without limitation patents, copyrights, trademarks, service marks (whether registered or not), domain names, meta tags, design rights, registered designs, moral rights, rights relating to computer software, database rights and rights in databases and any similar property rights, other industrial or intellectual property rights, including those subsisting in any part of the world in inventions, unregistered designs, drawings, lay-out circuit designs, computer programs, utility models, ▇▇▇▇▇ patents, trade secrets, test or development results, Confidential Information, Know-how, business names, goodwill and the style or presentation of goods or services and in applications for protection of any of the above rights subsisting anywhere in the world and any application for or right to apply for registration of any of those rights, whether presently or in the future Investigational Medicinal Product means [insert drug], a drug product or drug products whose pharmacological activity or activities will be evaluated in the Study Participants, as defined in the Protocol. Investigator’s Brochure is a compilation of the clinical and non-clinical data on the Investigational Medicinal Product(s) which are relevant to the study of the Investigational Medicinal Product in humans. IRB means the properly constituted or appointed or designated Institutional Review Board for the Institution that is responsible for approving the Protocol.
Informed Consent Form means a signed and documented form in which each Human Subject voluntarily consents or confirms his or her willingness to participate in a particular clinical trial after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. The informed consent form satisfies the requirements of ICH ▇▇, ▇▇ C.F.R. Part 46 and 21 C.F.R. Part 50. NIAID Intramural Clinical Trial Agreement (Clinical Center) NIAID ▇▇▇▇▇▇▇▇ # ▇▇-▇-▇▇▇▇
Informed Consent Form means a document to be signed by the insured person or the designee of the insured person acknowledging receipt of a copy of the terms and conditions of the external review process as provided by Title 63 O.S. Supp. 1999 Section 2528.5 and acknowledging understanding of and consent to such terms and conditions [Title 63 O.S. Supp. 1999, Section 2528.2].
Informed Consent Form means the informed consent form that is to be signed by all Subjects enrolled in the Study, together with any amendments thereto.
Informed Consent Form means the written form agreed upon by Actiniumand the Site in conformance with all applicable FDA regulations and guidances, and approved by the IRB for use in this Study.