Informed Consent Clause Samples
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Informed Consent. Principal Investigator shall ensure that the ICF approved by Sponsor, IEC and/or RA is signed on behalf of each Trial Subject before the first Trial related procedure starts for the Trial Subject. 8. Informovaný souhlas. Hlavní zkoušející je povinen zajistit, že před zahájením prvních postupů klinického hodnocení u subjektu klinického hodnocení bude jménem každého subjektu klinického hodnocení podepsán formulář informovaného souhlasu schválený zadavatelem, NEK a/nebo RÚ.
Informed Consent. Both of us have reviewed this Agreement with independent legal counsel. We understand the content, legal effect, and consequences of this Agreement, and we are entering into this Agreement voluntarily, free from duress, fraud, undue influence, or coercion of any kind.
Informed Consent. Informed Consent requires that: the Provider has obtained informed consent from the Donor(s) to provide Materials to the Recipient to undertake the Project as contemplated. In the event of Secondary Use of the Materials, the Donor(s) have consented thereto insofar as the Secondary Uses have been approved by the HREC. the Donor(s) have been informed that, where reasonably possible, the Provider will inform them of developments or progress made by the Recipient in the Project and which is relevant to the Donor(s) Informed Consent. the Donor(s) have been informed and have accepted that on termination of this agreement, the Material will be returned to the Provider or destroyed, or any other arrangements made, as determined by the Provider under clause 8. the Donor(s) are aware that all Materials and associated data are de-identified. Disclosure to Donor(s) has been made in the event that Materials will be released into the public domain. should the Recipient wish to conduct studies or use the Material for any other purpose than that approved by the HREC, the Provider must be notified in writing and HREC approval must first be obtained.
Informed Consent. 1.6.1 Institution/Principal Investigator undertakes to use the patient information sheet as approved by the Ethics Committee and to obtain written informed consent from each Study subject prior to inclusion or initiation of any Study specific procedures for screening according to the Protocol.
Informed Consent. Antigen Express shall prepare the patient informed consent form for the Study (which shall include provisions regarding the use of Samples in Sample Testing) in consultation with Merck (it being understood and agreed that the portion of the informed consent form relating to the Sample Testing of the Merck Compound shall be provided to Antigen Express by Merck). Any proposed changes to such form that relate to the Merck Compound, including Sample Testing of the Merck Compound, shall be subject to Merck’s prior written consent. Any such proposed changes will be sent in writing to Merck’s Project Manager and Merck’s Alliance Manager. Merck will provide such consent, or a written explanation for why such consent is being withheld, within fifteen (15) Business Days after Merck receives a copy of Antigen Express’ requested changes.
Informed Consent. The Principal Investigator shall obtain the written informed consent of each Subject prior to any screening or participation in the Study using the Informed Consent Materials (as defined in Section 11.3) and in accordance with Applicable Laws. Institution shall cause each Subject to complete an informed consent form that has been reviewed and approved in advance by SPONSOR and by an institutional review board approved by the Institution that complies with the requirements of 21 C.F.R. Part 56 (“IRB”). The Informed Consent Materials shall not be modified or amended without prior written approval of the SPONSOR and IRB.
Informed Consent. 5 Pharmacy must obtain written informed consent from the individual prior to administering the vaccine. Consent to the immunization of a child must be in writing and signed by an authorized person. The written consent must include: the name of the child, the name of one or both parents, if known, the name of any managing conservator or guardian of the child, the name of the person giving consent and the person’s relationship to the child, a statement of the nature of the medical treatment to be given, and the date the treatment is to begin.
Informed Consent. 10.1 The Provider must obtain an informed consent from the Donor(s) to provide Materials to the Recipient to undertake the Project as contemplated.
10.2 The Provider must furnish the completed consent form from the donors together with the project protocol to the HREC for approval.
10.3 The Provider must submit the informed consent form for Secondary Uses of the Material to the HREC should the need arise for Secondary Use.
10.4 The Provider must inform the donors of developments or progress made by the Recipient in the Project and which is relevant to the Donor(s) Informed Consent.
Informed Consent. 1.5 Informovaný souhlas
(a) PSI shall provide the Investigator with an Information for the Patient and template Informed Consent Form approved by the Sponsor and the RA/EC (the “Informed Consent Form”) which the investigator shall use in the Study. Changes to the Informed Consent Form shall not be implemented unless and until PSI is notified and, in full agreement with the Sponsor, gives its written approval.
(b) The Investigator shall inform each Study Subject or the Study Subject's legal representative that the Investigational Medicinal Product is being used for a clinical trial, and, prior to performing any Study-specific procedures on the Study Subject, obtain from each Study Subject an Informed Consent Form signed in accordance with the Applicable Regulatory Requirements. The Informed Consent Form shall be executed in two originals with one original provided to the Study Subject and the other
(a) PSI poskytne Hlavnímu zkoušejícímu Informace pro pacienty a vzorový Informovaný souhlas schválený Zadavatelem a RO/EK (dále jen „Informovaný souhlas“), který Hlavní zkoušející použije při provádění Studie. V Informovaném souhlase nesmí být prováděny žádné změny, pokud/dokud nebyla informována PSI a pokud/dokud PSI se souhlasem ▇▇▇▇▇▇▇▇▇▇ neposkytne písemný souhlas s těmito změnami.
(b) Hlavní zkoušející podá každému Subjektu studie nebo jeho zákonnému zástupci informace o tom, že pro klinické hodnocení se používá Hodnocený léčivý přípravek, a předtím, než u Subjektu studie začne provádět jakékoli Studijní postupy, od něj v souladu s Platnými regulačními požadavky získá podepsaný Informovaný souhlas. Informovaný souhlas bude podepsán ve dvou vyhotoveních. Jeden originál bude poskytnut Subjektu studie a druhý bude uložen v záznamech uchovávaných u Poskytovatele placed in the onsite study file (OSF). (OSF).
Informed Consent. Pharmacy must obtain written informed consent from each individual (or if the individual is incapable of consenting, the person legally responsible for the individual) prior to administering a vaccine.8 Pharmacy must ensure that each individual is informed of potential side effects and adverse reactions orally and in writing prior to administering a vaccine.9 Each individual must be provided with information on the importance of having a primary care provider, in a form or format developed by the Commissioner of Health.10