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. 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. 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. 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. 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. 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
Informed Consent. Principal Investigator will obtain a written informed consent for each Study Subject and will maintain a signed original of that consent in that Study Subject’s record. CRO and/or Pfizer will provide a template informed consent document for the Study which has been approved by the IEC and SUKL. Institution and Principal 7.1 Informovaný souhlas. Hlavní zkoušející získá informovaný souhlas od každého subjektu studie a uloží podepsaný stejnopis tohoto souhlasu v záznamech příslušného Subjektu studie. CRO nebo společnost Pfizer poskytne předlohu dokumentu informovaného souhlasu pro studii, která byla schválena EK a SÚKL. Instituce a Hlavní zkoušející nesmí Investigator must not make any changes to this document with the prior written approval of the CRO or Pfizer (including any revisions made during the course of the Study) before the revised informed consent document is used for the Study. The Institution and Principal Investigator must not recruit potential subjects to participate in the Study, commence the research covered under this Agreement, or administer the Investigational Drug (as defined below) to the Study Subjects unless and until a valid informed consent has been obtained from each Study Subject. provádět žádné změny tohoto dokumentu, aniž by obdrželi předchozí písemný souhlas CRO nebo společnosti Pfizer dříve, než upravený dokument informovaného souhlasu použijí pro Studii (včetně jakýchkoli úprav provedených během Studie). Instituce a Hlavní zkoušející nesmí provádět nábor potenciálních Subjektů pro účast ve Studii, zahájit výzkum, na který se vztahuje tato Smlouva, nebo podávat hodnocené léčivo (tak, jak je definováno níže) Subjektům studie, dokud nebyl získán platný informovaný souhlas od každého Subjektu studie.
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 each individual (or if the individual is a minor, from the individual’s parent or guardian) prior to administering a vaccine. The informed consent form must contain check-off boxes which authorize or prohibit Pharmacy from sending copies of the individual’s vaccine documentation to the individual’s primary care provider. The informed consent form must specify that the individual’s failure to select one of the two check-off boxes will result in the individual’s vaccine documentation being sent to the individual’s primary care provider, if identified.
Informed Consent. The nature, purpose and potential risk of the study as well as the action of the BL-1040 myocardial implant will be explained to all patients both verbally and in writing. They will be given adequate time to consider the study before signing the consent form. Their questions will be actively encouraged. They will be informed that they may withdraw from the study at any time. This information is documented in the protocol and participants in the study will sign a consent form confirming that they have read and understood it; no study activities will take place until the consent form has been signed. They will also be given a Patient Information Sheet and copy of the consent form.
