EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Institution or Investigator 1.5
Appears in 1 contract
Samples: smlouvy.gov.cz
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Institution or Investigator 1.5will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and privacy, as well as all
Appears in 1 contract
Samples: Trial Agreement
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution Provider and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution Provider and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead Sponsor and the EC before such individual is allowed to be screened for participation in the Trial. Institution Provider or Investigator 1.5will ensure that the ICF complies in form and
Appears in 1 contract
Samples: Trial Agreement
EC Approvals and Informed Consent Form. Prior to the commencement of the Trial at the Trial Site, Institution and Investigator will obtain approval for the Trial, including approval of the Protocol, informed consent form and, if applicable, pediatric assent form (collectively, “ICF”) and any amendments to any of the foregoing, from the applicable Ethics Committee (“EC”) in accordance with applicable laws, rules and regulations. Institution and Investigator will obtain from each individual (or such individual’s legal representative) who is to be screened for participation in the Trial, a properly executed ICF, as approved by Gilead and the EC before such individual is allowed to be screened for participation in the Trial. Institution or Investigator 1.5will ensure that the ICF complies in form and content with applicable laws, regulations and guidance including ICH-GCP and laws governing data protection and
Appears in 1 contract
Samples: Clinical Trial Agreement