Subjects. Prior to screening a Study partici- pant ("Subject") for enrollment into the Study, Institution and Investigator shall obtain from such Subject or Subject's legal repre- sentative, a signed patient consent form meeting all requirements under Applicable Law and previously approved by IRB/IEC and Idorsia ("ICF"). Institution or Investigator shall promptly, but in any event within five (5) work- ing days after discovery of a Study participant receipt of the drug, report to Idorsia and the IRB/IEC any failure to obtain a signed ICF from such Subject. 1.6
Appears in 2 contracts
Samples: Trial Agreement, smlouvy.gov.cz
Subjects. Prior to screening a Study partici- pant ("Subject") for enrollment into the Study, Institution and Investigator shall obtain from such Subject or Subject's legal repre- sentative, a signed patient consent form meeting all requirements under Applicable Law and previously approved by IRB/IEC and Idorsia ("ICF"). Institution or Investigator shall promptly, but in any event within five (5) work- ing days after discovery of a Study participant Subject receipt of the Study drug, report to Idorsia and the IRB/IEC any failure to obtain a signed ICF from such Subject. 1.6
Appears in 1 contract
Samples: Trial Agreement
Subjects. Prior to screening a Study partici- pant ("Subject") for enrollment into the Study, Institution and Investigator shall obtain from such Subject or Subject's legal repre- sentativerepresentative, a signed patient consent form meeting all requirements re- quirements under Applicable Law and previously previ- ously approved by IRB/IEC and Idorsia ("ICF"). Institution or ICF Investigator shall promptly, but in any event within five (5) work- ing working days after discovery of a Study participant receipt of the drug, report to Idorsia and the IRB/IEC any failure to obtain ob- tain a signed ICF from such Subject. 1.6
Appears in 1 contract
Samples: smlouvy.gov.cz