Subjects. Prior to screening a Study participant ("Subject") for enrollment into the Study, Institution and Investigator shall obtain from such Subject or Subject's legal representative, 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) working 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.
Appears in 3 contracts
Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement
Subjects. Prior to screening a Study participant ("Subject") for enrollment into the Study, Institution and Provider shall ensure that Investigator shall obtain obtains from such Subject or Subject's legal representative, a signed patient consent form meeting all requirements under Applicable Law and previously approved by IRB/IEC and Idorsia Actelion ("ICF"). Institution or Investigator Provider shall promptly, but in any event within five (5) working 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.1.5
Appears in 1 contract
Samples: Healthcare Agreement
Subjects. Prior to screening a Study participant ("Subject") for enrollment into the Study, Institution and Investigator shall obtain from such Subject or Subject's legal representative, 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) working days after discovery of a Study participant receipt Subjectreceipt of the drug, report to Idorsia and the IRB/IEC any failure to obtain a signed ICF from such Subject.
Appears in 1 contract
Samples: Clinical Trial Agreement