Audits by the Sponsor. The Institution shall make available to the Sponsor (or its agent) the Study site, the Study Staff, and, subject to Applicable Law relating to patient confidentiality, all Study Materials for purposes of review and audit upon reasonable advance notice during regular business hours. Upon receipt of written notice from the Sponsor of any violations of the Protocol, this Agreement, or Applicable Law found in such audit, the Principal Investigator and the Institution shall promptly take action to correct such violations and shall provide confirmation to Sponsor of such corrective action.
Appears in 1 contract
Samples: Clinical Trial Agreement
Audits by the Sponsor. The Institution shall make available to the Sponsor (or its agent) the Study site, the Study Staff, and, subject to Applicable Law relating to patient confidentiality, and all Study Materials Documents for purposes of review and audit upon reasonable advance notice during regular business hours. Upon receipt of written notice from If the Sponsor of Principal Investigator fails to correct any violations of the Protocol, this Agreement, or Applicable Law found in such auditaudit after receiving written notice thereof, the Principal Investigator and Sponsor may provide notice to the Institution of such violations, whereupon the Institution shall promptly take action to correct such violations and shall provide confirmation to Sponsor of such corrective actionthem.
Appears in 1 contract
Samples: Clinical Trial Agreement
Audits by the Sponsor. The Institution Institution/Principal Investigator shall make available to the Sponsor (or its agent) the Study site, the Study Staff, and, subject to Applicable Law relating to patient confidentiality, all Study Materials for purposes of review and audit upon reasonable advance notice during regular business hours. Upon receipt of written notice from the Sponsor of any violations of the Protocol, this Agreement, or Applicable Law found in such audit, the Principal Investigator and the Institution shall promptly take action to correct such violations and shall provide confirmation to Sponsor of such corrective action.
Appears in 1 contract
Samples: Clinical Trial Agreement
Audits by the Sponsor. The Institution shall make available to the Sponsor (or its agent) the Study site, the Study Staff, and, subject to Applicable Law relating to patient confidentiality, all Study Materials Documents for purposes of review and audit upon reasonable advance notice during regular business hours. Upon receipt of written notice from the Sponsor of any violations of the Protocol, this Agreement, or Applicable Law found in such audit, the Principal Investigator and the Institution shall promptly take action to correct such violations and shall provide confirmation to Sponsor of such corrective action.
Appears in 1 contract
Samples: Clinical Trial Agreement