Medical Confidentiality. The Parties shall adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects. The Medical Records and any other Personal Data of a Clinical Trial Subject shall not be disclosed to the Sponsor or CRO by the Clinical Organisation, save where necessary in any of the following circumstances: 6.2.1 to the extent that the disclosure is required to satisfy the requirements of the Protocol or compliance with applicable laws; 6.2.2 for the purpose of monitoring, auditing or adverse event reporting or investigation; 6.2.3 for the purposes of investigation or defending any claim or proceeding brought by a Clinical Trial Subject in connection with the Clinical Trial; and 6.2.4 for the purpose of allowing the Sponsor to follow-up with the Clinical Trial Subject after the conclusion of the Clinical Trial. The Sponsor and CRO shall not disclose the identity of any Clinical Trial Subject to any third party save in accordance with Data Protection Laws and Guidance or as required by law, and the Clinical Organisation and the relevant Clinical Trial Subject shall be notified by the Sponsor or CRO of such intended disclosure prior to such disclosure being made, unless the Sponsor or CRO is otherwise prohibited from doing so in accordance with applicable law.
Appears in 2 contracts
Medical Confidentiality. The Parties shall adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects. The Medical Records and any other Personal Data of a Clinical Trial Subject shall not be disclosed to the Sponsor or CRO by the Clinical Organisation, save where necessary in any of the following circumstances:
6.2.1 to the extent that the disclosure is required to satisfy the requirements of the Protocol or compliance with applicable laws;
6.2.2 for the purpose of monitoring, auditing or adverse event reporting or investigation;
6.2.3 for the purposes of investigation or defending any claim or proceeding brought by a Clinical Trial Subject in connection with the Clinical Trial; and
6.2.4 for the purpose of allowing the Sponsor to follow-up with the Clinical Trial Subject after the conclusion of the Clinical Trial. The Sponsor and CRO shall not disclose the identity of any Clinical Trial Subject to any third party save in accordance with Data Protection Laws and Guidance or as required by law, and the Clinical Organisation and the relevant Clinical Trial Subject shall be notified by the Sponsor or CRO of such intended disclosure prior to such disclosure being made, unless the Sponsor or CRO is otherwise prohibited from doing so in accordance with applicable law.
Appears in 2 contracts
