Common use of Access to Study Data Clause in Contracts

Access to Study Data. MSK and Investigator-Sponsor will ensure that Company is named in the Informed Consent Form(s) (as defined in Section 5 below) and in the HIPAA authorization form(s) or analogous documents if signed separately from the Informed Consent Form (“HIPAA Authorization(s)”) (each, a “Consent Document”), as parties to whom Study subjects’ protected health information (as that term is defined in HIPAA) (“PHI”) may be disclosed in connection with the Study, and that such Consent Document(s) will permit Company and its authorized designees access to Study subjects’ PHI as may be necessary to audit the Study and to use the Study data and Biological Samples (defined in Section 5 below) for the purposes of performing the applicable Study. The Company will not a) use PHI except for purposes of the Study and as authorized by Study subjects; b) disclose Subject identifying information or PHI to any third party unless required to do so by law, regulation, government order, or pursuant to a written request by a Study subject; or c) maintain or dispose of PHI in an unsecure manner. The Company will immediately notify MSK after discovery or suspicion by Company that any Study subject PHI is improperly used, copied, stolen or removed by anyone or that any suspected or confirmed security incident has occurred involving a breach of security, intrusion or unauthorized use of Study subject PHI.