Access to Study Data Sample Clauses
The 'Access to Study Data' clause defines the rights and procedures for parties to obtain and review data generated during a study. Typically, it outlines who can access the raw or processed data, under what conditions, and any confidentiality or data protection requirements that must be observed. For example, it may specify that sponsors, investigators, or regulatory authorities are permitted to review study results or underlying datasets. This clause ensures transparency, facilitates regulatory compliance, and helps resolve disputes by clarifying data ownership and access rights.
Access to Study Data. Subject to the provisions of Sections 8.1, each Party shall have access to all Combined Therapy Study Data, Recipient Study Data and BMS Study Data (including de-identified patient records). The relevant Party shall make such Study Data in its possession available to the other Party within a reasonable period, not to exceed [ ]*, after such Study Data is available to or generated by the applicable Party.
Access to Study Data. Subject to the provisions of Sections 5.1, and the Pharmacovigilance Agreement, each Party shall have access to all Study Data (including, but not limited to, de-identified patient records) as soon as such Study Data is available to or generated by the Party responsible for generating or collecting such Study Data.
Access to Study Data. Subject to the provisions of Sections 2.2, 5.1(a)(xvi) and 5.1(a)(xvii), each Party and BMS shall have access to all Combined Therapy Study Data (including de-identified patient records) as soon as reasonably practicable after such Study Data is reasonably available to or generated by the Party responsible for generating or collecting such Study Data.
Access to Study Data. Subject to the provisions of this Article 7, each Party shall have access to all Study Data (including de-identified patient records) as and to the extent allowed in Trial Site agreements (which agreements [***]). Olema shall make such Study Data in its possession available to Novartis on a [***] basis within a reasonable period of time, but not to exceed [***], after [***].
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.
Access to Study Data. In accordance with the terms and conditions of this Agreement, each Party shall have access to all Study Data (including the results of testing of Samples (including, but not limited to, de-identified patient records) pursuant to the Combined Therapy Protocol) in a timely manner.
Access to Study Data. Subject to the provisions of Sections 8.1, each Party shall have access to all Study Data (including de-identified patient records), and as and to the extent allowed in [***], the study protocol and applicable regulations. The Recipient shall make such Study Data in its possession available to BMS within a reasonable period of time, but not to exceed [***] after the [***] in which such Study Data is available to the Recipient.
Access to Study Data. Upon prior written request to Institution, at mutually agreeable times during Institution’s regular business hours, and subject to the terms of this Agreement and Applicable Law, Company or its agents may access Institution’s Study data in the form in which it is available, except that direct identifiers of any Study subject, including, but not limited to. Study subject’s name, birth date, street address, telephone, social security or health plan beneficiary numbers (“Direct Identifiers”) shall not be made available to Company. In the event Study data contains Direct Identifiers, such Direct Identifiers shall be redacted. Company shall be responsible for all costs to Institution for making such Study data available, including any costs associated with redaction.
Access to Study Data. Institution shall provide Merck reasonable access to the Study Data and shall, at Merck’s expense, provide copies of the Study Data (including, but not limited to, in the case of a clinical trial, a Clinical Trial Report meeting generally accepted quality standards as outlined by the ICH Guidelines for structure and content of 7.4 Přístup k Datům z. studie Zdravotnické zařízení poskytne společnosti Merck přiměřený přístup k Datům ze studie a na náklady společnosti Merck poskytne kopie Dat ze studie (včetně ale bez omezení, v případě klinické studie, Zprávy o provádění studie splňující obecně přijímané standardy kvality navržené v pokynech ICH pro strukturu a obsah klinické clinical study) to Merck for Merck’s and its affiliates use for any purpose. All Study Data generated in the performance of the Study shall be the property of Institution, subject to Merck’s right to use the Study Data. studie) společnosti Merck pro jakékoli použití společností Merck a jejími pobočkami. Veškerá Data ze studie vytvořená při provádění studie budou vlastnictvím Zdravotnického zařízení, budou podléhat právu na využití Dat týkajících se studie společností Merck.
Access to Study Data. In accordance with the terms and conditions of this Agreement and the Pharmacovigilance Agreement, each Party shall have access to all Study Data and results of the PD-L1 Expression Testing of Samples and PVRIG Inhibitor Biomarker Testing of Samples (including, but not limited to, de-identified patient records) in a timely manner in accordance with a data sharing plan adopted by the JDC under Section 2.4(s) and consistent with Section 5.1(a)(xv). [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.