Subject Confidentiality; Data Protection. Důvěrnost dat subjektů; Ochrana dat.
Subject Confidentiality; Data Protection. This section applies to the Parties’ processing of Personal Data in the context of the Services. All capitalized terms used in this section unless specifically defined herein, shall have the meaning as set out in Regulation (EU) 2016/679 (“GDPR”). Personal Data may be processed in the context of Pharmacy’s performance of the Services, and certain Personal Data may be transferred between the Parties for the purposes of fulfilling this Agreement. The Parties agree to comply with all applicable laws and regulations regarding Study subject confidentiality and data protection, including the GDPR and the Norwegian Personal Data Act including any other legislation implementing the GDPR (“Privacy Legislation”). The Parties acknowledge that Pharmacy is the Controller when Personal Data are processed in the context of pharmacy specific activities. Pharmacy specific activities include, but are not limited to (i) fulfilling documentation requirements as prescribed by law; (ii) distribution of Study Drugs; and (iii) the compounding of Study Drugs and/or ordering of infusions. Sponsor is the Controller when Sponsor determines the purposes and means of the processing, including but not limited to situations where Personal Data are used (i) in Sponsor’s own information systems; (ii) for the purposes of fulfilling obligations attributed to Sponsor under applicable law (e.g. legislation on clinical trials); and (iii) for providing access to information systems to Pharmacy personnel. Each Party is responsible for fulfilling the obligations imposed on Controllers under the Privacy Legislation for the processing of Personal Data where the respective Party is considered a Controller, including with respect to establishing a legal basis for the processing. The Parties agrees to maintain appropriate measures to ensure the confidentiality and security of the Personal Data, and enter into all reasonable undertakings in respect to safeguard the fundamental rights and the interests of the Data Subjects in accordance with the Privacy Legislation. This includes implementing appropriate technical and organizational measures, executing data processing agreements and/or international transfer agreements whenever necessary, and safeguarding any obligations to notify to the supervisory authorities and to respond to requests for exercising the data subject's rights laid down in the Privacy Legislation. Pharmacy shall promptly inform Sponsor about any Personal Data Breach concerning Personal ...
Subject Confidentiality; Data Protection. 27This section applies to the Parties’ processing of Personal Data in the context of the Services. All capitalized terms used in this section unless specifically defined herein, shall have the meaning as set out in Regulation (EU) 2016/679 (“GDPR”).
Subject Confidentiality; Data Protection. The parties agree to abide by all applicable laws and regulations regarding subject confidentiality and data protection. Hospital acknowledges that Principal Investigator shall be responsible for ensuring that all consents and authorizations required by applicable law are obtained from Study subjects, in accordance with the Clinical Study Agreement and applicable law. Where Hospital collects, retains, processes or discloses information identifying or, in combination with other information, identifiable to a living individual, including Study subjects and others, participating in or associated with the Study (“Personal Data”), in performing its obligations under this Agreement, it shall only do so in accordance with this Agreement, with all applicable laws and Sponsor’s written instructions or Hospital’s documented standard operating procedures. Hospital shall adopt appropriate safeguards to ensure the confidentiality and security of the Personal Data. Hospital shall promptly inform Sponsor about any unauthorized access to or disclosure of Personal Data (“Security Breach”), including the timing and nature of the Security Breach, and take all reasonable measures to remedy the Security Breach. Where applicable data protection laws require that the parties enter into additional agreements or undertakings, including international data transfer agreements, Hospital will undertake to ensure that all necessary agreements are implemented and in place.
Subject Confidentiality; Data Protection. 7. D ôvernosť účastníkov, ochrana údajov.
(a) Where any Institution Personnel Processes (as defined below) information identifying or, in combination with other information, identifiable to a living individual participating in or associated with the Study (“Personal Data”), the Institution shall ensure such Processing is performed only in accordance with this Agreement, all applicable Laws, including requirements pertaining to data transfer agreements, if applicable, and AbbVie’s written instructions. For the purposes of this Agreement, “Processing” (and its conjugates including, without limitation, “Process”) shall mean any operation or set of operations that is performed upon Personal Data including, without limitation, any collection, recording, retention, organization, storage, adaptation, alteration, retrieval, consultation, blocking, erasure, use, disclosure, access, transfer or destruction, whether or not by electronic means. The Institution shall maintain appropriate safeguards to ensure the confidentiality and security of the Personal Data. The parties commit that the Study will be conducted in accordance with the terms of Act 122/2003 Coll. on Personal Data Protection, as may be amended from time to time. a. Ak niektorí členovia Personálu zariadenia spracúvajú (ako to je definované nižšie) informácie, ktoré identifikujú alebo v kombinácii s inými informáciami môžu identifikovať žijúcu osobu, ktorá sa zúčastňuje Skúšania alebo s ním xx xxxxxx spojená („ Osobné údaje“), Zariadenie zabezpečí, aby sa takéto Spracúvanie vykonávalo výlučne v súlade s touto Zmluvou a všetkými platnými Právnymi predpismi vrátane požiadaviek vzťahujúcich sa na dohody o presunoch údajov (ak sa to uplatňuje) a písomnými pokynmi spoločnosti AbbVie. Na účely tejto Zmluvy bude pojem „ Spracúvanie“ (a všetky jeho tvary, okrem iného aj „ Spracovať“) znamenať akúkoľvek činnosť alebo rad činností, ktoré xx xxxxx s Osobnými údajmi, okrem iného aj ich zhromažďovanie, zaznamenávanie, uchovávanie, organizovanie, skladovanie, upravovanie, pozmeňovanie, vyhľadávanie, konzultovanie, blokovanie, vymazávanie, používanie, zverejňovanie, sprístupňovanie, presúvanie alebo likvidovanie, či už elektronickými prostriedkami alebo nie. Zariadenie bude mať zavedené primerané ochranné prvky, aby zabezpečilo dôvernosť a bezpečnosť Osobných údajov. Zmluvné strany sa zaväzujú, že skúšanie bude vykonávané v súlade so zákonom č. 122/2013 Z.z., o ochrane osobných údajov, ktorý môže v priebehu času podlieh...
Subject Confidentiality; Data Protection. Institution shall comply with all applicable Laws regarding Study subject confidentiality and data protection, including without limitation, HIPAA, HITECH, and applicable state privacy Laws, in the collection, use, storage and disclosure of PHI. Institution does not intend to provide any PHI to AbbVie, provided, however, that to the extent any Records, Study Documents, results or data of the Study or information provided to AbbVie or accessed by AbbVie may include any PHI, AbbVie shall and shall ensure that AbbVie’s representatives shall hold such information in confidence, and collect, use, store, access and disclose such PHI only in accordance with applicable Law and to the extent permitted by the applicable Subject ICF and in accordance with any reasonable instructions from Institution’s IRB that are consistent with the Protocol and such Subject ICF.
Subject Confidentiality; Data Protection. Institution shall comply with all applicable Laws regarding Study subject confidentiality and data protection, including without limitation, HIPAA, HITECH, and applicable state privacy laws, in the collection, use, storage and disclosure of protected health information, as defined in HIPAA (“PHI”). Institution does not intend to provide any PHI to Pharmacyclics, provided, however, that to the extent any Records, Study Documents, results or data of the Study or information provided to Pharmacyclics or accessed by Pharmacyclics may include any PHI, Pharmacyclics shall and shall ensure that Pharmacyclics’ representatives shall hold such information in confidence, and collect, use, store, access and disclose such PHI only in accordance with applicable Law and to the extent permitted by the applicable Subject ICF and in accordance with any reasonable instructions from Institution’s IRB that are consistent with the Protocol and such Subject ICF.
Subject Confidentiality; Data Protection. (a) Smluvní strany budou dodržovat všechny zákony týkající se utajení subjektu Studie a ochrany dat, včetně – a to bez omezení
Subject Confidentiality; Data Protection. (a) Smluvní strany budou dodržovat všechny zákony týkající se utajení subjektu Studie a ochrany dat, včetně – a to bez omezení – těch opatření, která byla uložena kontrolujícím osobám zákonem č. 101/2000 Sb. o ochraně osobních údajů v platném znění, a zákonem č. 372/2011 Sb., o zdravotních službách, v platném znění. Zkoušející bude odpovědný za to, že od každého subjektu Studie před jeho účastí ve Studii získá podpis na formuláři informovaného souhlasu a autorizačního dokumentu („ICF“). ICF musí dovolit společnosti AbbVie a jejím zástupcům, včetně CRO, zapojeným do Studie nebo hodnotícím Studii, aby měli k údajům ze Studie přístup, zpracovávali je, získávali kopie, převáděli je a ukládali. Každý ICF musí odpovídat (i) Protokolu, (ii) Harmonizovaným tripartitním pokynům pro Správnou klinickou praxi (ICH) Mezinárodní konference pro harmonizaci; (iii) všem platným zákonům a zákonným nařízením; a
Subject Confidentiality; Data Protection. The parties agree to abide by all laws and regulations regarding Subject confidentiality and data protection. INSTITUTION shall require the Principal Investigator to be responsible, on behalf of the INSTITUTION, for obtaining from each Subject prior to the Subject’s participation in a Study, a signed Informed Consent in a form approved in writing by the IRB/IEC and in conformity with XXXXXX’x guidelines set forth in the Protocol. If the Informed Consent does not include such language, INSTITUTION shall require the Principal Investigator to also obtain an authorization for ABBOTT and its representatives and other third parties involved with or evaluating a Study to access and obtain copies of Study data, which is compliant with HIPAA, XXXXXX’x guidelines and all applicable state laws. Participation in a Study shall be contingent upon execution of the aforementioned authorization. Where INSTITUTION and/or the Principal Investigator collects, retains, processes or discloses Personal Data in performing its obligations under the Master Agreement or any Statement of Work, it shall only do so in accordance with the Master Agreement or XXXXXX’x written instructions. INSTITUTION and the Principal Investigator shall adopt technical and organizational measures appropriate to prevent any unauthorized or accidental use, access or processing of Personal Data, and promptly inform ABBOTT of any unauthorized access to or disclosure of Personal Data (“Security Breach”) and provide ABBOTT with all reasonable assistance to remedy the Security Breach. Where applicable data protection laws require that the parties enter into additional agreements or undertakings, including international data transfer agreements, INSTITUTION will undertake to ensure that all necessary agreements are implemented and in place.
