Institution and Principal Clause Samples

Institution and Principal. Investigator represents, warrants and covenants that Personal Information related to Trial Subjects, when supplied to ▇▇▇▇▇▇▇ and/or CRO, will be pseudonymized to replace any information that directly identifies a Trial Subject with a subject identification code. Principal Investigator will not provide ▇▇▇▇▇▇▇ or CRO with the key or code that 6.

Institution and Principal. Investigator shall ensure that: 1.

Institution and Principal. Investigator represents, warrants and covenants that Personal Information related to Trial Subjects, when supplied to ▇▇▇▇▇▇▇ and/or CRO, will be pseudonymized to replace any information that directly identifies a Trial Subject with a subject identification code. Principal Investigator will not provide Janssen or CRO with the key or code that enables Trial Subjects to be re-identified. Institution and Principal Investigator will notify ▇▇▇▇▇▇▇ and/or CRO immediately if Institution and/or Principal Investigator discovers that any Data (defined in Section 7.1) concerning Trial Subjects provided to ▇▇▇▇▇▇▇ and/or CRO does not satisfy this requirement. Principal Investigator will cooperate with all Janssen and/or CRO requests to 6.3.3 Poskytovatel a hlavní zkoušející vyjadřují, zaručují a zavazují se, že osobní informace týkající se subjektů hodnocení, pokud jsou dodány společnosti Janssen a/nebo CRO, budou pseudonymizovány nahrazením informací, které přímo identifikují subjekt hodnocení, identifikačním kódem subjektu. Hlavní zkoušející neposkytne společnosti Janssen ani CRO klíč nebo kód, který umožňuje subjekty hodnocení znovu identifikovat. Poskytovatel a hlavní zkoušející ihned vyrozumí společnost Janssen a/nebo CRO, jestliže poskytovatel a/nebo hlavní zkoušející zjistí, že údaje (definované v bodě 7.1) týkající se subjektů hodnocení poskytnuté společnosti Janssen a/nebo CRO tento požadavek nesplňují. Hlavní zkoušející bude spolupracovat na mitigate any harm resulting from any such disclosure of Data. In such an event, Institution and Principal Investigator will deliver corrected Data to Janssen and/or CRO as promptly as possible at no extra expense to Janssen and/or CRO. uspokojení všech požadavků společnosti Janssen a/nebo CRO na zmírnění újmy, která je důsledkem takového sdělení údajů. V takovém případě poskytovatel a hlavní zkoušející dodají opravené údaje společnosti Janssen a/nebo CRO co nejdříve bez dodatečných výdajů pro společnost Janssen a/nebo CRO.

Institution and Principal. Investigator each shall conduct and require, subinvestigator(s), and Institution’s other employees, subcontractors and agents performing services related to the Study (collectively, “Institution Personnel”) to conduct the Study in accordance with: (i) this Agreement; (ii) the Protocol; (iii) all written instruction provided by or on behalf of AbbVie; and (iv) all applicable laws and regulations and industry codes of practice (collectively “Law(s)”), including without limitation, anti-bribery and anti-corruption laws, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E6 Good Clinical Practice (“ICH-GCP”), the Act on Pharmaceuticals No. 378/2007 Sb., as amended (“Act on Pharmaceuticals”), the Act on Health Care Services No. 372/2011 Sb., as amended (“Health Care Services Law”), Decree No. 226/2008 Sb., as amended, on Good Clinical Practice and Detailed Conditions of Clinical Trials on Medicinal Products, Decree No. 84/2008 Sb. on Good Pharmacy Practice, as amended (“Good Pharmacy Practice”), Decree No. 86/2008 Sb. on Good Laboratory Practice in the Area of Medicines, Act No. 110/2019 Sb. on Processing of Personal Data, the EU General Data Protection Regulation (2016/679) and related data protection laws (“Data Protection Law(s)”) and other data protection and privacy laws, as each may be amended, from time to time. In furtherance of the foregoing obligations, AbbVie shall ensure that the State Institute for Drug Control (“SUKL“) and an Ethics Committee (“EC”) established and constituted in accordance with applicable Laws approves and oversees the conduct of the Study. AbbVie shall notify SUKL and EC of (i) the date and place of commencement of the Study within sixty (60) days from its start in the Czech Republic and (ii) the introduction of substantial amendments to the Protocol as required by applicable regulations. Institution and Principal Investigator shall observe the procedures set forth for recording and reporting data as required by applicable regulations. a. Zdravotnické zařízení a Hlavní zkoušející budou provádět Studii v souladu s následujícími ustanoveními, jejichž dodržení budou vyžadovat i na dalších zkoušejících a dalších zaměstnancích, subdodavatelích a zástupcích Zdravotnického zařízení spojených se Studií (společně „Personál zdravotnického zařízení“). Studie se bude provádět v souladu s (i) touto Smlouvou, (ii) Protokolem, (iii) všemi písemnými pokyny poskytnutými společnos...

Institution and Principal. Investigator represents, warrants and covenants that Personal Information related to Trial Subjects, when supplied to Janssen, will be pseudonymized to replace any information that directly identifies a Trial Subject with a subject identification code. Principal Investigator will not provide Janssen with the key or code that enables Trial Subjects to be re-identified. Institution and Principal Investigator will notify Janssen immediately if Institution and/or Principal Investigator discovers that any Data (defined in Section 7.1) concerning Trial Subjects provided to Janssen does not satisfy this requirement. Principal Investigator will cooperate with all Janssen requests to mitigate any harm resulting from any such disclosure of Data. In such an event, Institution and Principal Investigator will deliver corrected Data to Janssen as promptly as possible at no extra expense to Janssen.

Institution and Principal. Investigator shall conduct the Study and cause any Study Staff to act, and conduct the Study in accordance with this Agreement, the Protocol (including any subsequent amendments), the Investigator’s brochure all written Study Instructions, Applicable Law including but not limited to Act No. 378/2007 Coll., on Pharmaceuticals, as amended and Decree No. 226/2008 Coll. on good clinical practice and detailed conditions of clinical trials on medicinal products, as amended and any professional standards applicable to their professional industries as in force at the time of performance of the Study (e.g. International Conference on Harmonization-Good Clinical Practice) or as they may be amended or replaced at any time. Institution shall ensure Principal Investigator fulfils his/her obligations under this Agreement and shall be responsible for any failure by Principal Investigator to comply with the responsibilities and obligations hereunder. 1.1. Zdravotnické zařízení a Hlavní zkoušející budou provádět Studii a zajistí, že veškerý Personál studie, bude jednat a provádět Studii v souladu s touto Smlouvou, Protokolem (včetně jakýchkoli následných dodatků), Souborem informací pro zkoušejícího, veškerými písemnými Pokyny ke studii, Platnými právními předpisy, jmenovitě zákonem č. 378/2007 Sb. o léčivech ve znění pozdějších předpisů a vyhlášky č. 226/2008 Sb. o správné klinické praxi a bližších podmínkách klinického hodnocení léčivých přípravků ve znění pozdějších předpisů, a veškerými profesními normami platnými pro příslušné profesní odvětví ve znění platném v čase provádění Studie (např. Mezinárodní konference pro harmonizaci o správné klinické praxi) nebo kdykoli, kdy mohou být změněny nebo nahrazeny. Zdravotnické zařízení zajistí, aby Hlavní zkoušející plnil své povinnosti podle této ▇▇▇▇▇▇▇, a bude zodpovědné za jeho neplnění svých povinností a závazků podle této ▇▇▇▇▇▇▇.

Institution and Principal. Investigator understand that the information provided by Sponsor in connection with the Study may be considered to be material, nonpublic information that could affect the market price of the common stock of Sponsor.

Institution and Principal. Investigator represents, warrants and covenants that Personal Information related to Trial Subjects, when supplied to ▇▇▇▇▇▇▇, will be pseudonymized to replace any information that directly identifies a Trial Subject with a subject identification code. Principal Investigator will not provide ▇▇▇▇▇▇▇ with the key or code that enables Trial Subjects to be re-identified, under no circumstances ▇▇▇▇ ▇▇▇▇▇▇▇´s responsibility as Personal Data Controller transferred. Institution and Principal Investigator will notify ▇▇▇▇▇▇▇ immediately if Institution and/or Principal Investigator discovers that any Data (defined in Section 7.1) concerning Trial Subjects provided to ▇▇▇▇▇▇▇ does not satisfy this requirement. Principal Investigator will cooperate with all ▇▇▇▇▇▇▇ requests to mitigate any harm resulting from any such disclosure of Data. In such an event, Institution and Principal Investigator will deliver corrected Data to ▇▇▇▇▇▇▇ as promptly as possible at no extra expense to ▇▇▇▇▇▇▇.

Institution and Principal. Investigator shall comply and shall require any of the persons or entities performing the Services on their behalf to comply, with all Applicable Laws, rules, regulations, and guidelines governing the privacy of personally identifiable information and patient health information in Czech Republic.