Authorization to Use and Disclose Health Information. Healthcare Provider will obtain through the Principal Investigator a written privacy authorization, complying with Applicable Law, for each Trial Subject which will enable Healthcare Provider to provide Sponsor and other persons and entities designated by Sponsor with completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those uses permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise klinického hodnocení do klinického hodnocení v souladu s protokolem. Předpokládaný počet zařazených subjektů hodnocení je xxxxx. 7.1. Multicentrické studie Klinické hodnocení je multicentrické a zadavatel může zastavit zařazování pacientů, bylo-li dosaženo celkového potřebného počtu subjektů klinického hodnocení. 8. Hlášení nežádoucích příhod Poskytovatel zdravotních služeb nahlásí nežádoucí příhody subjektů klinického hodnocení v souladu s pokyny protokolu a platnými předpisy. To v případě potřeby zahrnuje rychlé telefonické oznámení. Dojde-li u subjektu klinického hodnocení k újmě na zdraví v důsledku aplikace hodnoceného léčivého přípravku nebo náležitě provedených postupů klinického hodnocení, a jestliže se poskytovatel zdravotních služeb, hlavní zkoušející a další osoby účastnící se provádění klinického hodnocení řídili protokolem, veškerými platnými zákony a předpisy a veškerými směrnicemi zadavatele, uhradí zadavatel přiměřené náklady na léčebné výdaje nutné pro léčení této újmy. 9. Chráněné zdravotní informace Strany jsou si vědomy společného cíle zabezpečení všech individuálně identifikovatelných zdravotních informací, zachování jejich důvěrnosti a ochrany před neoprávněným zveřejněním. Poskytovatel zdravotních služeb prohlašuje a zaručuje, že bude dodržovat všechna ustanovení platných zákonů upravujících důvěrnost, ochranu soukromí a zabezpečení těchto informací. 9.1. Souhlas používat a sdělovat zdravotní informace Posky...
Authorization to Use and Disclose Health Information. Institution and Principal Investigator shall provide an appropriate privacy notice to each Trial Subject and obtain a written privacy authorization from each Trial Subject, complying with Applicable Law, which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. If such an authorization is separate from the ICF, Institution and Principal Investigator will only use the authorization that is approved by Sponsor, IEC and/or RA (if applicable). 10.1.
Authorization to Use and Disclose Health Information. Principal Investigator shall provide an appropriate privacy notice to each Trial Subject and obtain a written privacy authorization from each Trial Subject, complying with Applicable Law, which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Principal Investigator will only use the authorization that is provided by Sponsor. 10.1.
Authorization to Use and Disclose Health Information. Institution shall provide an appropiate privacy notice to each Trial Subject and obtain a written privacy authorization from each Trial Subject, complying with Applicable Law, which will enable Institution to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. If such an authorization is separate from the informed consent form (“ICF”), Institution will only use the authorization that is approved by Sponsor, IEC and/or RA (if applicable). 8.2.
Authorization to Use and Disclose Health Information. Institution and Principal Investigator will obtain a written privacy authorization, complying with Applicable Law, for each Trial Subject which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor, though not a covered entity, recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. If such an authorization is separate from the ICF, Institution and Principal Investigator will only use such authorization that is approved by Sponsor, IEC (if applicable) and regulatory authority (if applicable). 11.
Authorization to Use and Disclose Health Information. Institution shall provide an appropriate privacy notice to each Trial Subject and obtain written privacy authorization from each Trial Subject, complying with Applicable Law, which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. If such an authorization is separate from the ICF, Institution will only use the authorization that is approved by Sponsor, IEC and/or RA (if applicable). 8.1.
Authorization to Use and Disclose Health Information. Institution and Principal Investigator will obtain a written privacy authorization, complying with Czech Republic data protection laws and Applicable Law, for each Trial Subject which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor, though not a covered entity, recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. If such an authorization is separate from the ICF, Institution and Principal Investigator will only use such authorization that is approved by Sponsor, IEC (if applicable) and regulatory authority (if applicable).
Authorization to Use and Disclose Health Information. I hereby authorize and direct Audiology Experts to release confidential medical information to any entity, government agency, or insurance carrier in order to secure payment related to services rendered. Audiology Experts may also disclose my health information to the referring physician, family doctor, and school personnel for transfer of medical care, and follow-up purposes. In addition to the above, my protected health information may be shared with the following: (e.g. spouse, child): Patient Signature (Guardian if patient is a minor) Date
Authorization to Use and Disclose Health Information. Institution will obtain a written privacy authorization, complying with Applicable Law, for each Trial Subject which will enable Institution to provide Sponsor and other persons and entities designated by Sponsor with completed Case Report Forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor or 9.1
Authorization to Use and Disclose Health Information. Provider and Investigator will obtain a written privacy authorization, complying with all Applicable Law, from each Trial Subject, which will 10.1 Oprávnění použít a zveřejnit zdravotní informace. Poskytovatel a zkoušející v souladu se všemi platnými zákony získají od každého subjektu hodnocení písemný souhlas se zveřejněním osobních údajů, který enable Provider and Investigator to provide Sponsor and other persons and entities designated by Sponsor with completed electronic case report forms (“eCRFs”), source documents and all other data and documents and information required by the Protocol, for use by Sponsor for the purposes contemplated by this Agreement and the Protocol, including conducting and analyzing the results of the Trial and the Multi-Centre Study and obtaining and maintaining regulatory approvals for the Sponsor Drug. This written privacy authorization will also permit Sponsor to transfer such information outside the Czech Republic, including to the U.S. Each Party will comply with Applicable Law pertaining to data privacy to the extent such Applicable Law governs its responsibilities and activities under this Agreement. Sponsor, CRO, Provider and Investigator recognize that, pursuant to this Agreement, they have the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial and in accordance with Applicable Law. Neither Sponsor, CRO, Provider nor Investigator may use such information to recruit Trial Subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. Provider and Investigator will provide Sponsor or CRO an opportunity to review and approve the content of the authorization (including any revisions made during the course of the Trial) before it is used.
