Study Documentation includes all records related to the Study Device or Protocol, accounts, notes, reports and data, collected, generated or used in connection with the applicable Study, whether in written, electronic, video or other tangible form, including all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the Study. Study Documentation shall not include Subjects' medical records and other original source documents. The Principal Investigator and/or Institution will conduct data entry activities, which shall include entry of Subject data after Subject visit and response to queries, within the reasonable timelines provided by SPONSOR. For studies using web based electronic data capture technology (“EDC”), data will be entered in the EDC system at the Institution. Trained Study personnel will be responsible for entering data on the observations, tests and assessments specified in the Protocol into the EDC system and according to the CRF (as defined in Section 11.2). The CRF instructions will also provide the Institution with data entry instructions. Data entered in the EDC system will be automatically saved to a central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited, and Source Data Verification (“SDV”) performed, the Principal Investigator will be notified to sign the CRF electronically as per the agreed project process and data will be locked to prevent further editing. A copy of the CRF will be archived at the Institution at SPONSOR’s reasonable expense. When an electronic invalidated system that allows retrospective entry or correction of medical records data is issued, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facility at SPONSOR’s reasonable expense. The Principal Investigator’s electronic signature on such relevant medical record shall be the legally binding equivalent to a handwritten signature. If medical records of Subjects are held in a computerized medical record system, such system must be in full compliance with the applicable FDA rules on electronic records and signatures. In addition, and if applicable, Institution agrees to keep and maintain such records on the services provided as may be required by fiscal intermediaries, federal, state, or local governmental agencies, accreditation agencies, or other parties. Pursuant to Sect...
Study Documentation means all Regulatory Documentation pertaining to a Phase 3 Study and any Post-Approval Study in the Development Indication, including Source Documents, case report forms, data correction forms, case histories, monitoring reports and appointment schedules and any other documentation required by this Agreement or Applicable Law.
Study Documentation means all records, accounts, notes, reports and data, collected, generated or used in connection with the Study, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as case report forms and all other reports and records necessary for the evaluation and reconstruction of the Study.
Examples of Study Documentation in a sentence
The Study Documentation and any information disclosed to the Healthcare Service Provider by Vertex or by Vertex’s representatives (including a designated CRO as defined below) is considered as confidential information owned by Vertex (“Confidential Information”).
The Healthcare Service Provider will fully disclose to Vertex all work, reports, writings, designs, methods, computer software and data recorded in any form, including but not limited to the Study Documentation, that are created, developed, written, conceived or made by the Healthcare Service Provider, Study Staff or any other person involved in the Study as a result of or in connection with the Study or the performance of their obligations under this Agreement (collectively, “Study Work”).
For each Study, the Institution and the Principal Investigator shall prepare, maintain and retain complete, current, accurate, organized and legible Study Documentation (as defined below) in a manner acceptable for the collection of data for submission to, or review by, the FDA and other regulatory or governmental authorities as applicable, and in full compliance with the applicable Protocol and all Applicable Laws.
Study Documentation shall not include Subjects' medical records and other original source documents.
The Institution shall turn over all Study Documentation and materials in its possession associated with the Study, including all Work Product, Inventions and Materials, as expeditiously as possible, shall handle the Study Device in accordance with Section 9 and the instructions of SPONSOR and shall provide such other assistance as is necessary to ensure a smooth and orderly transition of the Study that will not involve any disruption of the Protocol.
More Definitions of Study Documentation
Study Documentation means any deliverables required to be collected or generated and reported to the Sponsor under the Protocol and/or Applicable Laws including, without limitation, all records, completed CRFs, accounts, notes, reports, analyses, documents, data and results collected or generated during the course of conducting the Study (including in written, electronic, video or other tangible form). While Study Documentation may include information derived from a Study Subject’s medical record or Sources Documents (as defined by the ICH), Study Documentation does not include any portion of such medical records or any Source Documents. Site shall maintain and store medical records and Study Documentation in a secure manner with physical and electronic access restrictions, as applicable and environmental controls appropriate to the applicable data type and in accordance with Section 13.2.1, Applicable Laws and industry standards.
Study Documentation means all records, accounts, notes, reports, data and ethics communications (submission, approval and progress reports), collected, generated or used in connection with the Study and/or Study Drug, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as (e)CRFs and all other reports and records necessary for the evaluation and reconstruction of the Study. "Dokumentace ke klinickému hodnocení" představuje všechny záznamy, účty, poznámky, hlášení, data a komunikaci s etickou komisí zdravotnického zařízení (IRB) (schvalovací dokumenty a hlášení o průběhu klinického hodnocení), které jsou shromažďovány, vytvářeny nebo používány v souvislosti s klinickým hodnocením a/nebo studijním léčivem. Patří sem, mimo jiné, všechny záznamy o klinických aktivitách, včetně záznamů subjektu hodnocení (CRFs) a ostatních záznamů a hlášení nezbytných pro vyhodnocení a opakovatelnost klinického hodnocení.
Study Documentation includes all records related to the Study Device or Protocol, accounts, notes, reports and data, collected, generated or used in connection with the applicable Study at the Institution, whether in written, electronic, video or other tangible form, including all recorded original observations and notations of clinical activities and all reports and records necessary for the evaluation and reconstruction of the Study as required by a Protocol and/or Applicable Laws. Study Documentation shall not include Subjects' medical records and other original source documents or the information contained therein. The Principal Investigator and/or Institution will conduct data entry activities, which shall include entry of Subject data after Subject visit and response to queries, within the reasonable timelines provided by SPONSOR in writing. For studies using web based electronic data capture technology (“EDC”), data will be entered in the EDC system at the Institution. Trained Study Personnel will be responsible for entering data on the observations, tests and assessments specified in the Protocol into the EDC system and according to the CRF (as defined in Section 11.2). The CRF instructions will also provide the Institution with data entry instructions. Data entered in the EDC system will be automatically saved to a central database and changes tracked to provide an audit trail. When data have been entered, reviewed, edited, and Source Data Verification (“SDV”) performed, the Principal Investigator will be notified to sign the CRF electronically as per the agreed project process and data will be locked to prevent further editing. A copy of the CRF will be archived at the Institution at SPONSOR’s reasonable expense. When an electronic medical record system that allows retrospective entry or correction of medical records data is used, Principal Investigator shall print, sign, date and file a copy of the relevant medical record each time a Subject visits a facility at SPONSOR’s reasonable expense. The Principal Investigator’s electronic signature on such relevant medical record shall be the legally binding equivalent to a handwritten signature. If medical records of Subjects are held in a computerized medical record system, such system must be in full compliance with the applicable FDA rules on electronic records and signatures. In addition, and if applicable, Institution agrees to keep and maintain such records on the services provided as may be required by, federal, st...
Study Documentation may include information derived from a Study Subject’s Medical Record, “Study Documentation” does not include any portion of the Medical Record. Studijní dokumentace: všechny (i) Zdrojové dokumenty, (ii) Studijní data a údaje, a (iii) v rozsahu, v jakém nejsou zahrnuty do položek (i) nebo (ii), také všechny záznamy, účty, poznámky a zprávy související se Studií, ať již v písemné či elektronické podobě, ve formě videa nebo jiné hmotné podobě, včetně záznamů subjektů hodnocení, které je nutno doručit Zadavateli podle Protokolu, a všech záznamů týkajících se všech uložených formulářů a disponování s nimi, formulářů pro opravu údajů, protokolů o monitorování, rozvrhů návštěv, historií případů, formulářů informovaného souhlasu a související dokumentace, záznamů o převzetí, použití, zpracování a nakládání s Hodnoceným léčivem, schválení (a) příslušného protokolu a jeho jakýchkoli dodatků, a (b) formulářů informovaného souhlasu Zkoušejícím, Místem provádění klinického hodnocení a EK, kopií veškeré korespondence zaslané společnosti Quintiles nebo obdržené od Quintiles týkající se Studie, Zkoušejícího, Studijního personálu, kterékoli EK a kteréhokoli Zástupce veřejné moci ve vztahu k Studii, a jakékoli další dokumentace požadované podle Protokolu, této Smlouvy nebo Příslušných právních předpisů. „Studijní dokumentace“ může obsahovat údaje odvozené ze Zdravotních záznamů Subjektu studie, ale neobsahuje žádnou část těchto Zdravotních záznamů.
Study Documentation means all records, accounts, notes, reports, data and ethics communications (submission, approval and progress reports), collected, generated or used in connection with the Study and/or Study Drug, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as (e)CRFs [Electronic Case Report Forms or Case Report Forms] and all other reports and records necessary for the 9 DUŠEVNÍ VLASTNICTVÍ 9.1 Pro účely této smlouvy: 9.
1.1 „Pověřenou osobou“ se rozumí xxxxx xxxxx písemně pověřená zadavatelem k provádění činností souvisejících se studií jménem zadavatele. Pověřenou osobou může být přidružená společnost nebo společnost Medpace.
9.1.2 „Vyvinutou technologií“ se rozumí veškeré vynálezy, objevy, zlepšení nebo výsledky vývoje učiněné poskytovatelem zdravotních služeb, hlavním zkoušejícím nebo pracovníky studie (ať už samostatně nebo ve spolupráci s ostatními) v průběhu studie nebo jako její výsledek, které přímo souvisí s hodnoceným léčivým přípravkem nebo jeho používáním.
Study Documentation means all documentation, data, information and materials supplied by Sponsor or Accelsiors to Institution and/or Investigator, including the Protocol and all electronic case report forms (e-CRFs), data, documentation, information, materials and results generated during the conduct of the Study. 2 Regulatory Authority (RA) Approval (ŠÚKL) 1.7 Dokumentácia ku klinickému skúšaniu bude znamenať akúkoľvek dokumentáciu, údaje, informácie a materiály dodané sponzorom alebo Accelsiorsom poskytovateľovi a/alebo skúšajúcemu zahrňujúc protokol a všetky elektornické kazuistiky (e-CRFs), údaje, dokumentáciu, informácie, materiály a výsledky generované v priebehu zavedenia klinického skúšania . 2 Schválenie ŠÚKLom
2.1 Accelsiors shall, on behalf and in the name of Sponsor, be responsible for securing any regulatory approvals (ŠÚKL), certificates, licenses or exemptions necessary to conduct the Study in compliance with the standards set forth by all applicable laws and regulations, Sponsor and this Agreement.
2.1 Accelsiors bude v zastúpení a v mene sponzora zodpovedný za zabezpečenie akýchkoľvek schválení ŠÚKLom, certifikátov, licencií alebo výnimiek potrebných k zavedeniu tohto klinického skúšania dodržaním všetkých platných zákonov a nariadení stanovených vopred sponzorom a touto zmluvou.
Study Documentation means all records, accounts, notes, reports, data and other documentation relating to the Study, whether in written, electronic, video or souladu s ustanoveními příslušných zákonů na ochranu osobních údajů, a pokud k této skutečnosti nedochází ve vztahu k uplatnění nároku či řízení iniciovaného subjektem hodnocení v souvislosti se studií. Smluvní strany tímto berou na vědomí a souhlasí s xxx, že jakékoliv anonymizované údaje shromážděné v souvislosti se studií budou převedeny mimo území Evropské unie. Je-li to zapotřebí, zavádějí se mezi smluvními stranami smlouvy o zpracování údajů pro přenos takových údajů a tyto smlouvy zahrnují ochranu údajů subjektů hodnocení, jak vyžaduje Evropská unie.