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.
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.
Study Documentation shall not include Subjects' medical records and other original source documents.
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 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 IQVIA nebo obdržené od IQVIA 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 9.1.4 „Dokumentací ke studii“ se rozumí všechny záznamy, účty, poznámky, zprávy, údaje a komunikace s etickou komisí (podání, schválení a zprávy o pokroku), shromážděné, vytvořené nebo používané v souvislosti se studií a/nebo hodnoceným léčivým přípravkem, ať už v písemné, elektronické, optické nebo 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 evaluation and reconstruction of the Study. jiné formě, včetně všech zapsaných původních pozorování a poznámek ke klinickým aktivitám, jak jsou (e)CRF elektronické formuláře záznamu subjektu hodnocení nebo formuláře záznamu subjektu hodnocení a všechny další zprávy a záznamy potřebné pro vyhodnocení a rekonstrukci studie.
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 means all records, accounts, notes, reports, data and other documentation relating to the Study, whether in written, electronic, video or other tangible form, including all case report forms. “Case Report Form” means an accurate written report for each Subject in a format specified in the Protocol. “Source Documents” means all original documents, including but not limited to, observations and notations of clinical activities relating to the Study and all reports and records necessary for the evaluation and reconstruction of the Study, regardless of form.
Study Documentation all (i) Source Documents, (ii) Study Data and, (iii) to the extent not included in (i) or (ii), all records, accounts, notes and reports relating to the Study, whether in written, electronic, video or other tangible form, including: Ccase Rreport) required to be delivered to Sponsor pursuant to the Protocol and all records regarding inventories and dispositions of all Fforms; data correction forms; monitoring logs; appointment schedules; case histories; 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 Xxxxxxxxx, a všech záznamů týkajících se všech uložených formulářů a disponování s nimi, formulářů pro informed consent forms and related documentation; records of receipt, use, processing and disposition of the Investigational Product; approvals of (a) the applicable Protocol and any amendments thereto and (b) the informed consent forms by the Investigator, Site and the IRB/IEC; copies of all correspondence to or from Quintiles related to the Study, the Investigator, any other Study Staff, any IRB/IEC and any Governmental Official with respect to the Study; any other documentation required by the Protocol, this Agreement, or Applicable Law. While “Study Documentation” may include information derived from a Study Subject’s Medical Record, “Study Documentation” does not include any portion of the Medical Record. 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.