Study Records definition
Study Records means, collectively, all documentation and other records (whether in written or electronic format) related to the conduct of the Study, including, without limitation, documentation and records concerning: (i) the Site; (ii) the solicitation, screening, evaluation, enrollment and testing of subjects (including the relevant portions of other pertinent records concerning such subjects); (iii) the procedures, tests and other activities performed during the Study; and (iv) all financial records related to the conduct of the Study.
Study Records means in relation to contracted activities, all records, notes, reports (including case report forms; monitoring logs; data correction forms; case histories; medical images; drug safety records; records of receipt, use, processing and disposition of Test Materials and trial master file) and other observations, notations or data of activities or procedures (in each case whether in a written or electronic format) which Covance obtains from each Investigator or which Covance specifically generates or produces for the relevant Study under the Regulatory Requirements, excluding the Study subject’s personal medical records.
Study Records refers to all information regardless of purpose, format, location, system or origination that is a result of the conduct of a Study and/or performance of Services by INC Research and/or any INC Research sub-contracted service providers.
Examples of Study Records in a sentence
CRO or Pfizer may also audit Study Records during or after the Study as part of its monitoring of Study conduct.
For Confidential Information other than Personal Data (as defined in Section 6, Data Protection and FDA Financial Disclosure), Study Data, and Biological Sample Analysis Data (as defined in Section 11, Study Data, Biological Samples, and Study Records), these obligations of nonuse and nondisclosure survive termination of this Agreement and continue for a period of five years after termination.
Principal Investigator and Institution acknowledge that the Study is subject to inspection by regulatory authorities worldwide, including the United States FDA, and that such inspections may occur after completion of the Study and may include auditing of Study Records.
Institution will also cooperate with Principal Investigator in ensuring that Study Records are maintained in a way that facilitates such activities.
Obligations relating to Funding, Confidential Information, Study Records, Inventions, Publications, Sponsor Insurance Coverage, Suitability, and Anti-Corruption survive termination of this Agreement, as does any other provision in this Agreement, including Attachments, that by its nature and intent remains valid after the term of the Agreement.
More Definitions of Study Records
Study Records means, collectively, all documentation and other records (whether in written or electronic format) related to the conduct of the Study, including, without limitation, documentation and records concerning: (a) Pojem „záznamy z klinického hodnocení“ bude souhrnně znamenat veškerou dokumentaci a jiné záznamy (ať už v písemné či elektronické podobě), které souvisejí s prováděním klinického hodnocení, mimo jiné včetně dokumentace a záznamů, které se týkají:
(i) the Site; (i) centra;
(ii) the solicitation, screening, evaluation, enrollment and testing of subjects (including the relevant portions of other pertinent records concerning such subjects); (ii) náboru, screeningu, hodnocení, zařazování a testování pacientů (včetně relevantních částí jiných příslušných záznamů týkajících se těchto pacientů);
(iii) the procedures, tests and other activities performed during the Study; and (iii) postupů, vyšetření a jiných úkonů prováděných během klinického hodnocení; a
(iv) all financial records related to the conduct of the Study.
Study Records means records and documents pertaining to the conduct of the
Study Records means the Services Record and Study Related Data relating to a GSK Research Program that have to be retained as required by Applicable Law or upon GSK’s written request.
Study Records means all records required under 21 C.F.R. §§312.57, 312.62 and 312.64 or any other Applicable Law relating to disposition of the Investigational New Drug and treatment of Subjects, including, without limitation, all CRFs, all other reports submitted by Sites to BIND pursuant to the Study, and all other related data and results obtained or generated by Sites or Study Personnel in the course of the Study, subject to the exclusions set forth in Section 7.2.
Study Records in relation to Services, means all records, notes, reports and other observations, notations or data of activities or procedures (in each case whether in a written or electronic format) which Labcorp specifically generates or produces for the relevant Study under Applicable Law, excluding the Study participant’s personal medical records.
Study Records means, collectively, all documentation and other records (whether in written or electronic format) related to the conduct of the Study, including, without limitation, documentation and records concerning: 106B(a) Pojem „záznamy z klinického hodnocení“ bude souhrnně znamenat veškerou dokumentaci a jiné záznamy (ať už v písemné či elektronické podobě), které souvisejí s prováděním klinického hodnocení, mimo jiné včetně dokumentace a záznamů, které se týkají: 258B(i) the Site; 259B(i) centra; 260B(ii) the solicitation, screening, evaluation, enrollment and testing of subjects (including the relevant portions of other pertinent records concerning such subjects); 261B(ii) náboru, screeningu, hodnocení, zařazování a testování pacientů (včetně relevantních částí jiných příslušných záznamů týkajících se těchto pacientů); 262B(iii) the procedures, tests and other activities performed during the Study; and 263B(iii) postupů, vyšetření a jiných úkonů prováděných během klinického hodnocení; a 264B(iv) all financial records related to the conduct of the Study. 265B(iv) všech finančních záznamů souvisejících s prováděním klinického hodnocení. 107B(b) All Study Records must be retained for the longer of: 108B(b) Všechny záznamy z klinického hodnocení musí být uchovávány po delší z následujících období: 266B(i) two (2) years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region for the Sponsor´s Study Drug(s) for the indication being investigated; or 267B(i) dva (2) roky po posledním schválení žádosti o uvedení přípravku na trh v oblasti podle ICH, a dokud nebudou v oblasti podle ICH podány pro hodnocený(é) přípravek(y) Zadavatele ve zkoumané indikaci žádosti o registraci čekající na vyřízení, ani nebude jejich podání zamýšleno; nebo 268B(ii) two (2) years after the relevant regulatory authorities are notified by Sponsor or CRO of discontinuation of the development of any of the Sponsor´s Study Drug(s). 269B(ii) dva (2) roky po oznámení zadavatele nebo CRO příslušným regulačním orgánům, že klinický vývoj kteréhokoli hodnoceného(ých) přípravku(ů) Zadavatele byl ukončen. In no event, including without limitation expiration of the retention periods above, shall V žádném případě, mimo jiné včetně vypršení výše zmíněných lhůt pro uchovávání, nezničí either Institution or Investigator destroy any Study Records without the prior written consent of Sponsor. zdravotnické zařízení a...
Study Records means Assay Related Data, Non Assay Related Data reference materials, as well as any and all information pertaining to the Services carried out under this Master Agreement and any Task Order(s) that has to be retained as required by Applicable Laws or guidelines or upon GSK’s written request.