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.
Thus, for example, RFC 1591 described relatively lightweight procedures for creating new top-level domains -- an issue that has more recently consumed years of debate without the creation of any new gTLDs. Since establishing the basic system of gTLDs and ccTLDs, Postel and IANA had created a small number of additional ccTLDs and a few limited-use gTLDs, but no gTLDs for general use.
Institution will also cooperate with Principal Investigator in ensuring that Study Records are maintained in a way that facilitates such activities.
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.
Principal Investigator and Institution will cooperate with regulatory authority and CRO or Pfizer representatives in the conduct of inspections and audits and will ensure that Study Records are maintained in a way that facilitates such activities.
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 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 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 shall include all documents, records and forms supplied to CRO by or on behalf of Company, or prepared, obtained or developed by CRO, in connection with the Services or CRO’s performance of this Agreement, including source documents, case report forms, laboratory data, and other similar documents.
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 all records required to be maintained under the Protocol, applicable laws of the Czech Republic and rules and regulations of any regulatory authority with jurisdiction over the Study. The Site shall promptly and fully produce all data, records and information relating to the Study to IQVIA and the Sponsor and their representatives during normal business hours, and shall assist them in promptly resolving any questions and in performing audits or reviews of original subject records, reports, or data sources. In the event that Study Records are either incomplete or out-of-date, IQVIA and/or Sponsor may retain trained health care professionals to assist in satisfactory completion of such documents. Site is obliged to retain the entire Study documentation, e.g. Protocol, CRFs, ISF, informed consent form, source data, documents facilitating identification of the Study subjects, in accordance with the applicable legal requirements, and in any event, for a period of twenty five (25) years after the end or the premature termination of the Study and after expiration of this retention period destroy the essential documents. Site will notify IQVIA and/or Sponsor immediately in writing of any accidental loss or destruction of Study records. The Site shall be responsible to prepare and maintain an accurate and complete database (“Database”) regarding the subjects enrolled in the Study according to the Protocol and mandatory law applicable to the Site. The Site may use the Database