Source Data Recorded on the Case Sample Clauses

Source Data Recorded on the Case. Report Form Data will be collected by using an eCRF in compliance with Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) Part 11. As required by Good Clinical Practice (GCP), the sponsor-assigned or sponsor designee-assigned monitor will verify, by direct reference to the source documents, that the data required by the protocol are accurately reported on the eCRF. The source documents must, at a minimum, contain a statement that the subject is included in a clinical study, the date that informed consent was obtained prior to participation in the study, the identity of the study, diagnosis and eligibility criteria, visit dates (with subject status), IMP administration, and any AEs and associated concomitant medication. As required by International Conference on Harmonisation (ICH) GCP Section 6.4.9, if some items are recorded directly on the eCRF and are considered as source data, the identification of these data must be documented and agreed between the investigator and the sponsor. Definition for source data and source documents are given below:
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Related to Source Data Recorded on the Case

  • DOCUMENTATION; RECORDS OF PROCESSING Each party is responsible for its compliance with its documentation requirements, in particular maintaining records of processing where required under Data Protection Law. Each party shall reasonably assist the other party in its documentation requirements, including providing the information the other party needs from it in a manner reasonably requested by the other party (such as using an electronic system), in order to enable the other party to comply with any obligations relating to maintaining records of processing.

  • Exception Where Databases Contain Sufficient Information A Reporting Financial Institution is not required to perform the paper record search described in subparagraph D.2. of this section if the Reporting Financial Institution’s electronically searchable information includes the following:

  • List of Operator’s Subprocessors [Box 26] [Box 27] [Box 28] [Box 29]

  • MARC Records When applicable to the Licensed Materials, at Licensee’s request, Licensor shall provide full OCLC-quality batched sets of MARC records incorporating Licensee specifications at no additional cost by the date of the execution of this License Agreement. Updates to existing records and new title records, matching the schedule of release and delivery of new publications, will be provided on a mutually agreed-upon schedule and in a format that renders them useful to the Licensee and/or the Participating Institutions.

  • Medical Records Medical records relating to Trial Subjects that are not submitted to Sponsor may include some of the same information as is included in Trial Data; however, Sponsor makes no claim of ownership to those documents or the information they contain. c.

  • Public Records Request (09/17) Contractor acknowledges that the City of Portland is subject to the Oregon Public Records Act and Federal law. Third persons may claim that the Confidential Information Contractor submitted to the City hereunder may be, by virtue of its possession by the City, a public record and subject to disclosure pursuant to the Oregon Public Records Act. The City’s commitments to maintain certain information confidential under this Contract are all subject to the constraints of Oregon and federal laws. All information submitted by Contractor is public record and subject to disclosure pursuant to the Oregon Public Records Act, except such portions for which Contractor requests and meets an exemption from disclosure consistent with federal or Oregon law. Within the limits and discretion allowed by those laws, the City will maintain the confidentiality of information.

  • FALSE STATEMENTS CONCERNING HIGHWAY PROJECTS T h i s p r o v i s i o n i s applicable to all Federal-aid construction contracts and to all related subcontracts. In order to assure high quality and durable construction in conformity with approved plans and specifications and a high degree of reliability on statements and representations made by engineers, contractors, suppliers, and workers on Federal- aid highway projects, it is essential that all persons concerned with the project perform their functions as carefully, thoroughly, and honestly as possible. Willful falsification, distortion, or misrepresentation with respect to any facts related to the project is a violation of Federal law. To prevent any misunderstanding regarding the seriousness of these and similar acts, Form FHWA-1022 shall be posted on each Federal-aid highway project (23 CFR 635) in one or more places where it is readily available to all persons concerned with the project: 18 U.S.C. 1020 reads as follows: "Whoever, being an officer, agent, or employee of the United States, or of any State or Territory, or whoever, whether a person, association, firm, or corporation, knowingly makes any false statement, false representation, or false report as to the character, quality, quantity, or cost of the material used or to be used, or the quantity or quality of the work performed or to be performed, or the cost thereof in connection with the submission of plans, maps, specifications, contracts, or costs of construction on any highway or related project submitted for approval to the Secretary of Transportation; or Whoever knowingly makes any false statement, false representation, false report or false claim with respect to the character, quality, quantity, or cost of any work performed or to be performed, or materials furnished or to be furnished, in connection with the construction of any highway or related project approved by the Secretary of Transportation; or Whoever knowingly makes any false statement or false representation as to material fact in any statement, certificate, or report submitted pursuant to provisions of the Federal-aid Roads Act approved July 1, 1916, (39 Stat. 355), as amended and supplemented; Shall be fined under this title or imprisoned not more than 5 years or both."

  • Data Storage Where required by applicable law, Student Data shall be stored within the United States. Upon request of the LEA, Provider will provide a list of the locations where Student Data is stored.

  • Medical Records Retention Grantee will;

  • FORMAT AND CONTENT FOR REGISTRY OPERATOR MONTHLY REPORTING Registry Operator shall provide one set of monthly reports per gTLD, using the API described in draft-­‐xxxxxx-­‐icann-­‐registry-­‐interfaces, see Specification 2, Part A, Section 9, reference 5, with the following content. ICANN may request in the future that the reports be delivered by other means and using other formats. ICANN will use reasonable commercial efforts to preserve the confidentiality of the information reported until three (3) months after the end of the month to which the reports relate. Unless set forth in this Specification 3, any reference to a specific time refers to Coordinated Universal Time (UTC). Monthly reports shall consist of data that reflects the state of the registry at the end of the month (UTC).

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