Documentation and CRF Handling Sample Clauses

Documentation and CRF Handling. Dokumentácia a monitorovanie
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Documentation and CRF Handling. The Principal Investigator shall keep all original medical files (paper and print-outs of electronic files) of every subject participating in the Study in addition to the Case Report Forms (CRFs). This medical file will clearly identify each Study subject and where the medical files are the source documents, all entries on the CRFs must be traceable to entries in the medical file. The CRFs must reflect the current status of the Study for the respective subject and be completed and signed promptly by the Principal Investigator or their authorised delegate following a subject visit. The Principal Investigator warrants that all CRFs submitted to PAREXEL or the SPONSOR are true, complete and correct and accurately reflect the results of the Study. Principal Investigator undertakes, upon request, to provide PAREXEL and SPONSOR and their designees with direct access to all Study-related records, including patient medical files.

Related to Documentation and CRF Handling

  • Documentation and compliance (a) The data importer shall promptly and adequately deal with enquiries from the data exporter that relate to the processing under these Clauses. (b) The Parties shall be able to demonstrate compliance with these Clauses. In particular, the data importer shall keep appropriate documentation on the processing activities carried out on behalf of the data exporter. (c) The data importer shall make available to the data exporter all information necessary to demonstrate compliance with the obligations set out in these Clauses and at the data exporter’s request, allow for and contribute to audits of the processing activities covered by these Clauses, at reasonable intervals or if there are indications of non-compliance. In deciding on a review or audit, the data exporter may take into account relevant certifications held by the data importer.

  • Documentation and Record Keeping 1. Records to be Maintained Subrecipient shall maintain all records required by the Federal regulations specified in 24 CFR 570.506 that are pertinent to the activities to be funded under this Contract. Such records shall include, but not be limited to: a. Records providing a full description of each activity undertaken; b. Records demonstrating that each activity undertaken meets the one of the National Objectives of the CDBG program; c. Records required to determine the eligibility of activities; d. Records required to document the acquisition, improvement, use, or disposition of real property acquired or improved with CDBG assistance; e. Records documenting compliance with the fair housing and equal opportunity components of the CDBG program; f. Financial records as required by federal regulations 24 CFR 570.502, and 24 CFR 84.21-28; and g. Other records necessary to document compliance with Subpart K of 23 CFR.

  • Instrumentation The acceleration shall be recorded during the test, using equipment in accordance with channel frequency class 1000 as specified in the latest version of ISO 6487.

  • Medical Documentation The teacher must supply a letter from a medical 3 doctor, who treated the patient, stating that in his/her opinion, there is a strong 4 probability that the illness was contracted at school.

  • Implementation and Review The Parties shall consult annually, or as otherwise agreed, to review the implementation of this Chapter and consider other matters of mutual interest affecting trade in services. (10) 10 Such consultations will be addressed under Article 170 (Free Trade Commission) of Chapter 14 (Administration of the Agreement).

  • Approval of Documentation The form and substance of all certificates, instruments, opinions, and other documents delivered to Buyer under this Agreement shall be satisfactory in all reasonable respects to Buyer and its counsel.

  • EVALUATION AND MONITORING The ORGANIZATION agrees to maintain books, records and other documents and evidence, and to use accounting procedures and practices that sufficiently and properly support the complete performance of and the full compliance with this Agreement. The ORGANIZATION will retain these supporting books, records, documents and other materials for at least three (3) calendar years following the year in which the Agreement expires. The COUNTY and/or the State Auditor and any of their representatives shall have full and complete access to these books, records and other documents and evidence retained by the ORGANIZATION respecting all matters covered in and under this Agreement, and shall have the right to examine such during normal business hours as often as the COUNTY and/or the State Auditor may deem necessary. Such representatives shall be permitted to audit, examine and make excerpts or transcripts from such records, and to make audits of all contracts, invoices, materials, and records of matters covered by this Agreement. These access and examination rights shall last for three calendar years following the year in which the Agreement expires. The COUNTY intends without guarantee for its agents to use reasonable security procedures and protections to assure that related records and documents provided by the ORGANIZATION are not erroneously disclosed to third parties. The COUNTY will, however, disclose or make this material available to those authorized by/in the above paragraph or permitted under the provisions of Chapter 42.56 RCW without notice to the ORGANIZATION. The ORGANIZATION shall cooperate with and freely participate in any other monitoring or evaluation activities pertinent to this Agreement that the COUNTY finds needing to be conducted.

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Delivery of Documentation The Borrower undertakes: (a) to deliver; or (b) the delivery, to Mogo Auto by the Seller, of the documents set out in clause 10 of the Special Provisions of the Agreement and consents to their custody by Mogo Auto.

  • Documentation License Subject to the terms of this Agreement, Flock hereby grants to Agency a non- exclusive, non-transferable right and license to use the Documentation during the Term in connection with its use of the Services as contemplated herein, and under Section 2.5 below.

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