Recording of Data and Data Quality Assurance Sample Clauses

Recording of Data and Data Quality Assurance. Data will be documented in various source documents (eg, the patient medical chart) and then manually entered into the clinical trial database. Clinical sites will be monitored by ImmunoGen or its designee to ensure the accuracy of data against source documents. If necessary, the study site will be contacted for corrections or clarifications. Adverse events will be coded using the latest MedDRA version. Concomitant medications will be coded using the (WHO-DD; 01 September 2019 or later version. Training will occur at an Investigator meeting or at the site initiation visit or both. Remote web-based training may be provided. Instruction manuals (eg, laboratory manuals and pharmacy manuals) will be provided to aid consistency in data collection and reporting across sites. This clinical study will be conducted according to ICH-GCP E6 (R2) guidelines. Quality oversight shall be maintained through proactive and continual risk assessment and mitigation at the operational level. GCP quality assurance audits will be conducted as needed as continued compliance oversight.
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Related to Recording of Data and Data Quality Assurance

  • Introduction The Texas Health and Human Services Commission ("HHSC") and the Contractor named in Section I (HHSC and Contractor may be referenced in this document collectively as the “Parties” and individually as the “Party") hereby enter into this Community Services Contract - Provider Agreement (the “Contract”) for the provision of services under the Contract type specified in Section I for the considerations set forth herein. The Contract Begin Date specified in Section I is not valid until this Contract is signed by both parties.

  • Services FASC agrees to provide to the Adviser the services indicated in Exhibit A to this Agreement (the “Services”).

  • Dispute Resolution All or any disputes arising out or touching upon or in relation to the terms and conditions of this Agreement, including the interpretation and validity of the terms thereof and the respective rights and obligations of the Parties, shall be settled amicably by mutual discussion, failing which the same shall be settled through the adjudicating officer appointed under the Act.

  • GRIEVANCE PROCEDURE 7.01 For purposes of this Agreement, a grievance is defined as a difference arising between the parties relating to the interpretation, application, administration or alleged violation of the Agreement including any question as to whether a matter is arbitrable.

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  • Intellectual Property The Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the SEC Reports and which the failure to so have could have a Material Adverse Effect (collectively, the “Intellectual Property Rights”). None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or terminate or be abandoned, within two (2) years from the date of this Agreement. Neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the SEC Reports, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as could not have or reasonably be expected to not have a Material Adverse Effect. To the knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights. The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so could not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.

  • Background Purchaser wishes to purchase a Revenue Sharing Note issued by the Company through xxx.Xxxxxxxx.xxx (the “Site”).

  • General Provisions In connection with any Registration Statement and any Prospectus required by this Agreement to permit the sale or resale of Transfer Restricted Securities (including, without limitation, any Registration Statement and the related Prospectus required to permit resales of Initial Securities by Broker-Dealers), each of the Company and the Guarantors shall:

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