Training and Data Management Clause Samples

Training and Data Management. Measures specific to Investigator training and safety data management will be implemented as follows: • Investigator and site personnel training will include a focused review of expectations for monitoring safety and implementing risk mitigation. • Study data will be captured in real time using an EDC system, allowing for routine review of EDC data by the Sponsor’s Medical Monitor and clinical team, independent of the timing of on-site monitoring review. • Routine on-site review of study records and data by the Sponsor’s monitoring affiliate will begin directly after the first patient is treated at each study center. • A central clinical laboratory will be used for hematology, serum chemistry, and urinalysis to provide standardization across study centers, rapid on-line access to results, and customized alerts for results requiring exclusion/discontinuation, thereby allowing Investigators as well as the Sponsor’s Medical Monitor to identify potential safety issues early; standardized reference ranges for each test will be provided on every report of results and will also be available in the laboratory manual.‌‌‌‌ • A core cardiovascular laboratory will be used to provide standardization in ECG collection and interpretation across study centers, with rapid on-line access to results and customized alerts for exclusion/discontinuation. • SAE reports and associated data will be reviewed on an expedited basis by the Sponsor and its affiliates in order to meet reporting obligations and implement additional risk mitigation (if applicable).
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Related to Training and Data Management

  • Training a. The employer, in consultation with the local, shall be responsible for developing and implementing an ongoing harassment and sexual harassment awareness program for all employees. Where a program currently exists and meets the criteria listed in this agreement, such a program shall be deemed to satisfy the provisions of this article. This awareness program shall initially be for all employees and shall be scheduled at least once annually for all new employees to attend. b. The awareness program shall include but not be limited to: i. the definitions of harassment and sexual harassment as outlined in this Agreement; ii. understanding situations that are not harassment or sexual harassment, including the exercise of an employer's managerial and/or supervisory rights and responsibilities; iii. developing an awareness of behaviour that is illegal and/or inappropriate; iv. outlining strategies to prevent harassment and sexual harassment; v. a review of the resolution of harassment and sexual harassment as outlined in this Agreement; vi. understanding malicious complaints and the consequences of such; vii. outlining any Board policy for dealing with harassment and sexual harassment; viii. outlining laws dealing with harassment and sexual harassment which apply to employees in B.C.

  • PSN or Public Services Network The Public Services Network (PSN) is the government’s high performance network which helps public sector organisations work together, reduce duplication and share resources. Regulatory body or bodies Government departments and other bodies which, whether under statute, codes of practice or otherwise, are entitled to investigate or influence the matters dealt with in this Call-Off Contract. Relevant person Any employee, agent, servant, or representative of the Buyer, any other public body or person employed by or on behalf of the Buyer, or any other public body. Relevant Transfer A transfer of employment to which the employment regulations applies. Replacement Services Any services which are the same as or substantially similar to any of the Services and which the Buyer receives in substitution for any of the services after the expiry or Ending or partial Ending of the Call- Off Contract, whether those services are provided by the Buyer or a third party. Replacement supplier Any third-party service provider of replacement services appointed by the Buyer (or where the Buyer is providing replacement Services for its own account, the Buyer). Security management plan The Supplier's security management plan developed by the Supplier in accordance with clause 16.

  • Personnel Provide, without remuneration from or other cost to the Trust, the services of individuals competent to perform the administrative functions which are not performed by employees or other agents engaged by the Trust or by the Adviser acting in some other capacity pursuant to a separate agreement or arrangement with the Trust.

  • Subcontracts The contractor or subcontractor shall insert in any subcontracts the clauses set forth in paragraph (1.) through (4.) of this section and also a clause requiring the subcontractors to include these clauses in any lower tier subcontracts. The prime contractor shall be responsible for compliance by any subcontractor or lower tier subcontractor with the clauses set forth in paragraphs (1.) through (4.) of this section.

  • The Supplier must 12.1.1 comply with the Buyer’s written instructions and this Call-Off Contract when Processing Buyer Personal Data 12.1.2 only Process the Buyer Personal Data as necessary for the provision of the G-Cloud Services or as required by Law or any Regulatory Body 12.1.3 take reasonable steps to ensure that any Supplier Staff who have access to Buyer Personal Data act in compliance with Supplier's security processes