Relationship to Investigational Product Sample Clauses

Relationship to Investigational Product. The investigator must make the determination of relationship to the IP for each adverse event (not related, related). The following definitions should be considered when evaluating the relationship of AEs and SAEs to the IP. An AE will be considered “not related” to the use of the IP if there is not a reasonable possibility that the event has been caused by the IP. Factors pointing towards this assessment include but are not limited to: the lack of temporal relationship between administration of the IP and the event, the presence of biologically implausible relationship between the product and the AE, or the presence of a more likely alternative explanation for the AE Not Related An AE will be considered “related” to the use of the IP if there is a reasonable possibility that the event may have been caused by the product under investigation. Factors that point towards this assessment include but are not limited to: a positive rechallenge, a reasonable temporal sequence between administration of the drug and the event, a known response pattern of the suspected drug, improvement following discontinuation or dose reduction, a biologically plausible relationship between the drug and the AE, or a lack of alternative explanation for the AE Related
Sample 1
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Relationship to Investigational Product. For each AE, the Investigator determines whether there is a reasonable likelihood that the AE may have been caused by the study treatment according to the categories below: Unrelated: The event is clearly not related to the IP Possibly/probably related: The event could be related/is likely to be related to the IP Definitely related: The event is clearly related to the IP AEs that the Investigator or Sponsor considers to be possibly, probably, or definitely related to the IP will be considered adverse drug reactions.
Sample 1
Relationship to Investigational Product. The Investigator will document her/his opinion of the relationship of the AE to treatment with the investigational product using the criteria outlined in Table 8. An AE for which there is a “reasonable possibility” that the investigational product caused the AE means there is evidence to suggest a causal relationship between the investigational product and the AE. If the relationship between the AE/SAE and the investigational product is determined to be “possible” or “probable,” the event will be considered related to the investigational product. Table 8: Relationship of Adverse Events to Investigational Product Relationship Description Related • A clinical event, including laboratory test abnormality, with a reasonable time sequence to administration of the investigational product, unlikely to be attributed to concurrent disease or other drugs or chemicals, and which follows a clinically reasonable response on withdrawal (de-challenge); or • An event that could also be explained by concurrent disease or other drugs or chemicals where information on investigational product withdrawal may be lacking or unclear. • Re-challenge or de-challenge information is not required to fulfill this definition. Not Related • A clinical event, including laboratory test abnormality, with sufficient evidence to accept that there is no causal relationship to investigational product administration (eg, no temporal relationship to investigational product administration, because the investigational product was administered after onset of event; investigation shows that the drug was not administered; proof of other cause; etc.); or • An event with a temporal relationship to investigational product administration, which makes a causal relationship improbable, and other drugs, chemicals or underlying disease provide plausible explanations.
Sample 1

Related to Relationship to Investigational Product

  • BACKGROUND INVESTIGATION The BOARD is prohibited from knowingly employing a person who has been convicted of committing or attempting to commit certain criminal offenses. If the required criminal background investigation is not completed at the time this Contract is signed, and the subsequent investigation report reveals that there has been a prohibited conviction, this Contract shall immediately become null and void.

  • Background and/or Criminal History Investigation Prior to commencement of any services, background and/or criminal history investigation of the Vendor’s employees and subcontractors who will be providing services to the Customer under the Contract may be performed by the Customer. Should any employee or subcontractor of the Vendor who will be providing services to the Customer under the Contract not be acceptable to the Customer as a result of the background and/or criminal history check, then Customer may immediately terminate its Purchase Order and related Service Agreement or request replacement of the employee or subcontractor in question.

  • Complaints Investigation ‌ An employee who complains of harassment under the provisions of the Human Rights Code of British Columbia may refer the complaint to either one or other of the following processes:

  • Background Investigations OSC policy requires that background investigations be conducted on Contractor Staff who will have access to OSC’s IT systems, access to OSC confidential information/data, or routine access to any OSC facility. For purposes of this policy, “routine access” is defined as access to an OSC facility for five consecutive business days or 10 business days over the annual term of the engagement. Accordingly, with the signing of this Agreement, the Contractor certifies that it has or will conduct a background investigation on Staff to whom the policy applies within the 12 months prior to the Staff commencing Services under this Agreement. The Contractor agrees to undertake a background investigation of any new/replacement Staff during the term of the Agreement. At a minimum, background investigations shall include a review/evaluation of the following: • identity verification, including Social Security Number search; • employment eligibility, including verification of U.S. citizenship or legal immigration status where appropriate; • criminal history/court records (Federal, State and local for the past five years); • work experience/history for the past five years; • pertinent skills, qualifications, and education/professional credentials; and • references. The Contractor must obtain the consent of its Staff to allow OSC, upon request: (i) to review the background investigation records, including all supporting documentation, and (ii) to conduct its own background investigation. Only Staff who have passed the background investigation, and provided such consent shall be assigned to provide Services to OSC under this Agreement. During the term of the Agreement, and in accordance with Appendix A (Section 10, Records), the Contractor must maintain records related to the background investigations performed.

  • Prohibition Against Selecting and Installing Products Containing Hazardous Materials The Contractor shall not select, install or otherwise incorporate any products or materials containing Hazardous Materials within the boundaries of the Site. Should the Contractor or any Subcontractors have knowledge that, or believe that, an item, component, material, substance, or accessory within a product or assembly selected by the Contractor or any Subcontractor may contain Hazardous Materials it is the Contractor’s responsibility to secure a written certification from the manufacturer of any suspected material which identifies the specific Hazardous Material(s) contained, together with the Material Safety Data Sheets (MSDS) for such materials which shall be submitted to the Owner and Design Professional.

  • Patent Filing Responsibilities and Costs 1. The invention and patent rights herein apply to any patent application or patents covering an invention made under this Agreement. Each Party is responsible for its own costs of obtaining and maintaining patents covering sole inventions of its employees. The Parties may agree otherwise, upon the reporting of any invention (sole or joint) or in any license granted.

  • TECHNOLOGY/KNOWLEDGE TRANSFER ACTIVITIES The goal of this task is to develop a plan to make the knowledge gained, experimental results, and lessons learned available to the public and key decision makers. The Recipient shall: • Prepare an Initial Fact Sheet at start of the project that describes the project. Use the format provided by the CAM. • Prepare a Final Project Fact Sheet at the project’s conclusion that discusses results. Use the format provided by the CAM. • Prepare a Technology/Knowledge Transfer Plan that includes: o An explanation of how the knowledge gained from the project will be made available to the public, including the targeted market sector and potential outreach to end users, utilities, regulatory agencies, and others.

  • Investigation of Grievances The investigation of grievances shall not interfere with the orderly process of education in District 281.

  • Criminal Background Investigations For investigative Vendor Staff, Citizens will accept a copy of a current Class C Private Investigator license as proof that a criminal background check has been conducted for that investigator. For all other Vendor Staff, Vendor must provide Citizens with a copy of a criminal background check performed on such Vendor Staff dated within thirty (30) days of submission of the Vendor Staff to Citizens for qualification and credentialing review. Vendor shall use Exhibit D, Applicant Background Review Guide to as a guideline to determine eligibility of Vendor Staff to perform Services. The criminal background check must be updated every two (2) years thereafter. All background checks will be at Vendor’s expense and, unless otherwise approved in writing by Citizens’ Contract Manager, shall include but not be limited to: (a) state and federal felony convictions or pending adjudications; (b) state and federal misdemeanor convictions or pending adjudications; (c) any crimes in violation of the Violent Crime Control and Law Enforcement Act of 1995 or pending adjudications; and, (d) a seven (7) year minimum timeframe, extending as close as practicable to the date of Assignment to perform Services. Vendor will advise Citizens’ Contract Manager or designee if it knows of any Vendor Staff that has a criminal conviction (misdemeanor or felony), regardless of adjudication (adjudication withheld, a plea of guilty or nolo contendere, or a guilty verdict), within the last ten (10) years in any jurisdiction. Vendor shall not allow that individual to act as a Vendor Staff until Vendor determines whether that individual should be allowed to do so considering (a) the nature and gravity of the offense; (b) the amount of time that lapsed since the offense;

  • Xxxxxx and Recall An employee in receipt of notice of layoff pursuant to 9.08(A)(a)(ii) may:

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