Action Taken Regarding the Investigational Drug Product. The Investigator will provide information regarding the action taken with respect to the IP in response to the AE.
Action Taken Regarding the Investigational Drug Product Sample Clauses
Related to Action Taken Regarding the Investigational Drug Product
Cooperation with Investigations You agree to cooperate with us in the investigation of unusual transactions, poor quality transmissions, and resolution of customer claims, including by providing, upon request and without further cost, any originals or copies of items deposited through the Service in your possession and your records relating to such items and transmissions.
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:
Investigational Services This plan covers certain experimental or investigational services as described in this section. Clinical Trials This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.
Formal Investigation Once the matter has been brought to the attention of the Store executive, an internal investigation of the complaint will be conducted at which time the complainant will be requested to present, in writing, the particulars of the harassment. Such internal investigation will be initiated no later than ten (10) business days of the matter being brought to the attention of the Store executive, and shall be concluded no later than thirty (30) business days of the initiation of the investigation. Any extension of the aforementioned time frames must have the agreement of the complainant and the union if the complainant has chosen to involve it. Based on the outcome of the investigation, which will be provided in writing upon the completion of the investigation, to both the complainant and the union, should the complainant consent to this disclosure, it will be determined if there has been a breach of Company policy on harassment, and the appropriate action will be taken in the event that harassment is determined to have occurred. STEP THREE - SUBSEQUENT INCIDENTS Subsequent incidents should immediately be reported and followed by a written description to the most senior store executive involved in Step Two for further investigation and disciplinary action, if confirmed, with a copy to the union Chairperson with the consent of the complainant. After all steps of the Harassment Protection Policy have been exhausted, if the incident has not been resolved to the satisfaction of the employee, the employee may file a grievance at Step 2 of the grievance procedure.
Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.
Authorization to Obtain Information You agree that we may obtain and review your credit report from a credit bureau or similar entity. You also agree that we may obtain information regarding your Payee Accounts in order to facilitate proper handling and crediting of your payments.
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.
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;
Independent Investigation Subscriber, in making the decision to purchase the Units, has relied upon an independent investigation of the Company and has not relied upon any information or representations made by any third parties or upon any oral or written representations or assurances from the Company, its officers, directors or employees or any other representatives or agents of the Company, other than as set forth in this Agreement. Subscriber is familiar with the business, operations and financial condition of the Company and has had an opportunity to ask questions of, and receive answers from the Company’s officers and directors concerning the Company and the terms and conditions of the offering of the Units and has had full access to such other information concerning the Company as Subscriber has requested. Subscriber confirms that all documents that it has requested have been made available and that Subscriber has been supplied with all of the additional information concerning this investment which Subscriber has requested.
Notification of Government Investigation or Legal Proceeding Within 30 days after discovery, Progenity shall notify OIG, in writing, of any ongoing investigation or legal proceeding known to Progenity conducted or brought by a governmental entity or its agents involving an allegation that Progenity has committed a crime or has engaged in fraudulent activities. This notification shall include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of such investigation or legal proceeding. Progenity shall also provide written notice to OIG within 30 days after the resolution of the matter, and shall provide OIG with a description of the findings and/or results of the investigation or proceeding, if any.
