ICSR definition

ICSR means Individual Case Safety Report.

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ICSR means the document summarizing all available information related to an individual case safety report at a specific point of time. An Individual Case Safety Report (ICSR) is considered valid as soon as the four minimal elements are cumulatively available:

ICSR shall have the meaning set forth in Section 6.4(a). 1.126 “IFRS” shall have the meaning set forth in the definition of Accounting Standards. 1.127 “IND” means an Investigational New Drug application in the U.S. filed with the FDA or the corresponding application for the clinical investigation of pharmaceutical products in any other country or group of countries (including CTAs), as defined in the Applicable Laws and filed with the Regulatory Authority of such country or group of countries, and any amendments or supplements thereto. 1.128 “Indemnification Claim Notice” shall have the meaning set forth in Section 14.3(a). 1.129 “Indemnified Party” shall have the meaning set forth in Section 14.3(a). 1.130 “Indemnifying Party” shall have the meaning set forth in Section 14.3(a). 1.131 “Indirect Tax” shall have the meaning set forth in Section 9.8(b). 1.132 “Inflation Reduction Act” means 42 U.S.C. § 1320f et seq. 1.133 “Infringement Claim” shall have the meaning set forth in Section 10.5. 1.134 “Initial Technology Transfer” shall have the meaning set forth in Section 2.5(a). 1.135 “Initiate” or “Initiation” means, [**]. 1.136 “INN” shall have the meaning set forth in Section 8.3. 1.137 “Insolvency Event” shall have the meaning set forth in Section 12.2(d). 1.138 “Invention” means any invention, discovery or other Know-How that is discovered, generated, conceived or reduced to practice by or on behalf of a Party or its Affiliates

Examples of ICSR in a sentence

• Business Associate shall promptly remedy any violation of any provision of this ICSR exhibit.

• The fact that DHCS inspects, or fails to inspect, or has the right to inspect, Business Associate’s facilities, systems and procedures does not relieve Business Associate of its responsibility to comply with this ICSR exhibit.

• From time to time, DHCS may inspect the facilities, systems, books and records of the Business Associate to monitor compliance with the safeguards required in the Information Confidentiality and Security Requirements (ICSR) exhibit.

• From time to time, DHCS may inspect the facilities, systems, books and records of the Contractor to monitor compliance with the safeguards required in the Information Confidentiality and Security Requirements (ICSR) exhibit.

• Contractor shall promptly remedy any violation of any provision of this ICSR exhibit.

• The fact that DHCS inspects, or fails to inspect, or has the right to inspect, Contractor’s facilities, systems and procedures does not relieve Contractor of its responsibility to comply with this ICSR exhibit.

• Where a CMS ICSR is added to the Global Safety Database, NORGINE will provide the Global Safety Database unique case identifier.

• If a request is received from the Regulatory Authorities related to specific ICSRs, the Party in whose Territory the ICSR was reported will be responsible for obtaining the requested information from the Affiliate, reporter or Investigator, as appropriate.

• Any Adverse Event or Serious Adverse Event, as defined in 21 CFR 314 or designated as post-authorization ICSR by Volume 9A of the “Rules Governing Medicinal Products in the European Union: Pharmacovigilance for medicinal products for human use”, as appropriate, will be reported to Supplier as soon as possible after receipt of the incident by Company or its designated contract call center so that regulatory reporting requirements can be met.

• RECONCILIATION OF ICSR EXCHANGE BETWEEN THE PARTIES On a quarterly basis, by day TEN (10) NORGINE will send to CMS an AE reconciliation report to enable CMS to perform reconciliation of ICSRs received by NORGINE directly from CMS.

More Definitions of ICSR

ICSR shall have the meaning set forth in Section 6.4(b) (Transfer of Legacy Safety Data).

ICSR means a report providing the most complete information related to an individual adverse event case at a certain point of time.

ICSR means a report that contains information describing a suspected AE, ADR, SAE or SUSAR related to the administration of one or more medicinal products to an individual patient and, subject to any amendment pursuant to the ICH from time to time, contains the minimum information required for expedited reporting, including: an identifiable patient, a suspected medicinal product, an identifiable reporter, and an AE, ADR, SAE or SUSAR.

ICSR means a document that presents the most complete, relevant information provided by a reporter to describe an individual subject’s adverse event(s)/adverse reaction(s) related to the administration of one or more (investigational) medicinal products at a particular point in time.

ICSR means individual case safety reports relating to the following events associated with the use of or exposure to Product. Adverse Events (AEs), including AEs associated with any product complaints; Suspected Transmission of an Infectious Agent via the Product; Pregnancy Exposures; Lactation Exposures; Special Situations (regardless of whether there is an associated AE); Invalid Cases (at least an adverse event and a suspected product are available). CMS agrees to provide Neurelis, or it’s designee, with all relevant safety information in relation to Study, including both initial and follow-up reports, in accordance with timelines and formats set forth in Table 1. To the extent possible, the ICSR must include at a minimum: An identifiable patient/subject; An identifiable reporter; A suspect medicinal product; One or more AEs or Special Situations. In addition to safety data, each ICSR exchanged under this PVA will contain the following information: The reporting Party’s Awareness Date; Identification of whether the report is an initial or follow up report; A unique company case identification number (ID) assigned by the reporting Party; and A description of the source of the report (i.e., clinical study). Every effort should be made by CMS to obtain the minimal requirements for an ICSR. However, if this is not possible, CMS should send whatever information is available to Neurelis, or it’s designee, as indicated in Appendix 2 – Contact Details, within the timeframe indicated in Table 1. With respect to the ICSRs, CMS will be responsible to conduct follow up as may be required by either applicable laws or that Party’s SOPs. CMS will be responsible for causality assessment with respect to an AE, but either Party may, in its discretion, include a statement of its own causality assessment, or change seriousness of events based on its own medical judgement when submitting the ICSR to governmental authority to whom that Party has regulatory reporting requirements. In exceptional cases and where additional information is considered essential in order to fully assess a case, Neurelis, or it’s designee, may request CMS to contact the reporter and obtain additional information. If the reporter has no response or is unwilling to provide additional tracking information, the requested time can be extended or the case can be closed. CMS should inform Neurelis, or it’s designee, of the outcome with the same company case ID as the original report and shall be exchanged in t...