CIOMS I definition

CIOMS I means Council for International Organizations of Medical Sciences common adverse experience reporting form.
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CIOMS I means a standardized international reporting form for individual case safety reports.
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Examples of CIOMS I in a sentence

  • Such notice shall be provided in English in the form of a processed CIOMS I within [***] days of such Party receiving such information where such potential Adverse Events is a SAE and associated with the clinical uses, Clinical Studies, investigations, tests or marketing of such Collaboration Product for such Program.

  • After the Closing, Seller shall promptly provide Purchaser an electronic copy of the CIOMS I form for all legacy data of Adverse Events with respect to any Seller Product that is within Seller’s (or its Affiliate’s, as appropriate) possession, for inclusion in Purchaser’s safety database for the Product.

  • All reports will be forwarded using the CIOMS I Format, and per the timelines identified in this section 16.

  • Information to be Exchanged CMS is responsible for the collection of all safety information from the Territory and will notify NORGINE of all information it receives as specified in this section 16, concerning Product using the CIOMS I format.

  • While exposure via pregnancy itself is not a serious adverse event, Aptalis and Strakan will exchange all reports of exposure via pregnancy by Calendar Day 7 from Receipt Date preferably using on FDA 3500 A MedWatch form or Council for International Organizations of Medical Sciences’ (CIOMS) I form via designated e-mail.

  • The transmission shall be preferably made by email directly to the Global Drug Safety and Risk Management as in Appendix E, using the CIOMS I format for medicinal products.

  • ICSRs with all available information shall be submitted by NORGINE to the CMS using CIOMS I format and xml (ICH E2B) format no later than TWELVE (12) Calendar Days after receipt Day Zero.

  • At the time of the expected due date CMS shall seek follow up from the reporting source on the outcome of pregnancy and complete CIOMS I format as per the timelines identified in this section 16.

  • All reports will be forwarded using the CIOMS I format, and per the timelines identified in this section 16.

  • The transmission will normally be by email, using the CIOMS I format for medicinal products as well as in xml file.

Related to CIOMS I

  • NI 81-107 means National Instrument 81-107 Independent Review Committee for Investment Funds;

  • IMRO means the Irish Music Rights Organisation CLG.

  • Primer means a coating labeled and formulated for application to a substrate to provide a firm bond between the substrate and subsequent coats.

  • NI 52-107 means National Instrument 52-107 Acceptable Accounting Principles, Auditing Standards and Reporting Currency;

  • NI 45-106 means National Instrument 45-106 Prospectus Exemptions;