CIOMS definition

Examples of CIOMS in a sentence

  • Geneva 1992.4. International reporting of Adverse Drug Reactions: Final report of the CIOMS working group.

  • Council for International Organizations of Medical Sciences (CIOMS).

  • Guidelines for Preparing Core Clinical-Safety Information on Drugs Second Edition – Report of CIOMS Working Groups III and V.

  • A CIOMS format “initial” report which follows a previous (first) communication from the applicant must be clearly marked that it is a follow up and linked through the applicant-assigned reference number.

  • Belmont Report.2. Council for International Organisations of Medical Sciences (CIOMS).

  • The sponsor may submit foreign suspected adverse reactions on a Council for International Organizations of Medical Sciences (CIOMS) I Form instead of a FDA Form 3500A.

  • International research must also comply with 45 CFR 46 or equivalent standards, such as the 1993 Council of International Organization of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects and the International Conference on Harmonization (ICH) standards.The IRB must consider the following in addition to the review requirements described in Section VI, “IRB Review of Research” and in other relevant sections of this document.

  • The Council for International Organizations of Medical Sciences (CIOMS) in collaboration with WHO (CIOMS 2016) has also developed ethical guidelines for health-related research on consent (including consent for unspecified future use) for the collection, storage and use of biological material and related data.

  • Safety information on serious adverse events shall be provided in CIOMS format and safety information on non-serious adverse events shall be provided in English Line Listing format.

  • The guidelines were partly derived from the International Conference on Harmonization Good Clinical Practice (ICH GCP) and from the International Ethical Guidelines for Biomedical Research involving human subjects prepared by the Council for International Organizations of Medical Sciences (CIOMS) in collaboration with World Health Organization (WHO 2002).

Related to CIOMS

  • Dataset means the data specified in Appendix 1 (Environmental Information) to Schedule 11.2 (Management Information) as the same may be amended from time to time by the Secretary of State (acting reasonably);

  • ODMHSAS means the Oklahoma Department of Mental Health and Substance Abuse Services.

  • Sample means urine, blood, breath, saliva, or hair.

  • QA means Quality Assurance.

  • HCD means the California Department of Housing and Community Development.

  • Forensic analysis means the practice of gathering, retaining, and analyzing computer-related data for investigative purposes in a manner that maintains the integrity of the data.

  • API means the American Petroleum Institute.

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.

  • SMS means short message service provided by your mobile service provider which:

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Tomogram means the depiction of the x-ray attenuation properties of a section through the body.

  • Batch Record means the production record pertaining to a Batch.

  • Stability (7) means the standard deviation (1 sigma) of the variation of a particular parameter from its calibrated value measured under stable temperature conditions. This can be expressed as a function of time.

  • CRF means the case report form in a format prepared by Sponsor and documenting the administration of the Investigational Product to Clinical Trial Subjects as well as all tests and observations related to the Clinical Trial;

  • CMS means the Centers for Medicare and Medicaid Services.

  • risk analysis the analysis required under Rule 17f-7(a)(1)(i)(A).

  • Mail order pharmacy means a pharmacy licensed by this

  • MCIP means (i) the joint county industrial park established pursuant to the terms of the MCIP Agreement and (ii) any joint county industrial park created pursuant to a successor park agreement delivered by the County and a partner county in accordance with Section 4-1-170 of the MCIP Act, or any successor provision, with respect to the Project.

  • System Data means data and data elements collected by the SaaS Software, SaaS Service or Licensor’s computer systems regarding configuration, environment, usage, performance, vulnerabilities and security of the SaaS Software or SaaS Service that may be used to generate logs, statistics and reports regarding performance, availability, integrity and security of the SaaS Software.

  • Database Management System (DBMS) A system of manual procedures and computer programs used to create, store and update the data required to provide Selective Routing and/or Automatic Location Identification for 911 systems. Day: A calendar day unless otherwise specified. Dedicated Transport: UNE transmission path between one of CenturyLink’s Wire Centers or switches and another of CenturyLink’s Wire Centers or switches within the same LATA and State that are dedicated to a particular customer or carrier. Default: A Party’s violation of any material term or condition of the Agreement, or refusal or failure in any material respect to properly perform its obligations under this Agreement, including the failure to make any undisputed payment when due. A Party shall also be deemed in Default upon such Party’s insolvency or the initiation of bankruptcy or receivership proceedings by or against the Party or the failure to obtain or maintain any certification(s) or authorization(s) from the Commission which are necessary or appropriate for a Party to exchange traffic or order any service, facility or arrangement under this Agreement, or notice from the Party that it has ceased doing business in this State or receipt of publicly available information that signifies the Party is no longer doing business in this State.

  • Market Analysis means a technique used to identify market characteristics for specific goods or services “National Treasury” has the meaning assigned to it in section 1 of the Municipal Finance Management Act, 2003 (Act No. 56 of 2003);

  • Log means the up-to-date log that is used to track all Modifications to the Facility since the date of this Certificate as required by the Documentation Requirements conditions of this Certificate.

  • Filter means material placed in the useful beam to preferentially absorb selected radiations.

  • HCPCS means the Healthcare Common Procedure Coding System.

  • Comprehensive resource analysis means an analysis including,

  • Catalogue means the catalogue of IT Products available for Order under the provisions of the Framework Agreement.