Reference Safety Information definition

Reference Safety Information means the recognized Adverse Reactions to the Shire Product contained in all or any one of Shire’s Developmental Core Safety Information (DCSI) in an investigator’s brochure, Shire’s Company Core Safety Information (CCSI) in a marketed product Company Core Data Sheet (CCDS) and Shire’s official local product labeling (including the local Summary of Product Characteristics (SPC)).
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Reference Safety Information means the recognised Adverse Reactions to the Product contained in all or any one of VGN’s Developmental Core Safety Information (DCSI) in an investigator’s brochure, VGN’s Company Core Safety Information (CCSI) in a marketed product Company Core Data Sheet (CCDS) and either VGN’s or SOI’s official local product labeling (including the local Summary of Product Characteristics (SPC));
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Reference Safety Information means a list of medical terms detailing the adverse reactions that are expected for the Product, as applicable; provided that, as it applies to conduct of a Clinical Trial, the list details serious adverse reactions (SARs) that are expected for such Product, as applicable, and is to be used by investigators as a reference point when assessing a SAR to determine whether it is a suspected unexpected serious adverse reaction.
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Examples of Reference Safety Information in a sentence

  • Sections 5.6.1 and 5.6.2 in the Investigator Brochure (IB) represent the Reference Safety Information to determine expectedness of serious adverse events for expedited reporting.

  • Checking for (annually) and notifying PIs of updates to the Reference Safety Information for the trial.

  • For the purposes of this trial, the Reference Safety Information (RSI) for apixaban will be used, available at www.medicines.org.uk/emc/product/2878/smpc.

  • This Part shall not prevent the application of wider domestic provisions relating to the effect of ne bis in idem attached to foreign criminal judgments.

  • The SPC (section 4.8«Bivirkninger») of the IMPs is used as Reference Safety Information (RSI) in this trial.

  • The Reference Safety Information (RSI) is used for the assessment of the expectedness of all ‘suspected’ SARs that occur in clinical trials.

  • An initial assessment of expectedness/listedness for SAEs will be conducted by the PI based on the Reference Safety Information (RSI).Participants discharged from hospital before the end of trial will be given a diary to record adverse events, this will be used as an aide memoire for them to report AEs at the telephone follow-up call.

  • See the Reference Safety Information in the acalabrutinib Investigator’s Brochure for assessment of expectedness of serious adverse reactions.

  • Using medical judgement in assigning seriousness, causality and expectedness using the Reference Safety Information approved for the trial.

  • FASS is used as Reference Safety Information for assessing whether an adverse event is expected or not.


More Definitions of Reference Safety Information

Reference Safety Information means safety information by which the Party responsible for the Global Safety Database as set forth in this Agreement assess expectedness and according to which events are assessed for regulatory safety reporting to Regulatory Authorities. (e.g. Investigator Brochure (IB), Company Core Data Sheet (CCDS), local label). [*] Confidential Treatment Requested.
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Reference Safety Information means the recognized Adverse Reactions and other warnings or precautions relating to the Product contained in all or any of Salix’s approved product labeling, including the US Package Insert (USPI) or the most recent version of the Investigator Brochure (IB).
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Related to Reference Safety Information

  • Contractor Sensitive Information means any information provided by the Contractor to the Authority (disregarding any protective marking or assertion of confidentiality) which: is specified as Contractor Sensitive Information in Schedule 7 and has not lost its sensitivity according to the justifications and durations set out in that Schedule; and is exempt information pursuant to sections 33(1) or 36, 38 or 39 of FOISA (having regard for that purpose to the public interest there might be in disclosing such information as referred to in section 2(1)(b) of FOISA).

  • Transparency Information means the content of this Contract in its entirety, including from time to time agreed changes to the Contract, and details of any payments made by the Authority to the Contractor under the Contract;

  • Appendix Information means the information which must be provided for the selected modules as set out in the Appendix of the Approved EU SCCs (other than the Parties), and which for this Addendum is set out in:

  • Data Room Information means the information and documents listed in the index of documents contained in the Data Site attached to the Company Disclosure Letter;

  • Third Party Information means confidential or proprietary information subject to a duty on the Company’s and its affiliates’ part to maintain the confidentiality of such information and to use it only for certain limited purposes.

  • Confidential System Information means any communication or record (whether oral, written, electronically stored or transmitted, or in any other form) provided to or made available to Grantee; or that Grantee may create, receive, maintain, use, disclose or have access to on behalf of HHSC or through performance of the Project, which is not designated as Confidential Information in a Data Use Agreement.

  • Client Information means any data, information, software or other materials that you provide to Red Hat under the Agreement.

  • DXC Sensitive Information means DXC Confidential Information, Intellectual Property, PHI, DXC Customer data, and Personal Information.

  • Access Information means information that alone or together with other information, can provide access to any portion of Your Account, including but not limited to, Your Account number, login names, passwords, credit card or other financial information, security questions and their respective answers, and any other similar information. For the avoidance of doubt, Your Access Information will include any similar information for each of Your Users.

  • Directory information means information contained in an education record of a student which would not generally be considered harmful or an invasion of privacy if disclosed. It includes, but is not limited to: the student’s name, address, telephone listing, electronic mail address, photograph, date and place of birth, major field of study, dates of attendance, grade level, enrollment status (i.e., full-time or part-time), participation in officially recognized activities and sports, weight and height of members of athletic teams, degrees, honors and awards received, and the most recent educational agency or institution attended. It also includes the name, address, and telephone number of the student’s parent(s). Directory information does not include:

  • Patient Information means information (however recorded) which—

  • Contractor information system means an information system belonging to, or operated by or for, the Contractor.

  • Biometric information means any information, regardless of how it is captured, converted, stored, or shared, based on an individual’s biometric identifier used to identify an individual. Biometric information does not include information derived from items or procedures excluded under the definition of biometric identifiers.

  • Confidential commercial information means records provided to the govern- ment by a submitter that arguably contain material exempt from release under Exemption 4 of the Freedom of Information Act, 5 U.S.C. 552(b)(4), be- cause disclosure could reasonably be expected to cause substantial competi- tive harm.

  • Regulatory Information Service means a service approved by the London Stock Exchange for the distribution to the public of announcements; and

  • Authority's Confidential Information means all Personal Data and any information, however it is conveyed, that relates to the business, affairs, developments, trade secrets, know-how, personnel, and suppliers of the Authority, including all IPRs, together with all information derived from any of the above, and any other information clearly designated as being confidential (whether or not it is marked "confidential") or which ought reasonably be considered to be confidential;

  • Company Information As defined in Section 4(a)(i).

  • Keeping information confidential means using discretion in disclosing information as well as guarding against unlawful or inappropriate access by others. This includes:

  • Program Information is defined in Section 13.8(a)(i).

  • Supplier's Confidential Information means any information, however it is conveyed, that relates to the business, affairs, developments, trade secrets, Know-How, personnel and suppliers of the Supplier, including IPRs, together with information derived from the above, and any other information clearly designated as being confidential (whether or not it is marked as "confidential") or which ought reasonably to be considered to be confidential;

  • Sensitive Information means controlled unclassified information of a commercial, financial, proprietary, or privileged nature. The term includes technical data and computer software, but does not include information that is lawfully, publicly available without restriction.

  • Private information means **personal information in combination with any one or more of the following data elements, when either the personal information or the data element is not encrypted or encrypted with an encryption key that has also been acquired:

  • Business Confidential Information has the meaning set forth in Section 5.04(a).

  • Property Information has the meaning specified in Section 4.03.

  • Benchmarking Information means information generated by Portfolio Manager, as herein defined including descriptive information about the physical building and its operational characteristics.