Clinical Safety Data definition

Clinical Safety Data means all safety and tolerability data from the monotherapy portions of the Collaborator Clinical Trial or other monotherapy clinical trials involving the Collaborator Compound, including all safety reports containing information on adverse events, SAEs, and other information required by any FDA-reporting requirements, including summary tables of laboratory and radiographic data. [***] = Certain confidential information contained in this document, marked by brackets, is omitted because it is not material and would be competitively harmful if publicly disclosed.
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Clinical Safety Data means all safety-related data and results from the Monotherapy Arm [***] include safety reports containing information on adverse events, SAEs, and compilations and analyses to satisfy any FDA-reporting requirements, including summary tables of laboratory and radiographic data.
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Clinical Safety Data means all safety and tolerability data [***].
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Examples of Clinical Safety Data in a sentence

  • The study will comply with the requirements of the ICH E2A guideline (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

  • In general, the format of the post-market adverse event report should follow the model for a periodic safety update report described in the Guidance for Industry E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs and the Guidance addendum.

  • An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

  • An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product) (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

  • Such expedited reports should comply with the applicable regulatory requirement(s) and with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.

  • Any untoward medical occurrence that at any dose:- results in death,- is life-threatening,- requires inpatient hospitalization or prolongation of existing hospitalization,- results in persistent or significant disability/incapacity, or- is a congenital anomaly/birth defect(see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).

  • Clinical Safety Data Management: Definitions and Standards for Expedited Reporting and recommended for adoption at Step 4 of the ICH process on 27 October 1994.3. International Reporting of Periodic Drug-Safety Update Summaries.

  • The PSUR or PBRER should be compiled in accordance with the requirements of the current ICH E2C Expert Group on Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs.

  • In general, the format of the post- market adverse event report should follow the model for a periodic safety update report described in the Guidance for Industry E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs and the Guidance addendum.

  • Determining whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the ICH Guidance for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).


More Definitions of Clinical Safety Data

Clinical Safety Data means all safety and tolerability data from the portions of the Collaborator Clinical Trial that do not contain the MSD Compound or other clinical trials involving the Collaborator Compound, including all safety reports containing information on adverse events, SAEs, and other information required by any FDA-reporting requirements, including summary tables of laboratory and radiographic data..
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Clinical Safety Data means all safety and tolerability data from the Monotherapy Arm(s) of the Intensity Clinical Trial involving the Intensity Compound, which data is presented at Intensity’s safety review meeting and include safety reports containing information on adverse events, SAEs, and any FDA-reporting requirements, including summary tables of laboratory and radiographic data.
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Related to Clinical Safety Data

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Material safety data sheet or "MSDS" means the chemical, physical, technical, and safety information document supplied by the manufacturer of the coating, solvent, or other chemical product, usually through the distribution network or retailers.

  • health and safety file means a file, or other record containing the information in writing required by these Regulations "health and safety plan" means a site, activity or project specific documented plan in accordance with the client's health and safety specification;

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Safety Data Sheet means a safety data sheet within the meaning of regulation 5 of the CHIP Regulations;

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • health and safety specification means a site, activity or project specific document prepared by the client pertaining to all health and safety requirements related to construction work;

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Civil Aeronautical Product means any civil aircraft, aircraft engine, or propeller or subassembly, appliance, material, part, or component to be installed thereon.

  • Waste Materials means any Contamination-causing solid, semi-solid, or liquid material discarded, buried, or otherwise present on the Property, and may include sludge, slag, or solid waste materials such as empty containers and demolition debris or materials containing asbestos, lead-based paint, or petroleum or other contaminants.

  • Safety zone means the area officially set apart within a roadway for the exclusive use of

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.