Investigator Brochure means the investigator brochure provided by TEKMIRA containing a detailed description of the Investigational Medicinal Product’s chemical structure and siRNA sequence, and a summary of the clinical and non-clinical data related to TKM-Ebola provided by TEKMIRA prior to the commencement of the Clinical Trial, as well as any revisions thereto that may be delivered during the course of the Clinical Trial.
Investigator Brochure. (IB) means, in accordance with the definition in 21 C.F.R. § 312.23(a)(5), a document containing information about the Test Article, including animal screening, preclinical toxicology, and detailed pharmaceutical data, including a description of possible risks and side effects to be anticipated on the basis of prior experience with the Test Article or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the Test Article.
Investigator Brochure containing all currently known information about the IMP used for the Study and its features. The Brochure shall be delivered to the Principal Investigator by the CRO and shall be made a part of the Study documentation; (iv) all conditions specified in the Statement of the Principal Investigator; (v) the ICH Harmonized Tripartite (i) povolení k provedení Klinického hodnocení vydaném Státním ústavem pro kontrolu léčiv a dalšími institucemi uvedenými ve článku 2 písm. (a) této Smlouvy; (ii) Protokolu a jeho dodatcích nebo doplňcích; (iii) souboru informací pro zkoušejícího „Investigator Brochure“ obsahujícím všechny v současnosti známé informace o Hodnoceném léčivu použitém v rámci Klinického hodnocení a jeho vlastnostech. Soubor informací bude Hlavnímu zkoušejícímu dodán CRO a bude součastí dokumentace Klinického hodnocení; (iv) veškerých podmínkách stanovených
Examples of Investigator Brochure in a sentence
An unexpected adverse event is one that is not already described in the Investigator Brochure.
This generally refers to serious adverse events that are not already identified in the Investigator Brochure and that are considered possibly or probably related to the molecule or study drug by the investigator.
Unexpected adverse events are those not listed in the Package Insert (P.I.) or current Investigator Brochure (I.B.) or not identified.
No evidence available at the time of the approval of this study protocol indicated that special warnings or precautions were appropriate, other than those noted in the provided Investigator Brochure.
Expected adverse events are those adverse events that are listed or characterized in the Package Insert or current Investigator Brochure.
More Definitions of Investigator Brochure
Investigator Brochure means a compilation of the clinical and non-clinical data on the investigational product which is relevant to the study of the investigational product inhuman study participants;
Investigator Brochure. OR “IB” A document, required in a clinical trial of an investigational new drug, which contains both clinical and non-clinical data pertaining to the drug. The document must contain, among other things: (i) a description of the drug substance and formulation, (ii) a summary of the pharmacological and toxicological effects, (iii) a summary of information relating to its safety and efficacy in humans, and (iv) a description of possible risks and adverse reactions to be anticipated, and the precautions or special monitoring that the investigator should take.
Investigator Brochure containing all currently known information about the IMP used for the Study and its features. The Brochure shall be delivered to the Principal Investigator by the CRO and shall be made a part of the Study documentation; (iv) all conditions specified in the Statement of the Principal Investigator; (v) the ICH Harmonized Tripartite Guideline for Good Clinical Practice (“ICH Guidelines”). (i) povolení k provedení Klinického hodnocení vydaném Státním ústavem pro kontrolu léčiv a dalšími institucemi uvedenými ve článku 2 písm. (a) této Smlouvy; (ii) Protokolu a jeho dodatcích nebo doplňcích; (iii) souboru informací pro zkoušejícího „Investigator Brochure“ obsahujícím všechny v současnosti známé informace o Hodnoceném léčivu použitém v rámci Klinického hodnocení a jeho vlastnostech. Soubor informací bude Hlavnímu zkoušejícímu dodán CRO a bude součastí dokumentace Klinického hodnocení; (iv) veškerých podmínkách stanovených v Prohlášení Hlavního zkoušejícího; (v) Harmonizované tripartitní směrnici ICH- GCP pro správnou klinickou praxi („směrnice ICH“). 4.
Investigator Brochure. (IB) means, in accordance with the definition in 21 C.F.R. Part 312.23(a)(5), a document containing information about the Test Article, including animal screening, preclinical toxicology, and detailed pharmaceutical data, including a description of possible risks and side effects to be anticipated on the basis of prior experience with the Test Article or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the Test Article. NIAID Intramural Clinical Trial Agreement (Clinical Center)Jasper Therapeutics-Division of Intramural Research, NIAID NIAID Protocol # […***…]
Investigator Brochure. (IB) means, in accordance with the definition in 21 C.F.R. Part 312.23(a)(5), a document containing information about the Test Article, including animal screening, preclinical toxicology, and detailed pharmaceutical data, including a description of possible risks and side effects to be anticipated on the basis of prior experience with the Test Article or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the Test Article. NIAID Intramural Clinical Trial Agreement (Clinical Center) NIAID Xxxxxxxx # 00-X-0000 Jasper Therapeutics NIAID
Investigator Brochure is a compilation of the clinical and non-clinical data on the Study Drug which is relevant to the study of the Study Drug in humans.
Investigator Brochure means a comprehensive document summarizing the body of information about an investigational product (“IP” or “study drug”) obtained during preclinical and clinical development, compiled in accordance with the principles described by the International Committee for Harmonisation; and