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”). (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 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.
Examples of Investigator Brochure in a sentence
For the purposes of this Agreement, trade secrets include, but are not limited to, the Protocol, the Investigator Brochure, Attachment A, the minimum enrollment goal, the expected number of Study subjects enrolled and the expected duration of the Study.
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 in human 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) který obsahuje hlavní bezpečnostní informace, jež by se měly objevit na označení přípravku.
Investigator Brochure means, in accordance with the definition in 21 CFR Part 312.23(a)(5), a document containing information about the Licensed Compound, 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 Licensed Compound or related drugs, and precautions, such as additional monitoring, to be taken as part of the investigational use of the Licensed Compound.
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;
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. (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. (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 # […***…]