Report Synopsis definition

Report Synopsis a summary of the results of the Clinical Trial written by or on behalf of the Charity in accordance with the Charity’s Standard Operating Procedures in a form substantially similar to the format set out in Schedule 2 and the format of the clinical study synopsis set out in Annex I of ICH Topic E3 of the ICH Guidelines for Structure and Content of Clinical Study reports dated July 1996. The Report Synopsis shall not include or contain any additional documents or any appendices, exhibits or annexes nor shall it include or contain any Data Listings, Case Report Forms or any raw data comprised within the Clinical Trial Results or cover any Long Term Survival Data.
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Examples of Report Synopsis in a sentence

  • Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within twelve (12) months of Clinical Trial completion, Xxxxxxx or its designee may post the results of the Clinical Trial to a clinical trial results web site in the form of a Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

  • Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within twelve (12) months of Clinical Trial completion, Janssen or its designee may post the results of the Clinical Trial to a clinical trial results web site in the form of a Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

  • Recognizing that the Town would need to come up with $2,000 more money to fund this study, the Mayor recommended that the Town Council approve an additional allocation of $2,000 from the General Fund to fund this study.

  • This section provides with a general insight into the basic structure of the Master Plan, explaining: - Structure of the Final Report;- Synopsis of the Strategic Framework; and- Profile of the Health Master Plan Study.

  • ChecklistAPPLICATION FORM____________For(Approval from Ethical Review Committee) This checklist is prepared in order to facilitate an investigator in preparing a complete application and to help Research Ethical Committee for expedited review.PRINCIPAL INVESTIGATOR’S NAME:DESIGNATION:DEPARTMENT: One copy of ERC Application form with checklist One copy of Theses/ Research Report/ Synopsis in standard format One copy of informed consent in English and Urdu or any other local language of the population study.

  • Informational Items: Items included in the packet were the NorthCare Network Board Report, MI Health Link Report, and Penetration Report Synopsis.

  • You should then email your completed Personalised Report Synopsis to professionalreviews@theihe.org asking for it to be approved.

  • Id. On July 1, 1999, Petitioner was transferred.2 His classification file was also transferred at this time.

  • We aim to grant Personalised Report Synopsis approval within about eight weeks, but in some circumstances it may take longer.

  • Clinical Study Report Synopsis [D5890L00008]: A comparison of the efficacy of Symbicort SMART (Symbicort)Turbuhaler 160/4.5 mg 1 inhalation b.i.d. plus as- needed) and conventional best standard treatment for the treatment of persistent asthma in adolescents and adults.

Related to Report Synopsis

  • Case Report Form means a printed, optical or electronic document or database designed to record all of the information, which is required by the Protocol to be reported to the Sponsor on each Study Participant.

  • Compliance Statement is that certain statement in the form attached hereto as Exhibit B.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • GLJ Report means the independent engineering reserves evaluation of certain oil, NGL and natural gas interests of the Company prepared by GLJ dated February 11, 2022 and effective December 31, 2021.

  • Root Cause Analysis Report means a report addressing a problem or non-conformance, in order to get to the ‘root cause’ of the problem, which thereby assists in correcting or eliminating the cause, and prevent the problem from recurring.

  • Technical Report means a report prepared and filed in accordance with this Instrument and Form 43-101F1 Technical Report that includes, in summary form, all material scientific and technical information in respect of the subject property as of the effective date of the technical report; and

  • Data Package has the meaning set forth in Section 2.9(a).

  • Information Package means the most recent compilation of financial and other data with respect to the Failed Bank, including any amendments or supplements thereto, provided to the Assuming Institution by the Corporation on the web site used by the Corporation to market the Failed Bank to potential acquirers.

  • Operating Statement Analysis Report format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CREFC® Operating Statement Analysis Report The monthly report in the “Operating Statement Analysis Report” format substantially in the form of and containing the information called for therein for the Mortgage Loans, or such other form for the presentation of such information as may be approved from time to time by the CREFC® for commercial mortgage securities transactions generally.

  • CREFC® Investor Reporting Package® shall have the meaning assigned to such term or an analogous term in the Servicing Agreement.

  • Phase III Clinical Study means a pivotal Clinical Study, the results of which could be used to establish safety and efficacy of a Licensed Product in the Field as a basis for Regulatory Approval or that would otherwise satisfy requirements of 21 CFR 312.21(c), or its foreign equivalent.

  • 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.

  • CREFC® REO Liquidation Report Template A report substantially in the form of, and containing the information called for in, the downloadable form of the “REO Liquidation Report Template” available as of the Closing Date on the CREFC® Website, or such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CREFC® for commercial mortgage securities transactions generally.

  • CMSA Operating Statement Analysis Report means a report substantially in the form of, and containing the information called for in, the downloadable form of the "Operating Statement Analysis Report" available as of the Closing Date on the CMSA Website or in such other form for the presentation of such information and containing such additional information as may from time to time be approved by the CMSA for commercial mortgage-backed securities transactions generally.

  • Assessment Report : means the assessment report referred to in Articles 32(2) and 33(3) of Regulation (EC) No 834/2007 drawn up by an independent third party fulfilling the requirements of ISO Standard 17011 or by a relevant competent authority, which includes information on document reviews, including the descriptions referred to in Articles 4(3)(b) and 11(3)(b) of this Regulation, on office audits, including critical locations and on risk-oriented witness audits conducted in representative third countries.

  • Summary Subcontract Report (SSR) Coordinator, as used in this clause, means the individual at the department or agency level who is registered in eSRS and is responsible for acknowledging or rejecting SSRs in eSRS for the department or agency.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • SOS Reports means the official reports from the Secretaries of State of each Collateral State, Chief Executive Office State and the Borrower State and other applicable federal, state or local government offices identifying all current security interests filed in the Collateral and Liens of record as of the date of such report.