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, ▇▇▇▇▇▇▇ 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.

  • Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within 18 months of Trial completion, Sponsor 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.

  • If the Company does not serve a written notice and pay the Full CS Report Fee as specified in this Clause 3.11, the Charity shall prepare a Report Synopsis and shall have no obligation to prepare or provide the Company with a Full Clinical Study Report.

  • If the Company does not serve a written notice and pay the Full CS Report Fee as specified in this Clause 3.10, the Charity shall prepare a Report Synopsis and shall have no obligation to prepare or provide the Company with a Full Clinical Study Report.

  • Moreover, if publication of the Clinical Trial to the peer reviewed literature has not occurred within eighteen (18) months of Trial completion, Sponsor 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, Sponsor 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, Ja▇▇▇▇▇ ▇r 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.

  • 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.

  • Navíc, pokud do dvanácti (12) měsíců od dokončení klinického hodnocení nebude klinické hodnocení publikováno v recenzované literatuře, může společnost Janssen nebo jí pověřená osoba zveřejnit Clinical Study Report Synopsis in ICH-E-3 format, if applicable.

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.

  • Reporting Material means all Material which the Grantee is required to provide to the Commonwealth for reporting purposes as specified in the Grant Details and includes any Existing Material that is incorporated in or supplied with the Reporting Material.

  • MI Reporting Template means the form of report set out in the Annex to Framework Schedule 8 (Management Information) setting out the information the Supplier is required to supply to the Authority;