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.