Statistical Analysis Plan has the meaning set forth in Section 4.5.6.
Statistical Analysis Plan means a document that is prepared for the purpose of a Clinical Trial, that is approved by the DCC and that pre-specifies the statistical analyses to be performed (statistical methods, endpoint definitions, analysis sets and principles for the handling of missing data) and how the results from the relevant Clinical Trial will be presented. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Statistical Analysis Plan means the set of analyses of the Study Data for each Combined Therapy Trial conducted hereunder prepared by BioXcel (in consultation with Nektar) and approved by the JDC and shall include safety analyses for the Combined Therapy in each Combined Therapy Trial. The Statistical Analysis Plan document for a Combined Therapy Trial will be agreed to by the JDC before Database Lock and any material amendments thereto will require JDC approval.
Examples of Statistical Analysis Plan in a sentence
Prior to the analysis of the final study data, a detailed Statistical Analysis Plan (SAP) will be written describing all analyses that will be performed.
Specific details will be provided in the Statistical Analysis Plan.
Please submit all versions of the protocols (and Statistical Analysis Plan) and the date when changes were implemented.
ABBREVIATIONSAbbreviations pertain to the Statistical Analysis Plan (SAP) only (not the tables, figures and listings [TFLs]).
Reference ranges and markedly abnormal results (specified in the Statistical Analysis Plan) will be used in the summary of laboratory data.
More Definitions of Statistical Analysis Plan
Statistical Analysis Plan shall have the meaning assigned in Section 5.1(g).
Statistical Analysis Plan means the agreed-upon (at the JDC) set of analyses of the Study Data for each Combined Therapy Study conducted hereunder and shall include all analyses of the Combined Therapy in such Combined Therapy Study as specified in the Protocol. The Statistical Analysis Plan shall be set forth in a Statistical Analysis Plan document in accordance with Section 2.1(b).
Statistical Analysis Plan means the set of analyses of the Study Data for each Combined Therapy Trial conducted hereunder prepared by Five Prime (in consultation with BMS) and approved by the JDC in accordance with Section 2.4(d), which shall include safety analyses for the Combined Therapy in each Combined Therapy Trial.
Statistical Analysis Plan means the agreed-upon set of analyses of the Study Data for each Combined Therapy Study conducted hereunder and shall include all analyses of the Combined Therapy in such Combined Therapy Study as specified in the Protocol. The Statistical Analysis Plan shall be set forth in a Statistical Analysis Plan document in accordance with Section 2.1(b).
Statistical Analysis Plan has the meaning ascribed to such term in Section 3.5.6.
Statistical Analysis Plan means the set of analyses of the Study Data for each Collaboration Study conducted hereunder prepared by the Lead Party and approved by the JDC and shall include safety analyses for the Monotherapy or Combined Therapy in each Collaboration Study. The Statistical Analysis Plan document for a Collaboration Study will be agreed to by the JDC before Database Lock and any material amendments thereto will require JDC approval.
Statistical Analysis Plan means a document that prespecifies statistical analyses, focusing on statistical methods for the primary and key secondary endpoints (efficacy and safety) to be prepared by the Conducting Party for each Combined Therapy Trial. In consultation with the Non-Conducting Party, this document shall be finalized before the first formal efficacy analysis.