Statistical study definition
Statistical study means any project consisting of or based on assembling, classifying, and/or tabulating numerical data to present significant information about a given subject.
Statistical study means any project consisting of or based on assembling, classifying, and/or tabulating numeri- cal data to present significant information about a given sub- ject.
Statistical study. The results section is assumed to be based on the 209 tables specified in Appendices 1 and 2 (153 tables identical to Action II ISS tables, and 77 additional tables). It is assumed that methods and results sections covering plasma pimagedine data and Quality of Life will be written by their corresponding vendors or will be written by, (including relationship of plasma pimagedine to efficacy or safety) Alteon. It is assumed that these sections will be supplied to Quintiles as drop-in sections and that these will use section numbering as specified by Quintiles. Further, it is assumed that text covering results for Quality of life and plasma pimagedine data for the ISE (and for the ISS if appropriate) will be supplied as a drop-in section. Quintiles has assumed that an integrated set of comments is received from Alteon within * days of shipment of each batch of ISS or ISE tables. Further, Quintiles has assumed that draft tables will be revised to produce final tables as indicated by the integrated comments from Alteon, within at most * weeks of receipt of comments, except for the last batch of ISE tables where revised tables will be shipped within * of receiving comments. This timeline assumes that as a result of Alteon's comments on each batch of ISS or ISE tables, no new tables are required, no additions to tables are required, no changes are made to any definitions, and no additional exploratory analyses are needed. Quintiles has assumed that Alteon is able to obtain FDA agreement to the ISS ARO, the ISE ARO, and the data analysis rules for the ISS and ISE by *. Quintiles also assumes that no additional analyses are required as a result of the Pre-NDA meeting scheduled for *. If such additional analyses are required then these will be billed on a fee-for-service basis and this is likely to impact on the NDA timeline. Quintiles has assumed that all data on patients who are lost to follow-up (including any additional data collected as a result of active searching for these lost to follow-up patients) is received at Quintiles by * for Action I patients and by * for Action II patients. Quintiles has assumed that the last DCF for any data retrieved for lost to follow-up patients is resolved by * for Action I patients and by * for Action II patients. Any delays in receipt of this information may lead to delays in all subsequent dates on the timeline. This budget estimate does not include costs for Quintiles to scan CRFs. Any support provided by Quintiles in conn...