Technical Specification. The CTSU will provide a first draft of the Technical Specification to the CSC for review. The Technical Specification contains information valid for the study including: · Study design · Randomisation numbers and their syntax, strata label and period (if applicable) · Estimated Times Frames · Participating Countries · Description of Packs and Labelling · Calculation of IMP Requirements · Despatch Requirements · Return & Product destruction requirements · Approval of master and translated labels by Ipsen local affiliates or by central regulatory affairs. The CSC completes, reviews and returns the Technical Specification to the CTSU for finalisation. Both CSC and CTSU agree on packaging design, presentation of the IMP and on timelines for setting up the IMP. The CSC and CTSU representative must ensure and document that the Technical Specification is consistent with the final approved protocol. The Technical Specification represents the official agreement between the CTSU and the CSC on IMP specifications.
Appears in 4 contracts
Samples: License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.), License Agreement (Radius Health, Inc.)
