News

Patients reaching Visit 15

We have now passed the five year point of the SPIRIT 2 study with some participants reaching visit 15 (the end of study).  In addition to visit 15 data, updates to the study drug log and patient outcome pages are required at this point. These updates are as follows:


Study Drug Log
Imatinib patients
-   A permanent discontinuation of study drug should be recorded.
-   The discontinuation date will be the visit 15 date.
-   The drug dose should be recorded as 0 mg.
Dasatinib patients who will continue to receive study Dasatinib after visit 15
-   A permanent discontinuation of study drug should be recorded.
-   The discontinuation date will be the visit 15 date.
-   The drug dose should be entered as 100 mg.
-   A comment should then be entered against the page to reflect that follow-up supply of Dasatinib will continue.
-   When these patients stop receiving study Dasatinib another permanent discontinuation should be recorded with an updated stop date and dose of 0 mg.
Dasatinib patients who will not continue to receive study Dasatinib after visit 15
-   A permanent discontinuation of study drug should be recorded.
-   The discontinuation date will be the visit 15 date.
-   The drug dose should be recorded as 0 mg.
 
Patient Outcome Page
Imatinib and Dasatinib Patients
-   The patient outcome page should be completed for all patients.
-   The discontinuation reason will be 'Study finished'.
 
The eCRF completion guidance document is currently in the process of being updated. The updated version will be circulated in due course.

Last modified: Fri, 20 Jan 2017 14:27:34 GMT