The initial Protocol Statement of Support (PSOS) has been updated (version 4- dated 8 Dec 2021).
And is now available on the Scientific Review Committee (SRC) website to download.
Key update: An additional question regarding interim efficacy or safety analysis was added to the “scientific importance of the study” section.
Scientific Importance of Study
D. Is an interim efficacy or safety analysis included in the study design of this protocol:
If not Included, provide the justification of not including it in the study design.
For industry sponsored trials, the justification of not including efficacy or safety analysis in study design should be discussed with the sponsor.
In case of any questions, please reach out to the SRC office at firstname.lastname@example.org
Kindly make sure you are using this revised version going forward. CCTO intake will reject all the old versions of PSOS if they have a CRG meeting date of February 15 or later.