Cel Sci Corporation (CVM)

[Biobonic]

A recent tweet authored on May 21 (a communication limited to 280 characters)

Statistical analysis plan was signed before database lock in December. The statistical analysis, blinded to $CVM , was started then. Full data analysis because (first-in-human). Work of ICON gets double checked by another group. When done, final report and data announcement.


My interpretation:

The Statistical Analysis Plan included the double check by another group.

This was blinded to CVM, as the Statistical Analysis Plan is prepared by the CRO.

SAP Info

6. Roles and Responsibility – signatures

Item 6a: Signature of person writing the SAP

Explanation
The signature of the person writing the SAP is crucial as it identifies who is responsible for the SAP and
that they have approved the SAP. In all circumstances this should be signed and dated. If an update
has been made then the author of the update should sign the updated version.

Item 6b: Signature of senior statistician responsible

Explanation
The signature of the senior statistician responsible for overseeing the trial is important as it highlights
that the SAP has been reviewed and approved by an experienced statistician. In some circumstances
the senior statistician may be the person writing the SAP and such a dual role should be reflected in
the signatories. The signature should always be dated.

Item 6c: Signature of chief investigator/clinical lead

Explanation
The signature of the chief investigator/clinical lead demonstrates that they have reviewed and
approved the SAP. Once the final version has been approved and signed off it avoids any post-hoc
changes being made without the justification and approval of all signatory members to maintain
internal and external trial validity. The signature should always be dated.

But then again, I'm only the piano player.