Phase conclusion
If the subject met the definition of a protocol completer = 'No' and enter the date the subject completed treatment/Week 4 follow up (depending on amendment status at site at that time) If the subject did not meet the definition of a protocol completer = 'Yes', the date the subject failed to complete (e.g., date study treatment was prematurely and permanently stopped) and enter the reason the subject did not complete
text
day month year
date
If you tick adverse event, record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. Only tick Investigator discretion if none of the other primary reasons are appropriate. If you tick Investigator discretion, please specify in the following item.
integer
Subject withdrawal, Investigator discretion
text
Attention Study Investigator Please complete the Phase Conclusion form according to the definitions in the instructions above. However, please only **sign** this form after completion of Week 4 FU for all subjects (both pre and post protocol amendment Is all data entered and accurate for all previous visits (including 4 weeks of follow up) and associated log pages? This data may be used for an interim analysis and some or all of this data may be submitted to regulatory authorities. If Yes, then click the Sign button at the bottom of this form to provide Interim data sign-off.
boolean
Investigators signature
text
By ticking or unticking this box you are evoking a change to this form that will invalidate the original signature and will revert the form back to an unsigned state.This should be done when significant changes (e.g. those that require medical opinion or other significant situations) occur after the original signature. If the box is already ticked upon arrival on this form, unticking and submitting it accomplishes the same task as ticking and submitting it; that is, the signature will be invalidated in both instances.
boolean