Screening Epoch Disposition eCRF

Treatment/Run-in/Follow-up Epoch Disposition eCRF

Study Treatment Disposition eCRF

eCRF Completion Instructions for End of Epoch disposition At the end of each epoch, a Disposition event CRF must be completed. These CRFs collect information on the subject status – whether they completed and if the subject discontinued the primary reason for discontinuation. It is important to consider whether the subject discontinued for reasons related to safety (e.g. Adverse Experiences, Death) or reasons related to efficacy (e.g. Lack of Efficacy, Disease Progression, No Longer Requires Treatment ) If the subject is discontinuing for reasons NOT related to efficacy or safety then indicate one of the other available reasons (list provide below). These other reasons must not be used when the underlying reason is related to Adverse Events or Lack of Efficacy.

eCRF Completion Instructions for End of Study Treatment eCRF This CRF is only needed in trials where the End of Study Treatment is different from End of <Treatment> Epoch completion, such as Outcome driven trials, where the End of Study Treatment needs to be captured outside of the End of Study disposition page. In these studies both disposition pages, i.e. End of Study Treatment and End of <Treatment> Epoch completion will be needed in the <Treatment> Epoch. Study teams must decide if this page is needed within the trial. This CRF should be completed when:   A subject discontinues study treatment prior to the end of the epoch. A subject completes the study treatment in the epoch.