Clinical Study Reports generally contain numerous appendices. The ICH E3 guideline document lists recommended appendices which start in section 16 of the document. These include the trial protocol and amendments (section 16.1.1), statistical analysis plan and amendments (section 16.1.9), blank case report form (section 16.1.2), blank informed consent form (section 16.1.3), randomization scheme and codes (section 16.1.7), audit certificates (section 16.1.8), and patient data listings including discontinued patients (section 16.2.1), protocol deviations (section 16.2.2), adverse event listings for each patient (section 16.2.7), case report forms for deaths, other serious adverse events, and withdrawals for adverse events (section 16.3.1), and individual patient data listings (section 16.4).
See an example:
- 4749 pages of appendices for Rowtasha trial MA-CT-10-002
- This GSK webpage contains links to the appendices for 9 RCTs of paroxetine (Paxil)