Computer-implemented method for the processing and/or creation of clinical trial protocol documentation

A computer-implemented method for processing and/or creation of clinical trial protocol documentation, the method comprising:

• obtaining an indication of the registration body for the clinical trial;
• based on the obtained indication of a registration body, determining which clinical trial documentation is required for that registration body;
• creating template documents for completion by a user based on the determination of which clinical trial documentation is required for that registration body;
• suggesting text for inclusion in the template documents based on the registration body and based on text entered by the user in other documents or other sections of the same document;
• and
• outputting completed clinical trial documentation as a coded document, in a format based on the indication of the registration body.

A computer-implemented method for processing and/or creation of clinical trial protocol documentation, the method comprising:

• obtaining completed clinical trial documentation;
• receiving a request by a user to make a change to data in a first document;
• and
• implementing the requested change to all other documents for the same clinical trial where that same data is used.

A computing device comprising a display screen, the computing device being configured to display on the screen:

• a prompt to a user to provide an indication of a clinical trial registration body;
• a prompt to a user to enter in relevant clinical trial information;
• a prompt to a user to accept suggested content for fields of clinical trial documentation;
• and
• a prompt to the user to generate and export clinical trial documentation in a format based on the clinical trial registration body.