Amendment mode will allow you to quickly adapt to changes in protocol and make amendments to your ongoing study.

To start the Amendment:

  1. Go to [Study Name] > Study Info.
  2. Click Study Amendment button, type in the study name in capital letters and click Confirm.
  3. Your study will change the Status from Collecting Data to Amendment.

When your study is in Amendment Mode, you can perform the following actions:

  • Change any text
  • Edit min/max length
  • Delete or edit validation rules IF no data has been collected using the form
  • Toggle decimal/whole number (will not touch the data)
  • Create, edit and delete Reference Rules
  • Change 'mandatory' requirements
  • Add/Delete questions in forms
  • Question types can be changed ONLY if no data has been collected using that question
  • Change between Dynamic and Static table
  • Change order of questions in a form
  • Change the process ONLY if there are no subjects enrolled to the site
    • i.e. you cannot add or remove data events or change data event order if any subjects are enrolled
  • Add/Remove form(s) to/from data event(s)
  • Change order of forms in data event
  • Create new site and edit site's name and geographical location
  • Create new forms
  • Create new process

You cannot edit possibilities or change question visibility rules on existing questions that have been used to collect data. If you have issues with amendment, please contact support, and we'll do our best to help you.


How to finish the Amendment:

  1. Go to [Study Name] > Study Info.
  2. Click Finish Amendment, type in the study name in capital letters and click Confirm.

  3. Your study will change the Status from Amendment to Collecting Data, and all changes will be applied.

Once the Amendment has been finished and all changes are applied, it is not possible to "undo" the changes nor restore the study to its previous state.



How to discard all changes:

  1. Go to [Study Name] > Study Info.
  2. Click Discard Amendment, type in the study name in capital letters and click Confirm.

  3. Your study will change the Status from Amendment to Collecting Data, and no changes will be applied.



Can't find the answer you're looking for?

Don't hesitate to raise a support request via support@smart-trial.co.