Study Amendment

You can make changes to your ongoing study by changing the status of the study from "Collecting Data" to "Amendment". The changes applied in the amendment are applied study-wide. Data cannot be collected in Amendment Mode, so make sure that you plan when to make your amendments. 

 

Start amendment:

1. Go to [Study Name] > Study overview.
2. Click the 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.
   

Possible actions in amendment mode:

Form amendments

• Create new forms
• Change any text (can be performed without starting amendment mode)
• Create, Delete, or edit existing form validation rules
• Enable/disable toggle for decimal/whole number (will not affect the data)
• Change 'mandatory' requirements
• Add/Delete questions in forms
  • Adding a mandatory question will display a red triangle on the affected data event for all subjects who already completed the form before the amendment. The red triangle is removed by providing an answer for the new question or by marking the question as "Answer not available"
  • Adding an optional question to a form, will NOT display a red triangle on the affected data event for all subjects who already completed the form before the amendment
  • Deleting a question will delete any data already collected using this question. The data is also deleted from any future exports. Thus, it is always recommended to conduct an export before deleting anything if you would like to keep the data
• Question types can be changed ONLY if no data has been collected using that question
• Change between Dynamic and Static table
• Change the order of questions in a form
• Add/edit/delete possibilities
  • If data has been collected, deleting a possibility deletes this data.

In case you need to change/delete question show rules or delete rows in tables that have been used to collect data, you can contact [e-mail] as we can perform advanced amendments. 

Process amendments

• Create new process
• Change any texts (can be performed without starting amendment mode)
• Add/Remove data events ONLY if the process is not in use i.e. assigned to a site with enrolled subjects
• Change data event order ONLY if the process is not in use i.e. assigned to a site with enrolled subjects
• Change the order of forms in data events
• Add/delete form(s) to/from data event(s)
  • Adding a form will display a red triangle on the affected data event for all subjects who already completed the data event before the amendment. The red triangle is removed by providing the answers for the new questions or by marking the questions as "Answer not available"
  • Deleting a form will delete any data already collected using this form. The data is also deleted from any future exports. Thus, it is always recommended to conduct an export before deleting anything if you would like to keep the data
• Enable toggle "Unscheduled Event"
• Enable toggle "Discontinue Events"
• Enable toggle "External Events"
• Add form(s) to unscheduled events, discontinue events, and external events
• Delete form(s) from unscheduled events, discontinue events, and external events
  
  • Deleting an unscheduled event form, discontinue event form, or external event form, will delete any data already collected using this form. The data is also deleted from any future exports. Thus, it is always recommended to conduct an export before deleting anything if you would like to keep the data
• Create, edit, and delete Process Validation Rules
• Enable toggle "re-consent" for eConsent
• Discard/Upload new consent PDF for eConsent
• Change "Send As" for subject events including eConsent
• Change "Target Inclusion" for randomization
• Add randomization group(s) for randomization
• Add Stratification for randomization

Site amendments

• Create new site
• Edit the site's name

You cannot edit the site ID once the study has subjects enrolled in that specific site. You are able to update the site name but NOT the site ID.

Finish amendment:

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

Discard all changes:

1. Go to [Study Name] > Study overview.
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.

Note that there are changes that cannot be performed in Amendment mode. These changes are for example adding new process show rules, editing process show rules, changing existing form show rules, and more. If you need to amend the study but you are not able to, please write to [e-mail].

Video

Below is a video that demonstrates how to start, finish, and discard an amendment.