Study Amendment

You can make changes to your ongoing study by changing to amendment mode. The changes applied in the amendment is applied study-wide. Data cannot be collected in this mode, so make sure that you plan when to make your amendments. 

Start amendment:

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

Possible actions in amendment mode:

Form amendments

• Create new forms
• Change any text (can be performed without starting amendment mode)
• Delete or edit existing validation rules
• Enable/disable toggle for decimal/whole number (will not touch the data)
• Change 'mandatory' requirements
• Add/Delete questions in forms
  • Adding a mandatory question to a form, will display a red triangle on the affected data event for all subjects who already completed the form prior to 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 prior to the amendment
  • Deleting a question from a form, 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 order of questions in a form

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 order of forms in data events
• Add/delete form(s) to/from data event(s)
  • Adding a form to a data event, will display a red triangle on the affected data event for all subjects who already completed the data event prior to 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 from a data event, 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
  • Generally, adding process validation rules in amendment mode does not affect the existing data. Therefore, if the existing data does not comply with the new process validation rules, a warning will not be automatically shown when you return to data collection mode. However, if you update an already answered question within one of the affected forms and the new answer does not comply with the new process validation rules, then the new rule will be triggered.

• 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 site's name

Finish amendment:

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

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.