Once a study has the status of Open, indicating that you are now collecting live data, only limited changes may be made to the study definition to ensure that any existing subject data remains valid and accessible.
To avoid accidental changes, you will be asked to confirm your action if you try to add an eForm or change an existing eForm into a repeating eForm once a study has been opened.
If you need to make changes to an open study, we strongly recommend that you perform your own risk and impact assessment on data integrity. We also recommend that you make a copy of the study definition first. Be aware that importing this copy at a later stage would overwrite the existing one and so would invalidate any subject data entered since the backup was taken. A 'Study Update Checklist' is available from the community site and lists the steps required when making an updated study live.
If you suspect that a study may contain corrupt data you can use the Study Data Diagnostic Utility (SDDU) to identify any invalid data. Help on this..
If you change a study definition that is being used by a remote site, you must distribute the updated study definition to the site for them to see the changes.
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Changes that CAN be made to an open study |
Changes that CANNOT be made to an open study |
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Add new eForms, visits, question definitions |
Delete eForms, visits and question groups |
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Edit and delete questions added within the current session, and remove newly-created questions from a question group or eForm within the current session. This refers to all questions created or duplicated within any individual study (but not to questions copied between studies). |
Delete already existing questions and remove already existing questions from question groups. These are questions that were created or added to the question group in a previous session. |
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Add questions to eForms, add eForms to visits |
Remove already existing questions from eForms. These are questions that were added to an eForm in a previous session. |
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Add or re-order questions in a question group |
Remove eForms from the schedule |
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Add or re-order category values in a category question definition |
Delete category options within a category question definition |
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Make category values inactive/active |
Change category options within a category question definition |
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Change question derivations |
Change question types |
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Add, change or delete question 'Warning' and 'Inform' validation conditions |
Change the format of a question |
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Delete question 'Reject if' validation conditions |
Add or change question 'Reject if' validation conditions |
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Change eForm 'Collect if' conditions |
Change any uniqueness checks or identifier numbering used for subject registration |
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Change question captions |
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Change eForm layouts, colours and fonts |
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Hide visible questions or re-display invisible questions |
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