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Clinical trial notification (CTN) form - user guide

V1.2, August 2020

21 August 2020

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Validation and submission

The CTN form must be validated before it can be submitted to us.

Before selecting validate, you will need to save your draft as described in the Save a draft section above.

All mandatory fields must be completed for the form to validate.

Validating the form

To validate the form, select the Validate button at the top left of the form.

screenshot showing the Validate button at the top of the CTN form

The validation process checks that all compulsory fields are completed, and that information has been entered in the correct format (e.g. email addresses).

Validation messages and automatic submission

After selecting the Validate button, you will be taken to the Validation messages tab.

The Validation messages tab displays a list of fields that need to be corrected before validation can proceed.

If there are validation messages displayed:

  • The status of the notification form will change to Draft Not Valid.
screenshot showing Draft Not Valid status
  • Select a validation message in the list. This will take you to the field in the form that requires editing.
screenshot showing a list of Validation messages
  • Once you have corrected all the invalid fields, save the form and validate again.
  • You will need to correct all errors and successfully validate your draft to be able to submit it.

If there are no validation messages:

  • The status of the notification form (top right of window) will change from Draft to Validated.
screenshot showing Validated status
  • The validation messages tab will display the message 'No validation messages to display'.

Once the form has validated, Submit will appear at the top of the page next to Validate. If you select this button, you will be automatically taken to the submissions page for submitting your CTN.

screenshot showing Close button at the top of the CTN form

If you select the Save button again after successfully validating the form, it will revert back to draft status and you will need to validate the form again before you can submit it. Remember to complete the steps as follows:

Save then Validate then Close

After validating and submitting the form, you will be taken to the 'Clinical Trials Submissions' page as displayed in Option 2 of the Manual Submitting section.

Alternatively, if you need to edit the validated form again for any reason (prior to submission), it can be accessed by selecting View Drafts on the Portal menu. See Edit a saved draft for more information. You will be required to save and validate the CTN again to ensure the information has been updated before submitting.

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