Notification forms to inform SÚKL

A) Non-interventional post-authorisation study initial notification form

Information on the medicinal product

SÚKL code (identification of the product)

Enter the SÚKL code in format 702 or 0000702. (non-mandatory field for PASS)

Based on the entered code, additional identification information about the medicinal product and the marketing authorisation holder are automatically loaded into the form. If the study is conducted with multiple medicinal products, the form allows an addition of multiple SÚKL codes.

Information on the study

Type of study – select one of the options. In case that the study is imposed by the regulatory authority, tick the appropriate box in the form.

As the next step, enter the study title, identification number of the study according to MAH´s documents, objectives of the study (up to 500 characters) and further characteristics of the study (choose from the options).

Study protocol

For studies conducted voluntarily by the MAH: Enter the study protocol.

For studies imposed by a regulatory authority: Enter the approved version of the study protocol and the date of approval of the study protocol. (For cases when an approved protocol is not available, enter draft version of protocol. After protocol approval, an update of web form with an approved protocol version shall be submitted.)

Attach other documents related to the study (e.g. questionnaire).

PLEASE NOTE THAT: The size of attachments included in the web form should not exceed 7,0 MB.

Dates

Enter the date of the start of data collection, expected date of the end of data collection, expected date of the end of data analysis and expected date of the final study report submission of in the dd.mm.yyyy format.

*”Start of data collection” is the date from which information about the first study subject is first recorded in the study dataset, or, in the case of the secondary use of data, the date from which data extraction starts;

* “End of data collection” is the date from which the analytical dataset is completely available.

Enter Information on person responsible for the study who will be the contact point for SÚKL.

After the form is filled-in, use the valid electronic signature to submit the form. Please note that only Czech electronic signature may be used to submit the notification. After electronic signature, ´Confirmation of receipt of data regarding a non-interventional post-authorisation study´will display on the new page. The confirmation provides basic information regarding your notification and an SÚKL identification number allocated to the study and a password are generated. Your study is now registered in the SÚKL PASS registry under this number. Make sure you save the information from the notification for a future reference (to fill-in the edit form/end-of-study notification form).

B) Non-interventional post-authorisation study edit form

If necessary, some of the entered information about the study may be changed/amended/clarified. Fields which may be changed are: Data fields and Comment. To use the edit form, it is essential to have the SÚKL identification number of the study and the password.

PLEASE NOTE THAT: The size of attachments included in the web form should not exceed 7,0 MB

C) Non-interventional post-authorisation study end-of-study notification form

The MAH is obliged to notify SÚKL electronically of the completion of a non-interventional postauthorisation safety study. The marketing authorisation holder shall submit the final study report to SÚKL within 12 months of the end of data collection. It is not possible to fill-in end-of-study form without submitting the final study report.

To use the end-of-study form, it is essential to have the SÚKL identification number of the study and the password.

Date

Enter the date of the end of data collection (according to the final study report) and the date of the final study report submission.

Final Study Report – mandatory field

Enter the final study report (pdf or doc format).

PLEASE NOTE THAT: The size of attachments included in the web form should not exceed 7,0 MB.

The field “Form of payment and site costs” is non-mandatory for PASS(intended for marketing studies).

Enter Information on person responsible for the study who will be the contact point for SÚKL.

After completing the end-of study form and submitting the form with the electronic signature, the notification is completed.