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What do you need to know?
A prospective follow-up observational study with medicinal products is any observational study with medicinal products in which subjects are followed up for a period of time until the outcome variable is reached and this has not yet occurred at the start of the study.
You can learn more here.
Authority responsible
Sponsors of prospective follow-up observational studies with medicinal products which are to be performed in health sites, services and establishments in Catalonia.
Prospective follow-up observational studies with medicinal products that are sponsored by a government agency and those in which it is demonstrated that the study is a non-commercial clinical investigation are excluded. Observational studies with medicinal products with a retrospective and/or cross-sectional design and observational studies without medicinal products are also excluded.
Sponsors are required to use electronic means of communication with government agencies to carry out any administrative procedure (section 14(2) of Act 39/2015 of 1 October, BOE no. 236 of 2 October 2015, and Order PDA/20/2019 of 14 February, DOGC no. 7814 of 20 February).
You can make your application at any time
APPLICATIONS SUBMITTED ON OR AFTER 21 FEBRUARY 2023
The following documents must be attached to the application for assessment:
- Full protocol in accordance with Annex I of Royal Decree 957/2020 of 3 November regulating observational studies with medicinal products for human use.
- Favourable opinion of an Ethics Committee for Research with medicinal products (CEIm) accredited in Spain.
- List of the health sites, services and/or establishments in Catalonia where the study is to be performed.
- Case report form.
IMPORTANT: you may also submit substantial amendments once you have obtained a favourable opinion from the Directorate General for Health Planning and Regulation in the Ministry of Health to conduct the study and after the start date has been reported.
Any substantial amendment has to meet the same prerequisites for the start of the prospective follow-up observational study with medicinal products. A substantial amendment is any change which affects fundamental aspects of the study protocol, including the addition of a new publicly or privately owned site. The documentation to be submitted includes the favourable opinion of the CEIm which has assessed the study, the protocol with change control and a summary justifying the changes to be made in either of Catalonia’s two official languages.
Likewise, within one month of the effective date of completion of the authorised prospective follow-up observational study with medicinal products, the sponsor is to report the final start and end dates to the competent health planning and regulatory authority.
To submit this documentation, go to the application folder through the documentation requirements tab in your Private area, press “Submit documentation” and give a detailed description of the document. The application folder can also be accessed directly from View the status of a procedure or transaction.
STUDIES ASSESSED UNDER Order SAS/3470/2009
IMPORTANT: annual follow-up reports and the final report once the study has been concluded have to be submitted for observational studies with medicinal products which have been classified by the Spanish Agency of Medicines and Medical Devices prior to the entry into force of Royal Decree 957/2020 and which are currently in progress. An application for authorisation of substantial amendments to the study may also be submitted.
These should be submitted through the documentation requirements tab of the application folder in your Private area. You can also go straight to the application folder in View the status of a procedure or transaction.
Before sending a document, make sure that you are sending it from the relevant request by checking the name of the request and the deadline for submitting it.
When the study has been given a favourable opinion by the CEIm and prior to signing the agreement between the sponsor and the head of the health site, service or establishment where the study is to be performed, the application for assessment of compliance with the requirements for conducting the study in Catalonia must be submitted.
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Complementary informationOnce you have submitted your application together with the documents specified, you will receive the fee settlement notification showing the fees to be paid. You will also receive a request for proof of payment once payment has been made.
A prospective follow-up observational study with medicinal products cannot be begun in Catalonia without a favourable decision from the Directorate General for Health Planning and Regulation in the Ministry of Health.
Prospective follow-up observational studies with medicinal products which are sponsored by a government agency and those in which it is demonstrated that the study is a non-commercial clinical investigation are excluded from assessment. Observational studies with medicinal products with a retrospective and/or cross-sectional design and observational studies without medicinal products are also excluded.
Steps to follow
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Step one
Apply for authorisation
The following do not need to apply for an authorisation decision from the Directorate General for Health Planning and Regulation in the Ministry of Health: prospective follow-up observational studies [...]
The following do not need to apply for an authorisation decision from the Directorate General for Health Planning and Regulation in the Ministry of Health: prospective follow-up observational studies with medicinal products that are sponsored by a government agency, those in which it is demonstrated that the study is a non-commercial clinical investigation, observational studies with medicinal products with a retrospective and/or cross-sectional design and observational studies without medicinal products.
This procedure can only be done online.
It is necessary that you identify yourself when you send the form with idCAT Mòbil or a digital certificate of a natural person, legal person or person linked to an organization with representation capacity.
If you are a legal person, you must identify yourself with a representative certificate. If you are not a legal person, you can use a natural person or related person certificate.
To receive technical assistance call 012 or 932 142 124 if you do it from outside Catalonia.By Internet
Application form
Start . Go to Application formHow does the procedure need to be carried out?
The form must be filled in on line, no need to download it.
- Fill in the form and attach any documents as indicated. To attach documents you just need to click on the Attach tag and browse your computer for the desired file.
- The name of the attached file cannot contain blank spaces, hyphens, accents or diereses.
- Send the form. If you forgot some compulsory data or if any data is not correct, you will get an error message when sending and the fields that need checking will be highlighted.
- The form requires signature with a digital certificate of representation or of legal entity. You may consult the page How to sign an HTML form digital.
In the event of doubt, you are referred to the section Forms that are filled in on line at Tràmits gencat.
Checking the procedure
If the request has been sent correctly you will get proof of receipt on your screen (you need to have Adobe Acrobat to open it). It is advisable you save it, since it contains the entry register, that is, the date when the procedure started, and it may be crucial in determining the day count and deadlines.. A code also turns up identifying the procedure, which will prove useful to follow the state of the procedure on your web private Area.
If the request contains any error, the form is not sent and an error message turns up.
If you have processing problems, primer first see the recommendations in the Support to processing section on Tràmits Gencat.
Secondly, once you have checked that you have all the means needed and have completed the process as instructed, you can check whether there has been a service outage or incident in the Service Notifications and Outages section of Seu Electrònica, which contains complete information on types of incidents and where they have occurred; search for the service incidents for the year in question and sort them by the “Start date and time” field in descending order. If you are unable to complete the procedure because there is an incident in the system, please try again later.
If the incident is not resolved, please email the Pharmaceutical Planning and Quality Service at: vigimed.salut@gencat.cat.
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Step two
Pay the fee
Online payment at the time of submitting the form:
Online payment at the time of submitting the form:
With the confirmation that the form has been successfully submitted you will receive a notification that the fee is still to be paid. You can press the link to go directly to the payment page to pay by debit or credit card.
Online payment at a later date:
You can log in at any time in the Private area of the procedure with your digital ID or in View the status of a procedure or transaction with the procedure code (ID) and identification number. Once in Payments to the Administration, you can go to the platform to pay by debit or credit card.
Payment by proof of payment:
- In person: you need to access the application folder from the Private area or View the status of a procedure or transaction, download the proof of payment and pay in a bank. You can pay with a credit or debit card from any bank or a CaixaBank bankbook or current account if you have one.
- Online: you can pay here with the RIN code (a number appearing below the barcode for the settlement) which is stated on the proof of payment issued with the acknowledgement of receipt once the form has been sent.
Payment by Bizum
You can choose this method of payment when you send the form. You have to have your mobile at hand.
The telephone number that you have associated with the bank account to which you want to load with the amount will request you the platform.
Once you introduce the telephone number, you presses the button ‘Continues with the purchase’. If it suits, you will have to authorize the operation with your banking application.
The fee must be paid in order to continue processing your application. If you have not paid the fee within this deadline, your application will be deemed to have been withdrawn and your file will be closed.
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Step three
Check the status of the procedure
You can check the status of a procedure using the procedure identifier or by accessing the folder.
You can check the status of a procedure using the procedure identifier or by accessing the folder.
The procedure identifier (procedure ID) is an alphanumeric code which is generated with the submission of the application and is unique for the life of the procedure; the code is used to consult the application.
- In your Private area (with idCAT Mòbil and/or digital certificate)
- In View the status of a procedure or transaction (with the application procedure identifier and your DNI/NIF/NIE)
- By calling 012 (with the procedure identifier and your DNI/NIF/NIE)
More information at How to monitor and check the status of a procedure.
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Step four
Reply to the application for assessment
You will receive a decision on your application for assessment within at most two months from the date of receipt of the application.
You will receive a decision on your application for assessment within at most two months from the date of receipt of the application.
If you are asked for additional documents or information, the period for the decision will stop running and then restart once you have provided such documents or information.
If you have not been notified of the decision after two months, you can assume that your application has been accepted.
The sponsor has to notify the heads of the health service providers where the study is to be performed and give them a copy of the protocol and the documents accrediting its approval. The agreement then has to be arranged and concluded with each site where the study is to be conducted.
How do I get the reply?
You will get an e-notification. You can view the notification in the e-NOTUM service.
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Step five
Report substantial amendments
Any substantial amendment has to meet the same prerequisites for the start of the prospective follow-up observational study with medicinal products. A substantial amendment is any change which [...]
Any substantial amendment has to meet the same prerequisites for the start of the prospective follow-up observational study with medicinal products. A substantial amendment is any change which affects fundamental aspects of the study protocol, including the addition of a new publicly or privately owned site.
To report substantial amendments to the study, go to the procedure folder in your Private area, press Submit documentation at the top of the page and attach the documentation related to the amendment. You can submit as many amendments as you think necessary. The application folder can also be accessed directly from View the status of a procedure or transaction.
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Step six
Studies assessed under Order SAS/3470/2009: processing reports
There are a number of requirements in the application folder to be met in the case of studies assessed under Order SAS/3470/2009. You can log in via the documentation requirements tab of the folder [...]
There are a number of requirements in the application folder to be met in the case of studies assessed under Order SAS/3470/2009. You can log in via the documentation requirements tab of the folder in your Private area. The application folder can also be accessed directly from View the status of a procedure or transaction.
Follow-up reports
Once the study has been authorised, the sponsor has to send an annual follow-up report to the authority. To do this, go to the procedure folder (“Requirements” tab), respond to the “Annual follow-up report” request and attach the annual follow-up report for that year. Make sure that you do this from the relevant request by checking the name of the request and the deadline for submitting it.
By default there are four requests which allow four annual follow-up reports to be submitted. If the sponsor needs to submit more and there is no option for doing this, they should email the Pharmaceutical Planning and Quality Service at vigimed.salut@gencat.cat and ask for a new request to provide more documentation.
Final reportThe sponsor has to submit a final report within at most twelve months after completion of the study. To do this, go to the procedure folder (“Requirements” tab), respond to the “Final report” request and attach the final report of the study.
