Küsimused

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

---

Dear Dr. Brown,

 

Thank You for Your enquiry.

 

In Estonia, we accept both the joint and separate ICF. However, we have had issues with joint ICF-s as study sponsors tend to focus heavily on the medicinal trial while leaving out imporant details about the device study in a joint ICF. In case we find that the ICF and the patient information sheet does not emphasize the device study enough and we are hesitant about whether the patient is able to understand  that they are included in not one, but two studies, we will require updates to the ICF, which will then lead to substantial modifications of the medicinal trial, new ethics committee approvals etc.

We recommend to prepare separate ICF-s as this would ease the sponsors burden in case any updates are necessary for the ICF. With separate ICF-s, the sponsor does not have to submit the document again to medicinal trial CA and the ethics committee in case the medicinal trial has already received a CA approval and a positive ethics committee opinion in case we require updates in the IVD study-s ICF. Additionally, this will ensure that the patient understands that they are included in two separate studies – a medicinal trial and an IVD performance study.

 

In case of any further questions, please do not hesitate to contact us again.

 

All the best,

 

Merili Saar-Abroi on behalf of

Department of Medical Devices

State Agency of Medicines

[email protected]

 

1 Nooruse Street

50411 Tartu

Estonia

Phone: +372 737 4140

www.ravimiamet.ee

 

 

Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada.

 

Dear Sir, Dear Madam,

 

Please forgive the unsolicited email.  I am trying to compile information for different countries under IVDR on the requirements for ICF when the study is combined IMP and IVD.

 

To date – my experience is that different countries have different requirements for the ICF:

 

•      ICF for IVD and IMP

•     ate ICF for IVD and IMP

 

In order to reduce the burden of RFIs and the workload to both Ethics Committees and the Sponsor submitting the application under IVDR/CTR I’m collating the ICF requirements.

 

Please can you advise what is the position for Estonia on ICFs for combined studies?

 

Many thanks and best wishes,

 

Dr Emma Brown