Vastuskiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/10152-2 |
| Registreeritud | 09.10.2024 |
| Sünkroonitud | 10.10.2024 |
| Liik | Väljaminev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-1 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus) |
| Toimik | 11.2-1/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Regdesk |
| Saabumis/saatmisviis | Regdesk |
| Vastutaja | Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Meditsiiniseadmed (Medical Devices)" <[email protected]>
Sent: Wed, 04 Sep 2024 07:32:27 +0000
To: 'Tanvi Kaushal' <[email protected]>
Cc: Apurva Kushare <[email protected]>
Subject: Vs: Enquiry regarding Electronic Clinical Trial document submissions
Dear Tanvi
Thank You for Your inquiry.
Please note that the Health Board is only competent to answer the questions in the scope of medical devices. In case You are interested in any information related to medical device clinical investigation/performance studies, please let us know.
In case these questions are strictly asked in the scope of the drug trial (excluding any and all aspects of a possible the medical device investigation), please contact our colleagues from the Estonain Medicines Agency via [email protected]
All the best,
Merili Saar-Abroi
Chief Specialist
Department of Medical Devices
Phone +372 554 3041
[email protected] | [email protected]
| Terviseamet | Health Board +372 794 3500 [email protected] Paldiski mnt 81, 10614 Tallinn |
This e-mail is confidential and meant for use by the person named in the letterhead. Any use in any way or copying of it by a person not marked as the addressee thereof is prohibited. If you have got this e-mail by mistake, please notify of it the sender without delay and delete the received e-mail together with all its attachments.
Saatja: Tanvi Kaushal <[email protected]>
Saatmisaeg: esmaspäev, 2. september 2024 14:14
Adressaat: Meditsiiniseadmed (Medical Devices) <[email protected]>
Koopia: Apurva Kushare <[email protected]>
Teema: Enquiry regarding Electronic Clinical Trial document submissions
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sir/Madam,
We are a US-based regulatory software company. Our client is a USA-based medical device manufacturer that has a product that is used in a drug clinical trial.
They are seeking to obtain specific information on electronic provisions for drug clinical trial document submissions for their product. Therefore, it should be clinical trial information for drugs. Could you help us answer the following questions regarding the DRUG clinical trial in YES/NO format?
1. Is electronic Informed Consent accepted?
2. Is electronic Clinical Outcome Assessment accepted?
3. Is electronic Patient Reported Outcomes accepted?
4. Is there a provision for a Tele-visit? (Video conferencing between HCP and patient)?
Please support your answers with relevant laws/guidance documents
Thanks and Regards
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 09.10.2024 | 1 | 11.2-1/24/10152-1 | Sissetulev dokument | ta | Regdesk |