Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/10152-1 |
| Registreeritud | 09.10.2024 |
| Sünkroonitud | 10.10.2024 |
| Liik | Sissetulev 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: Tanvi Kaushal <[email protected]>
Sent: Mon, 02 Sep 2024 11:14:18 +0000
To: [email protected]
Cc: Apurva Kushare <[email protected]>
Subject: 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 |
|---|---|---|---|---|---|---|
| Vastuskiri | 09.10.2024 | 1 | 11.2-1/24/10152-2 | Väljaminev dokument | ta | Regdesk |