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Selgitustaotlus

Andmekaitse Inspektsioon · 4. aprill 2025
Viit
2.2-9/25/1071-1
Registreeritud
4. aprill 2025
Dokumendi liik
Sissetulev kiri
Adressaat
LYSARC Centre Hospitalier Lyon-Sud
Saabumis/saatmisviis
e-post
Funktsioon
2.2 Loa- ja teavitamismenetlused
Sari
2.2-9 Selgitustaotlused
Toimik
2.2-9/2025
Vastutaja
Liina Kroonberg (Andmekaitse Inspektsioon, Koostöö valdkond, Koolitus- ja ennetustiim)
Lahendamise tähtaeg
19. aprill 2025

Failid

Sisu (failidest)

Saatja: "Ombeline Verite" <[email protected]> Saaja: "AKI info" Teema: Request for information regarding the reuse of clinical research data / Estonia Kuupäev: 2025-04-04 07:52 Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. Dear Sir/Madam, My name is Ombeline Vérité, and I am a Regulatory Affairs officer at LYSARC. As part of our clinical research, we have accumulated a large number of data, biological samples, and medical images. All patients who participated in these clinical studies signed an informed consent form that mentions the possibility of secondary use of their data and samples for research on lymphoma. All data is pseudonymized. We intend to reuse this data in order to continue our research and contribute to the advancement of knowledge about lymphoma. While we are well familiar with the procedures in place in France, we would like to learn more about the specific regulations in your country regarding the reuse of pseudonymized clinical research data. In this regard, could you kindly clarify the following points: 1. In France, we have a reference methodology. If we commit to following it, we can reuse the data under certain circumstances. Is there a similar mechanism in your country? 2. What steps must be followed before we can reuse the data, biological samples, and medical images? 3. What administrative procedures should we undertake, and what are the associated modalities? If you are unable to answer these questions, we would appreciate it if you could direct us to the relevant person or institution who could provide this information. Thank you in advance for your attention to this request, and I remain at your disposal for any further information. Yours sincerely, Ombeline Vérité Chargée d’affaires réglementaires Regulatory affairs officer LYSARC Centre Hospitalier Lyon-Sud Bâtiment 2D - 69495 PIERRE-BÉNITE Cedex FRANCE Direct : +33 (0) 4-27-01-27-61 <mailto:[email protected]> [email protected] <https://experts-recherche-lymphome.org/lysarc/> experts-recherche-lymphome.org/lysarc I <https://lymphoma-research-experts.org/lysarc/> lymphoma-research-experts.org/lysarc <https://www.linkedin.com/company/lysarc> Absence à venir : tous les après midi Forthcoming absence : every afternoon ( <https://experts-recherche-lymphome.org/actualites/?group=lysarc> Retrouvez toutes nos dernières actualités
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