Selgitustaotlus

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[email protected]

experts-recherche-lymphome.org/lysarc I lymphoma-research-experts.org/lysarc

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