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Request for access to individual data resulting from organ and tissue harvesting and transplants

Published on 31 January 2022

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CRISTAL is a computerized work tool developed by the Agence de la biomédecine and made available to all healthcare professionals involved in organ procurement and transplantation. It guarantees anonymity between donor and recipient. CRISTAL has been designed to facilitate the work of transplant professionals (doctors, surgeons, procurement coordinators, regulators, dispatchers, HLA laboratory technicians, etc.) by presenting the essential information they need.

The daily efforts of our professionals to fill CRISTAL with the utmost rigor have contributed to the creation of a valuable database. In particular, the exhaustiveness achieved on a national scale for certain variables makes this database a unique tool for conducting epidemiological studies in transplantation. In order to encourage the setting up of high-quality epidemiological studies, and to respond to transplantation professionals' requests for simplified formalities for accessing CRISTAL multi-team data, the Agence de la biomédecine is setting up a centralized system in which requests for access to data are sent to it for assessment prior to transmission of the data. Requests will be assessed for scientific and methodological relevance by recognized external experts and by the Medical and Scientific Committee, according to the procedure detailed below.

Requests for access to national data

The following may request access to data

  • all clinical teams involved in transplantation, who are signatories to the specific charter for the use of individual health data from organ and tissue harvesting and transplantation;
  • all operators with expertise in the processing of medical data, mandated by one or more clinical teams involved in transplantation, who are signatories to the specific charter for the use of individual health data from organ and tissue procurement and transplantation.

Transmitted data

The nature of the data transmitted (identifying or non-identifying data) will depend on prior CNIL approval.

  • Without CNIL authorization: anonymized national data (no possibility of going back to the identity of the person, even for the Agence de la biomédecine; no directly or indirectly identifying data).
  • With prior authorization from the CNIL justifying the use of personal data: directly or indirectly identifying national personal data.

At present, the percentage of national data, anonymized or not, accessible through this procedure is :

  • 56% for kidneys (i.e. 2000 transplants per year)
  • 100% for adult liver (i.e. 1,200 transplants per year)
  • 41% for heart (i.e. 196 transplants per year)
  • 100% for lung (380 transplants per year)

Request for files :

Project and administrative forms can be downloaded from the following links:

Submission of files

The complete application must be sent by e-mail to the following address: AOR_greffes@biomedecine.frApplications will be examined as soon as they are received:

  • The administrative form, signed by the head of department or the director of the coordinating laboratory, can be sent by fax to 01 55 93 64 51.
  • The total size of the e-mail, including attachments, must be strictly less than 10 MB.

File review

Applications are examined in 5 stages.

  • Stage 1: Evaluation of the technical admissibility of the application by a unit within the Agency (CVD: Cellule de valorisation des données).
  • Stages 2 and 3: These stages run concurrently. During stage 2, the dossiers are sent to 3 independent experts from outside the Agency, who judge the scientific and methodological relevance of the project. For stage 3, the public summaries of the projects are sent to the representatives of the teams who have signed the charter, so that they can express their reasoned refusal to share the data.
  • Step 4: Expert reports and reasoned requests for refusal to share are forwarded to the Agence de la biomédecine's Medical and Scientific Committee (CMS). The CMS will recommend whether or not to transmit the data, and will validate whether or not the data providers' reasoned requests not to share the data in CRISTAL.
  • Stage 5: the final decision on data transmission will be taken by the Agency's Director General.

Non-selected projects will receive a reasoned opinion, including comments from the DSB, the WSC and anonymous reports from external evaluators.

Results

Results will be available three months after the closing date of the submission window.

Data submission will be subject to the signature of an agreement between the Agency and the legal representative of the coordinator's institution.

Publications resulting from data use :

The signatories are the study designers and promoters. CRISTAL data providers are associated with publications via the creation of a study group when the journal accepts it. The list of names of the study group will be transmitted by the Agency (see the specific charter for details).

All publications based on data collected in CRISTAL must mention the relevant CRISTAL register of the Agence de la biomédecine.

For further information

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