Access to Medically Assisted Reproduction and Preimplantation Diagnosis Data

Access to national MPA registry data may be requested by all MPA teams that have signed the specific data exploitation charter and provide quality data to the registry, and/or by public operators with expertise in medical data processing, commissioned by MPA teams.

By default, transmitted data will be irreversibly anonymized (not subject to authorization by the Commission Nationale Informatique et Libertés (CNIL)). Exceptionally, if the project imperatively requires identifying data, the nature of the data transmitted will depend on the project (in line with the principle of data minimization in accordance with the provisions of the French Data Protection Act of January 6, 1978) and on the applicant's obtaining authorization from the CNIL prior to sending the data. In all cases, no data enabling identification of the centers will be transmitted.

Data is transferred to selected project sponsors via a data use agreement. This agreement :

• defines the terms and conditions of secure data transfer
• defines how data will be destroyed once the study has been completed;
• restricts data use to the selected project (no reuse possible);

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

The complete file should be sent by e-mail to the following address: AOR@biomedecine.fr

The application deadlines are as follows:

• Window 1: December 06, 2021 at 5pm
• Window 2: February 07, 2022 at 5pm
• Window 3: April 11, 2022 at 5pm
• Window 4: September 12, 2022 at 5pm

Requests for extraction of data from files held by the Agence de la biomédecine are submitted during the annual filing windows defined according to the dates of the CMS meeting.

• The administrative form, signed by the person in charge and/or the coordinator of your clinical-biological center, 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.
• The title of the e-mail must be worded as follows: "NAME First name valo_AMP".
• Any e-mail containing a computer virus will be refused.
• An acknowledgement of receipt will be sent by e-mail no later than one (working) day after receipt of the submission e-mail. It is therefore advisable to send applications at least 48 hours before the deadline in order to avoid any transmission problems.

To be admissible, the application must be correctly completed and signed by the person in charge of the project.

**Applications are examined in 4 stages.**Stage 1: After the Research Department has checked that the application is admissible, it is forwarded to the CVD, which determines :

• the need for the applicant to take the necessary steps with the CNIL (administrative admissibility) ;
• the relevance of the requested variables in terms of their design and history, data entry quality and completeness (technical admissibility).

Stage 2: A written assessment is requested from three external experts: two scientific or medical specialists in the field and a methodologist. The external experts are appointed by the Agency.

Stage 3: The external assessments are forwarded to a member of the SMC, also a specialist in the field, who reports on the project to the SMC. The WSC issues an opinion, either favorable or unfavorable, as to whether or not the requested data should be made available.

Stage 4: The final decision is taken by the Director General of the Agence de la biomédecine, based on the opinion of the WSC.

• The non-confidential summaries of selected projects will then be sent to all teams that have signed the specific charter of the MPA Registry. Applicants for non-selected projects will receive a reasoned opinion including comments from the CVD, the CMS and anonymous reports from external evaluators.
• Unless specifically justified otherwise, all requests for access to data that have been selected by a national or international funding body (e.g. ANR, Europe, Agence de la biomédecine, etc.) will be exempt from stage 2.
• During step 3, projects that have been funded outside the Agence de la biomédecine's call for research proposals (i.e. not previously submitted to the CMS) will be examined by the CVD, then submitted to the CMS for its opinion.
• Once the data have been submitted, any major deviation of the study from the project selected must be submitted to the WSC for approval.

Research using national data from the Registre AMP must be published in medical and scientific journals. Any publication based on data collected in the AMP Registry must mention the Agence de la biomédecine's AMP Registry.

Before submission for publication, the project coordinator will send the manuscripts setting out the results of the research projects to the Agency, which will forward them to the CMS rapporteur, who will have 4 weeks to assess the consistency of the manuscript and its methodology with the initial project. The CMS will be informed of the rapporteur's conclusion.

Study designers and participants are signatories.

Biological or clinico-biological teams who contributed to making data available in the MPA Registry are associated with the publications via a list or a link to the list of centers inserted in the "Acknowledgments" section of the article.