The MR-001, what is it and how to respect it?

As CRA, we are concerned with the application of the MR-001 or Reference Methodology. The MR-001 is a procedure used to simplify the reporting of data processing, in clinical trials, to the National Commission for Data Protection and Liberties (CNIL). Here we will explain what studies are involved and how to respect the MR001? Here are some answers.

The MR-001 is used to group in a single file, the statement of data processing, for all the tests performed by a promoter. Thanks to this simplified procedure, you will have a regulatory submission in less to achieve since you will not have to make a complete submission to the CNIL even CCTIRS (this is already something gained 😉 ). Your promoter will simply ensure that he agrees with the said methodology and provide proof in case of CNIL inspection.

1. Who is concerned?

• Non-interventional researches: Not concerned
• Researches to evaluate the routine care: Not concerned 
• Biomedical research: They are concerned with the MR-001 BUT these trials must meet a number of criteria to comply with this methodology. 
  There is no restriction to the purpose of the study. Your trial may cover a drug, medical device, cosmetic or tattoo or be out of health products.
• The Temporary Recommendations for Use (TRU) and Temporary Authorizations of Use (TAU). Not concerned.
  However, since January 2015, the TRU and TAU also have a unique authorization: The unique authorization AU-041. For more information, you can visit the CNIL website here.

Practically in your CRA work: As CRA, in charge of regulatory submissions, you have to ensure that the study complies with the MR-001. If the study is consistent with the MR-001, make sure that the promoter has already provided a commitment complying with the MR-001 to the CNIL . This commitment applies to all studies conducted by the promoter.
Otherwise, the promoter will have to go on the CNIL website to achieve this compliance commitment. Tell it to your project manager or to your promoter!

2. How to respect it?

The MR-001 covers several aspects of the trial:

• Information of patients on the fate of their data,
• Information of investigators and other research participants (pharmacist, CET, radiologists…) on the fate of their data (especially when you collect their CVs)
• The collection of the patient’s consent,
• The data collected,
• Data processing,
• Data analysis,
• People with access to data,
• Conversations duration,
•  Treatment Security,
• The data transfer abroad.

Here are some points with which you should pay attention.

• Particular data: ethnicity and race, sex life, genetic data

Often international promoters require the collection of the patients ethnicity data. Indeed, it has been shown that certain groups of the population respond more or less well to treatment based on their ethnicity.

However, according to the Data Protection Act of 6 January 1978 in France:
“It is forbidden to collect or process personal data that reveal, directly or indirectly, poeple racial or ethnic origins, political, philosophical or religious opinions or trade union membership, or which relate to the health or sexual life of these. ”

However, the said Act and the MR-001 allow the collection of such data if they are relevant in the light of the research.

Thus, the promoter may collect ethnicity or race data concerning sex life or genetic changes in patients. However, such data collection objectif must be specified in the study protocol and the patient must give his informed consent for the collection of such data.

Practically in your CRA work: Upon regulatory submission to the CPP (Institutional Review Board), I advise you to read your CRF. If you notice that this type of data is requested, tell this to the study promoter or with your project manager: does he have a scientific reason to collect this data? If so, ask him to state it clearly in the protocol or prepare a letter clarifying that information for your submission to the Ethics Committee (otherwise. The Ethics Committee may ask you this later). If the collection of such data is not justified, this information cannot be collected in France and the center will not have the right to complete this field in the CRF. So you will have to look after it.

• The information note and informed consent form

Patients should be informed and give their informed consent to participate in biomedical research. The information given by the investigator to the patient must be summarized in the information note given to the patient. The MR-001 also advocates to state on the information note everything concerning the processing of patients personal data.

In practice in your CRA work: you must indicate in your informed consent: the nature of the transmitted data (e.g.: ethnicity, sex life …), the purpose of the data processing, natural or legal persons recipients of the data (the promoter, the Competent Authorities, …), the existence of the access right, rectification, and opposition, the possible inclusion in the national register of the person participating in the research (in case of research on healthy volunteers or patients with pathology unrelated to the product studied), … You will find ready-made phrases in the MR-001, you will simply adapt them to your study and that’s it 😉

Beware, if your study requires the collection and processing of genetic data, a specific consent must be obtained from the patient.

• Data from other participants in the research (investigators, CET…)

Research participants data are anonymous. However, the data that is collected for other participants (investigators, CET, Pharmacist…) are generally registered (especially when you collect CVs).

Practically in your CRA work: Other participants must then also be informed of the processing of their personal data. This information should be on:

– The agreement signed with the investigator or,

– A document given to investigators and others participants that will preferably be signed by the concerned person.

• In case of data transfer abroad

In case of international study, data about your patients, investigators and others will not stay in France. These data will probably be transferred to companies located in other countries in Europe or countries out of the European Union. Beware, the transfer I am speaking to here, concerns any company through which the data passes by: it can be your promoter, but also a subcontractor for data entry, for example.

The identified data transfer of your patients is allowed. However, the patient should be informed of the data transfer outside the European Union in his Informed consent.
However, you should know that the transfer of personal data identifiers outside the EU are prohibited (This applies to data included in the CV of your investigators and other professionals, for example). Except in the following case:

• If the data transfer takes place to a country considered as”providing an adequate level of data protection.” You will find an interactive map on the website of the CNIL here.

• If standard contractual clauses were signed between the two companies (a company in France and a subcontractor abroad for example). This is a contract signed by the two companies that fixes the responsibilities of every part. The contract must be approved by the European Commission. You can find a standard contract here.

• If your promoter adopted Internal Corporate Rules (Biding Corporate Rules BCR). This is a code of conduct in data transfer matters abroad adopted within a group (your promoter and his subsidiaries).

In your CRA work: You have to check if your promoter has adopted one of these measures. In this case, it is not necessary to make an application to the CNIL. Otherwise, you will have to make one for the transfer of such data or suggest any of these solutions to the promoter (Safe Harbor, Contractual Clauses Types, and BCR).

Beware, if your sponsor is not based in the EU, he must appoint a legal representative established in the European Community under Article  L1121-1 of the Code of Public Health. This legal representative must respect the French regulation.
TO sum up, the data of the persons ready for the research and other participants (investigators, CET, Pharmacists) must be protected both during data processing, and during their transfer or archiving. Individuals must be informed of the processing of their data and must consent to this processing, either on a contract or on a specific document explaining the fate of their data.

I hope this little abrigement could enlighten you on the MR-001.

For more information, you can visit the website below:

• For the conformity declaration with the MR-001: http://www.cnil.fr/vos-obligations/declarer-a-la-cnil/

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