By a Stopped published on April 9, 2022, the new French clinical trial agreement model (Single Congress) has been published. This new version was highly anticipated because the initial version, dating from 2016, lacked some key provisions regarding data protection compliance.
In particular, the initial project Single Congress did not take into account the qualifications of the parties from a data protection point of view. In France, investigators and sites are subcontractors and act on behalf of the sponsor, who is the data controller. This means that according to Article 28 of the GDPR, a written data processing agreement is required. However, the initial version of Single Congresspublished a few months before the GDPR, completely lacked corresponding provisions, in particular the provisions of Article 28 of the GDPR, which created some difficulties in terms of compliance.
This was also contradictory with the Unique’s Convention objective which is to simplify and accelerate the process of launching clinical trials for promoters and French health organizations by providing a simple model. The use of this model is mandatory for all research involving therapeutic acts on humans for drugs and clinical investigation for medical devices.
The new version now includes data protection provisions. It clearly refers to the relationship of data controller to subcontractor between the sites and the sponsor (article 11 bis) and includes an appendix 3 containing the mandatory provisions of article 28 of the GDPR and a list of the security measures that must be implemented by the subcontractor.
This annex 3 is however disappointing because the provisions of the data processing agreement it contains are very basic, mainly repeating the provisions of the GDPR without taking into account a certain number of specificities essential to the operational requirements of data processing. in clinical trials. .
For example, it briefly discusses pseudonymization as a possible security measure, but it does not include the provision of encrypted data to the sponsor which is an essential element in this area. Furthermore, it does not provide for the fairly common case where the sponsor is located outside the EU, which requires additional provisions regarding the protection of data transfers.
From a regulatory point of view, the Single Congress does not bring much novelty, so it does not meet the rigid framework in which clinical trial agreements are concluded in France. French regulations prohibit entering into any paid service agreement with trial sites or investigators in addition to the Single Congressand the Single Congress is not meant to be modified. The starting position with the test sites was therefore to use a Single Congress and refrain from providing any valuable consideration other than what is contemplated under the Single Congress.
However, experience shows that contracting practices do not always strictly follow this approach and some changes are implemented from time to time, for various reasons related to the increased complexity of some clinical trials. This includes (i) ensuring that specific agreements for the exchange of safety or quality data are concluded for particularly sensitive test products, (ii) taking into account the specific conditions arising from the use of digital tools in the tests, (iii) to implement additional contracts required by specific procedures not taken into account by the Single Congress (e.g. related testing or diagnostic services, or apheresis procedures for gene therapies, which are needed in practice but not contemplated by the Single Congress and its pricing schedules), or (iv) articulation with development involving companion products in which medical devices and drugs are developed in parallel.
This new version is immediately applicable to clinical trial agreements entered into on or after April 10, 2022, and there is no transition period. It is also clearly stated, under Article 12 of the Single Congressthat electronic signature processes can be used, which helps to speed up the signing process.
In practice, pharmaceutical laboratories and medical device manufacturers’ clinical teams must now understand and train in this new version to ensure that it is used correctly.
In terms of contractual negotiations between investigators and/or sites with sponsors, we expect, however, that discussions will still be necessary to conclude additional contractual commitments, without valid consideration as this will be prohibited. These additional commitments will still be needed to (i) improve the framework for data processing activities, including the enforcement of EU standard contractual clauses to enable data transfers outside the EU will be needed in many cases, and (ii) meet other requirements arising from the increased sophistication of testing.