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Datasets Access: 3- Ethical & legal advising

Virtual
Pricing/Discount Options: Call #2
Unique Identifier: 5065934e-0660-456a-bc58-938bd6e8c05f

Service Description

This service focuses on providing support in analyzing the legal and ethical framework, which involves helping to understand the laws and regulations in force, as well as the ethical principles and values applicable for clinical data warehouse exploitation. It may involve compliance assessment, particularly with regard to RNIPH and legal compliance, which consists in ensuring that the activities in question comply with the applicable laws and rules. It may include assistance with the construction and filing of regulatory dossiers with French regulatory authorities*. It offers the opportunity to have several documents reviewed and evaluated by experts as some help for deposit. This service is tailored by the SME needs.​

Details:​     An initial consultation meeting with a legal expert of the hospital to clarify the requirements for the regulatory submissions.​     One feedback session and an annotated report for each document (study protocol, data protection impact assessment GDPR, etc.) that the SME needs to revise are included. New submission will result in a re-evaluation of the service charges.

Prerequisite : our service Feasability study must have been previously conducted.

Method Description: Depending on the SME needs and available ressources, this service may include all or part of the following task list:     Analysis of legal and ethical framework by our Institutional Review Board (IRB) [optional]     Compliance assessment (Category of research, legal compliance, etc.) [optional]     Assistance and advice on building regulatory files [optional]

Method reference: Local method respecting General Data Protection Regulation (GDPR), *French regulatory autorities :

Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé (CESREES),     Commission Nationale de l’Informatique et des Libertés (CNIL), MR-004 reference methodology requirements and EU regulations 2017/745 and 2020/561 on medical devices

Offerings: Ethics & Regulatory Affairs Expert Medical Opinion
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Provider & Contact

Provider Country France
Published Email tef-health@chu-grenoble.fr

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Our service "Feasability study" must have been previously conducted.
Dependencies & Restrictions MDR;GDPR;AI Act
Service Standards     EU regulations 2017/745 and 2020/561 on medical devices     MR-004 reference methodology [French]     Commission Nationale de l’Informatique et des Libertés  [French]     Comité d’Expertise pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé  [French]     General Data Protection Regulation
  • Comité d’Expertise pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé [French]
  • Commission Nationale de l’Informatique et des Libertés [French]
  • EU regulations 2017/745 and 2020/561 on medical devices
  • General Data Protection Regulation
  • MR-004 Reference Methodology