GDPR

Clinical research Consultants abides by the
General Data Protection Regulation 2016/679.

As concerns data pertaining to subjects involved in clinical trials, Clinical research
Consultants only processes and maintains pseudonymised data that are in no case identifiable.
Clinical research Consultants does not issue any Newsletters or initiate/maintain wide scale
email contacts without a specific purpose and with the assent of recepients.
Clinical research Consultants does not directly perform Data Management, Data Processing or
Statistical Analysis of health-related data, and as such does not develop or maintain any such
databases. Access to Sponsor-managed databases is under the full responsibility of the said
Sponsor.
Clinical research Consultants will ensure during contractual processes and to the best of its
efforts, that personal Data Management and Processing performed by the Sponsors or third
party subcontractors is in accordance with GDPR. Particular scrutiny will be exercised as to the
nomination by such third parties of a Data Protection Officer, a Controller or Processor as
applicable, to the performance of adequate Data Protection Impact Assessments and to transfers
of personal data to third countries or international organisations. Clinical research Consultants
cannot substitute itself to such third party obligations but will ensure its obligations of means to
enforce the requirements.

As a general rule, concerning any personal data filed into Clinical research Consultants systems,
the following rules are applied :

  • Personal data are processed in a lawful and transparent manner, ensuring fairness
    towards the individuals whose personal data are processed.
  • The specific purposes for processing the data are clearly indicated to study subjects
    prior to collecting their personal data through a comprehensive information and consent
    process validated by a competent Ethics Committee.
  • Only the personal data that is necessary to fulfil this specific purpose is collected.
  • Personal data accuracy and up-to-dateness is maintained, with identifiable processes
    to correct it including the right to access and correct data by concerned individuals and
    study subjects.
  • Further use the personal data for other purposes that aren’t compatible with the
    original purpose of collection is banned.
  • Personal data is not stored for longer periods than necessary for the purposes for
    which it was collected.
  • Appropriate technical and organisational safeguards are enforced that ensure the
    security of the personal data, including protection against unauthorised or unlawful
    processing and against accidental loss, destruction or damage.

Study-related information, including among others pseudonymised patient data, staff,
subcontractors and physician CVs, training records, payment information, company and
employment records and any other pertinent information are maintained for 15 years after the
end of a specific study in accordance with the longest-term data conservation requirements in
relevant European country clinical study legislations.

Should any concerned party wish to access, erase or modify his/her personal data, they are hereby requested to contact

Myra Daridan at Clinical research Consultants to voice such requests indicating in the title zone of the email « GDPR request »

http://www.clinicalres.com/about-us/contact/

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Agence de communcation B.carré

Clinical Research Consultants offers management and flexibility in the conduct of clinical trials in many countries. Local reulatory knowledge and experience are ensured thanks to the locally based monitors/CRA.