Ethical and Personal Data Protection
Ethical and Personal Data Protection
ProClinica™ processes are carefully designed to assure compliance with ethical and personal data regulations. Patients (or their legal representative) are asked to complete, sign and return a “Contact Order Form” to ProClinica™. From an ethical and personal data protection perspective, this signed patient agreement provides evidence that the participant and/or his legal representative voluntarily communicated both personal and physician contact details to the ProClinica™ unit. This allows our staff to perform the patient contacts as described in the protocol during the study follow-up period.
Additionally through this form, patients are informed of their rights as required by data protection regulations.
Given that the patient has the right to refuse to answer a questionnaire or individual questions at any time and may ask to end all future contacts, it can be considered that consent to be contacted and to provide health information is tacitly renewed with each assessment.
The ProClinica™ unit never transfers patients’ nominative data to the study sponsor, monitor, or data management.
Patients’ health data are collected in a de-identified way, using a study code (e.g. patient number, site number). Contact details are never linked to the patients’ health data, and are erased at the end of the study from all data support systems (computer and paper).All interviewers working on a study sign a professional secrecy agreement, are trained specifically on the study and data privacy rules, and are supervised and quality controlled throughout the study. The medical direction of our ProClinica™ unit intervenes if necessary and patient return calls by a physician can be performed as needed.
ProClinica™ unit personnel never interfere with the care relationship between patients and healthcare professionals.
If a medical question or problem arises during a telephone call, the patient is advised to contact his/her physician.
REGISTRAT-MAPI has declared its ProClinica™ unit activities of direct contact with patients in studies and patient accompanying programs to the French Data Protection Authority (CNIL).
This declaration covers the management of patient contact details (administrative data) throughout the European Union and countries with similar data protection and when Safe Harbor agreement is available. For other countries, Data transfer agreements are processed individually according to local data privacy regulations. When health data is to be collected or transferred, the process is submitted to competent authorities for approval (e.g. ECs, data privacy boards), according to local regulations.