In some cases, mediSMART may act as data controller under applicable local regulations and data protection laws. mediSMART takes all necessary measurements regarding protection of personal data when acting as data controller
What we mean by Personal Information is the information which may be capable of identifying the individual such as research investigators or our clients, vendors we work with. Personal information may include, but not limited to, date of birth, e-mail address, name and surname, company information and medical information. You may be requested to provide Personal Information while visiting our web site. If you are a research subject, with your consent, information regarding your medical history and/or laboratory test results may be collected. These information may be transferred to a client which is the sponsor of clinical research you participate, under research protocol and applicable data protection laws. Information collected from you will be replaced with a code which will not enable your Personal Information to be identified.
In some cases, we may request you to provide information via surveys. Participation such surveys is completely voluntary. You may prefer not to provide information via such surveys.
mediSMART does not collect any data about you without your permission. To be able to collect any Personal Information from a clinical research volunteer, an Informed Consent Form must be obtained from volunteer by Institution and/or organization performing the research. The Informed Consent Form must be approved by mediSMART and study sponsor as well as the Ethics Committee and Regulatory Agency giving the positive opinion regarding the initiation of the clinical research in the country. The Informed Consent Form will include Personal Information of volunteer such as name and surname, home address, contact information. The Informed Consent will also include information regarding data protection and permission for use/disclosure of data and access to medical records by study sponsor for data analysis and marketing approval purposes.
All data will be behaved as confidential and will be in a format which will not identify the Personal Information directly.
Unless required by applicable local regulations and law, all collected and processed data will not be publicity available. Only institutions and/or organizations performing the research, study sponsor and authorized mediSMART employee working on behalf of sponsor will be able to access the personal data for research purposes.
All collected information is used to carry out clinical researches and to support research volunteers. When required, data may be available for following authorities:
Regulatory agencies as required by law;
Health authorities as required by law;
Authorized sponsor representatives involving in clinical researches.
You may contact us at mediSMART Ltd. Cinnah Cad. 12/1 06680 Kavaklidere Cankaya Ankara Turkey, email@example.com, if you:
Want to get information regarding accuracy of collected data about you.
Want to update or modify Personal Information collected from you.
Have any concern or complaint regarding collection and/or use of collected Personal Information.
When requested, we will make necessary changes/modifications on any information you have provided to us via our web site.
Research volunteers and/or their legal representatives have also right to request their Personal Information from research institutions and/or organizations via treating physicians as well as reviewing and making modifications on their Personal Information. You can directly notify research institution and/or organization via treating physicians when you have such request to review and/or correct your Personal Information.
When you desire your Personal Information not be collected and used for research purposes any more, you have right to withdraw your consent any time during the clinical research without having any rationale. When you withdraw your consent, no further Personal Information about you can be collected and processed. However Personal Information collected from you till the date you withdraw your consent, may be used and processed to protect wellbeing of you and integrity of the clinical research.
All data provided to mediSMART is kept in a form which does not contain Personal Information directly. In addition mediSMART takes following precautions to apply high security levels:
mediSMART employees/staff work under company confidentiality policies are aware their responsibilities when handling data.
mediSMART archiving facilities where hard copy filings are performed have restricted access.
Regarding computer security, multi-level protection solutions such as firewalls, password protections are in place.
mediSMART network is protected for unauthorized accesses.
Regular performance testing of network is performed to ensure continuity.
All archived materials and data are kept for research purposes and until the time they are not required for business under applicable local regulations and guidelines.
All mediSMART employees/workers involving in clinical research should comply with mediSMART policies and procedures. Any breach of such confidentiality and procedures are subject to disciplinary action.
If in any case, mediSMART merges with another company or sells some or all parts of its assets or is acquired by another company or transfers all its obligations to another organization/company under certain circumstances, we are entitled to share all information and data provided to us through business or merger partners.