Common use of Medical confidentiality, data protection and data controlling Clause in Contracts

Medical confidentiality, data protection and data controlling. In line with the current position of the CCMO, the Study Site and Sponsor are considered joint controllers for the processing of the Personal Data and will both handle all Personal Data in accordance with the GDPR and any other to the performance of the Clinical Study applicable laws or regulations covering the protection of Personal Data (collectively “Data Protection Law”). Parties, will fully cooperate with each other as joint controllers and shall take the necessary measures in order to comply with the Data Protection Law, such cooperation shall duly reflect the respective roles and relationships of the joint controllers vis-à-vis the Clinical Study Subjects as data subjects, in particular as regards the exercising of the rights of these data subjects and the Parties’ respective duties to provide the information referred to in Articles 13 and 14 of the GDPR. Each joint controller shall maintain a record of processing activities under its responsibility. In the event law and interpretation by the CCMO and/or a relevant data protection authority or a court decision should prescribe or indicate another qualification of the roles of the parties in clinical trial agreements, the Parties hereto shall consult with each other and shall adapt the qualification of their roles and change arrangements as may be deemed appropriate. Each Party shall be responsible for its own processing of Personal Data in accordance with all Data Protection Law and with the ICFs obtained from Clinical Study Subjects and to the extent applicable, Personal Data consents obtained from the Site Investigator and Research Staff. Both Sponsor and Study Site shall implement appropriate technical and organizational measures to meet the requirements of the GDPR. If any Party becomes aware of a Personal Data breach in connection with this Clinical Study or the performance of this Agreement, that Party shall promptly notify the other Party/-ies, and, the Party that is the controller of the relevant Personal Data shall also document the Personal Data breach and report the breach to the applicable regulatory authorities. In such case, Parties will fully cooperate with each other in order to fulfil the (statutory) notification obligations timely. A Personal Data breach refers to: a personal data breach as defined in article 4 paragraph 12 GDPR and further determined by articles 33 and 34 of the GDPR. Each Party agrees to co-operate with any competent supervisory authority and to allow such supervisory authority to audit each Party’s compliance with the GDPR. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Study Subjects. Sponsor shall provide an Ethics Committee approved ICF to Site Parties. Sponsor acknowledges that Clinical Study Subjects – and/or their legal representatives on their behalf – may withdraw, in whole or in part, their initial informed consent. Site Investigator shall promptly notify Sponsor of any such withdrawal of the informed consent of a Clinical Study Subject, which may affect the use of such Clinical Study Subject’s Personal Data under this Agreement. The Site Investigator will communicate with Sponsor on behalf of the Clinical Study Subject. However, the procedure followed upon such withdrawal of a Clinical Study Subject’s consent will be according to the instructions, to the extent laid down in the Protocol and the ICF, and in accordance with the Aplicable(Data Protection) Law. Sponsor shall refrain from tracing and/or identifying any Clinical Study Subject, except where Sponsor is under a legal obligation to do so. In the event any Clinical Study Subject, for any other than aforementioned reason, becomes identifiable to Sponsor, Xxxxxxx agrees to preserve, at all times, the confidentiality of information pertaining to such Clinical Study Subjects. Site Investigator’s (and Research Staff’s) personal information Where applicable, Sponsor shall inform the Site Investigator, and to the extent applicable other Research Staff involved in the Clinical Study as well, of the collection, the use and the transfer of his/her/their Personal Data and his/her/their rights in respect of such processing as set forth in articles 13 and 14 GDPR, as well as the essence of the arrangement between the Parties as joint controllers referred to in article 26 paragraph 1 GDPR. Site Parties agree to help Sponsor obtain any express consents, as may be necessary in accordance with applicable Data Protection Law from the Site Investigator, and to the extent applicable and necessary from other Research Staff involved in the Clinical Study as well, for any intended processing of his/her/their Personal Data by Sponsor.

Medical confidentiality, data protection and data controlling. In line with the current position of the CCMO, the The Study Site and Sponsor are considered joint controllers for the processing of the Personal Data and will both handle all Personal Data in accordance with the GDPR and any other to the performance of the Clinical Study applicable laws or regulations covering the protection of Personal Data (collectively “Data Protection Law”). Parties, will fully cooperate with each other as joint controllers and shall take the necessary measures in order to comply with the Data Protection Law, such cooperation shall duly reflect the respective roles and relationships of the joint controllers vis-à-vis the Clinical Study Subjects as data subjects, in particular as regards the exercising of the rights of these data subjects and the Parties’ respective duties to provide the information referred to in Articles 13 and 14 of the GDPR. Each joint controller shall maintain a record of processing activities under its responsibility. In the event law and interpretation by the CCMO and/or a relevant data protection authority or a court decision should prescribe or indicate another qualification of the roles of the parties in clinical trial agreements, the Parties hereto shall consult with each other and shall adapt the qualification of their roles and change arrangements as may be deemed appropriate. Each Party shall be responsible for its own processing of Personal Data in accordance with all Data Protection Law and with the ICFs obtained from Clinical Study Subjects and to the extent applicable, Personal Data consents obtained from the Site Investigator and Research Staff. Both Sponsor and Study Site shall implement appropriate technical and organizational measures to meet the requirements of the GDPR. If any Party becomes aware of a Personal Data breach in connection with this Clinical Study or the performance of this Agreement, that Party shall promptly notify the other Party/-ies, and, the Party that is the controller of the relevant Personal Data shall also document the Personal Data breach and report the breach to the applicable regulatory authorities. In such case, Parties will fully cooperate with each other in order to fulfil the (statutory) notification obligations timely. A Personal Data breach refers to: a personal data breach as defined in article 4 paragraph 12 GDPR and further determined by articles 33 and 34 of the GDPR. Each Party agrees to co-operate with any competent supervisory authority and to allow such supervisory authority to audit each Party’s compliance with the GDPR. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Study Subjects. Sponsor shall provide an Ethics Committee IRB approved (if applicable) ICF to Site Parties. Sponsor acknowledges that Clinical Study Subjects – and/or their legal representatives on their behalf – may withdraw, in whole or in part, their initial informed consent. Site Investigator shall promptly notify Sponsor of any such withdrawal of the informed consent of a Clinical Study Subject, which may affect the use of such Clinical Study Subject’s Personal Data under this Agreement. The Site Investigator will communicate with Sponsor on behalf of the Clinical Study Subject. However, the procedure followed upon such withdrawal of a Clinical Study Subject’s consent will be according to the instructions, to the extent laid down in the Protocol and the ICF, and in accordance with the Aplicable(Data Applicable (Data Protection) Law. Sponsor shall refrain from tracing and/or identifying any Clinical Study Subject, except where Sponsor is under a legal obligation to do so. In the event any Clinical Study Subject, for any other than aforementioned reason, becomes identifiable to Sponsor, Xxxxxxx agrees to preserve, at all times, the confidentiality of information pertaining to such Clinical Study Subjects. Site Investigator’s (and Research Staff’s) personal information Where applicable, Sponsor shall inform the Site Investigator, and to the extent applicable other Research Staff involved in the Clinical Study as well, of the collection, the use and the transfer of his/her/their Personal Data and his/her/their rights in respect of such processing as set forth in articles 13 and 14 GDPR, as well as the essence of the arrangement between the Parties as joint controllers referred to in article 26 paragraph 1 GDPR. Site Parties agree to help Sponsor obtain any express consents, as may be necessary in accordance with applicable Data Protection Law from the Site Investigator, and to the extent applicable and necessary from other Research Staff involved in the Clinical Study as well, for any intended processing of his/her/their Personal Data by Sponsor.

Medical confidentiality, data protection and data controlling. In line with the current position of the CCMO, the Study Site and Sponsor are considered joint controllers for the processing of the Personal Data and will both handle all Personal Data in accordance with the GDPR and any other to the performance of the Clinical Study applicable laws or regulations covering the protection of Personal Data (collectively “Data Protection Law”). Parties, as joint controllers, will fully cooperate with each other as joint controllers and shall take the necessary measures in order to comply with the Data Protection Law, such cooperation shall duly reflect the respective roles and relationships of the joint controllers vis-à-vis the Clinical Study Subjects as data subjects, in particular as regards the exercising of the rights of these data subjects and the Parties’ respective duties to provide the information referred to in Articles 13 and 14 of the GDPR. Each joint controller shall maintain a record of processing activities under its responsibility. In the event law and interpretation by the CCMO and/or a relevant data protection authority or a court decision should prescribe or indicate another qualification of the roles of the parties in clinical trial agreements, the Parties hereto shall consult with each other and shall adapt the qualification of their roles and change arrangements as may be deemed appropriate. Each Party shall be responsible for its own processing of Personal Data in accordance with all Data Protection Law and with the ICFs obtained from Clinical Study Subjects and to the extent applicable, Personal Data consents obtained from the Site Investigator and Research Staff. Both Sponsor and Study Site shall implement appropriate technical and organizational measures to meet the requirements of the GDPR. If any Party becomes aware of a Personal Data breach in connection with this Clinical Study or the performance of this Agreementbreach, that Party shall promptly notify the other Party/-ies, and, the Party that is the controller of the relevant Personal Data shall also document the Personal Data breach and report the breach to the applicable regulatory authorities. In such case, Parties will fully cooperate with each other in order to fulfil the (statutory) notification obligations timely. A Personal Data breach refers to: a personal data breach as defined in article 4 paragraph 12 GDPR and further determined by articles 33 and 34 of the GDPR. Each Party agrees to co-operate with any competent supervisory authority and to allow such supervisory authority to audit each Party’s compliance with the GDPR. The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Study Subjects. Sponsor shall provide an Ethics Committee approved ICF to Site Parties. Sponsor acknowledges that Clinical Study Subjects – and/or their legal representatives on their behalf – may withdraw, in whole or in part, their initial informed consent. Site Investigator shall promptly notify Sponsor of any such withdrawal of the informed consent of a Clinical Study Subject, which may affect the use of such Clinical Study Subject’s Personal Data under this Agreement. The Site Investigator will communicate with Sponsor on behalf of the Clinical Study Subject. However, the procedure followed upon such withdrawal of a Clinical Study Subject’s consent will be according to the instructions, to the extent laid down in the Protocol and the ICF, and in accordance with the Aplicable(Data (Data Protection) Law. Sponsor shall refrain from tracing and/or identifying any Clinical Study Subject, except where Sponsor is under a legal obligation to do so. In the event any Clinical Study Subject, for any other than aforementioned reason, becomes identifiable to Sponsor, Xxxxxxx agrees to preserve, at all times, the confidentiality of information pertaining to such Clinical Study Subjects. Site Investigator’s (and Research Staff’s) personal information Where applicable, Sponsor shall inform the Site Investigator, and to the extent applicable other Research Staff involved in the Clinical Study as well, of the collection, the use and the transfer of his/her/their Personal Data and his/her/their rights in respect of such processing as set forth in articles 13 and 14 GDPR, as well as the essence of the arrangement between the Parties as joint controllers referred to in article 26 paragraph 1 GDPR. Site Parties agree to help Sponsor obtain any express consents, as may be necessary in accordance with applicable Data Protection Law from the Site Investigator, and to the extent applicable and necessary from other Research Staff involved in the Clinical Study as well, for any intended processing of his/her/their Personal Data by Sponsor.