Personal Data of Study Subjects Sample Clauses
Personal Data of Study Subjects. Pfizer will be an independent Controller with respect to its Processing of Personal Data contained in the Study Data that are reported by Institution or Principal Investigator to Pfizer or otherwise created by Pfizer. Institution or Principal Investigator is the Controller of Personal Data Processed by Institution with respect to the medical treatment of the StudySubject.
Personal Data of Study Subjects. Pfizer shall be an independent Controller with respect to its Processing of Personal Data contained in the Study data that is reported by Health Services Provider to Pfizer or CRO. Health Services Provider shall continue to be an independent Controller of Personal Data Processed by Health Services Provider with respect to the treatment of the Study subject pursuant to medical standard of care and applicable legal obligations. Health Services Provider agrees to obtain from each Study subject, prior to that individual’s participation in the Study, a signed informed consent, approved in writing by Pfizer or CRO and by any applicable ethics committee, and which shall include the necessary content to allow for the Processing of the Study subject’s Personal Data for the purposes described in the Study protocol and the Agreement.
Personal Data of Study Subjects. Pfizer shall be an independent Controller with respect to its Processing of Personal Data contained in the Study data that is reported by Institution to Pfizer or Covance. Institution shall continue to be an independent Controller of Personal Data Processed by Institution with respect to the treatment of the Study subject pursuant to medical standard of care and applicable legal obligations. Institution agrees to obtain from each Study subject, prior to that individual’s participation in the Study, a signed informed consent, approved in writing by Pfizer or Covance and by any applicable ethics committee, and which shall include the necessary content to allow for the Processing of the Study subject’s Personal Data for the purposes described in the Study protocol and the Agreement.
Personal Data of Study Subjects. Sponsor shall be an independent Controller with respect to its Processing of Personal Data contained in the Study data that is reported by Institution to Sponsor or Covance. Institution shall continue to be an independent Controller of Personal Data Processed by Institution with respect to the treatment of the Study subject pursuant to medical standard of care and applicable legal obligations. Institution agrees to obtain from each Study subject, prior to that individual’s participation in the Study, a signed informed consent, approved in writing by Sponsor or Covance and by any applicable ethics committee, and which shall include the necessary content to allow for the Processing of the Study subject’s Personal Data for the purposes described in the Study protocol and the Agreement.
Personal Data of Study Subjects. Parties acknowledge that Pfizer shall act as an independent Controller with respect to its Processing of coded Personal Data of Study Subjects obtained in accordance with Informed consent form, and with respect to Personal Data of Investigator and Institution's employees obtained in accordance with Agreement that is reported by Institution to Pfizer or CRO. Institution shall act as an independent Controller of any medical records obtained by Investigator from Study Subjects and any other Personal Data gathered or generated by Investigator in the course of the Study for the purposes of conducting his independent medical judgment in accordance with the Protocol and with respect to the treatment of the Study subject pursuant to medical standard of care and applicable legal obligations. The Parties and Pfizer acknowledge that the Investigator shall obtain from each Study subject, prior to that individual’s participation in the Study, a signed informed consent, approved in writing by Pfizer or CRO and by any applicable ethics committee, and which shall include the necessary content to allow for the Processing of the Study subject’s Personal Data for the purposes described in the Study protocol and the Agreement.
Personal Data of Study Subjects. XXX will be an independent Controller with respect to its Processing of Personal Data contained in the Study Data and Biological Samples that are reported by Institution or Principal Investigator to XXX or otherwise created by XXX. Institution or Principal Investigator is the Controller of Personal Data Processed by Institution with respect to the medical treatment of the StudySubject.
Personal Data of Study Subjects. [Xx xX] will be an independent Controller with respect to its Processing of Personal Data contained in the Study Data and Biological Samples that are reported by Institution or Principal Investigator to [Xx xX] or otherwise created by [Xx xX]. Institution or Principal Investigator is the Controller of Personal Data Processed by Institution with respect to the medical treatment of the StudySubject.
Personal Data of Study Subjects. 6.2.1 Sponsor, as Controller of the Personal Data of Study Subjects processed for the purpose of the Study (“Study-related Personal Data of Study Subjects”), delegated processing of Study- related Personal Data of Study subjects, including, without limitation, Study-related data on medical condition of Study Subjects, to Institution. The scope of such processing and of the data processed is defined by the case report forms (CRFs) used in this Study and by the Protocol.
6.2.2 Study-related Personal Data of Study Subjects will be obtained by Institution in compliance with the Protocol from source data documents (e.g. Study Subjects’ medical records of visits) and/or directly from Study Subjects (e.g. from interviews or questionnaires). Investigator and/or Study Staff enter these data in pseudonymized form into CRFs provided by ▇▇▇▇▇▇▇, who subjects them to processing, which includes, without limitation, sorting, evaluating and storing of such Personal Data. Study-related Personal Data of Study Subjects are further processed by ▇▇▇▇▇▇▇’s authorized representatives who verify that CRF entries correspond to source data documents in the presence and in cooperation with Investigator and/or Study Staff.
6.2.3 Institution undertakes to process Study- related Personal Data of Study Subjects for as long as required to meet the purpose of this Agreement, but in no event longer that the maximum period allowed by applicable laws (unless Personal Data are processed for another purpose than to meet a legal obligation).
6.2.4 Institution is obliged to process Study- related Personal Data of Study Subjects in compliance with this Agreement. Institution is obliged to ensure that such Personal Data processed under this Agreement are protected in compliance with GDPR, which includes, without limitation:
a) processing Study-related Personal Data of Study Subjects only as necessary to perform all obligations arising out of this Agreement, and in compliance with the Protocol and Sponsor’s instructions;
Personal Data of Study Subjects. Medivation shall be an independent Controller with respect to its Processing of Personal Data contained in the Study data that is reported by Institution to Medivation or IQVIA . Institution shall continue to be an independent Controller of Personal Data Processed by Institution with respect to the treatment of the Study subject pursuant to medical standard of care and applicable legal obligations. Institution agrees to obtain from each Study subject, prior to that individual’s participation in the Study, a signed informed consent, approved in writing by Medivation or IQVIA and by any applicable ethics committee, and which shall include the necessary content to allow for the Processing of the Study subject’s Personal Data for the purposes described in the Study protocol and the Agreement. 2. O sobné údaje subjektov skúšania. Spoločnosť Medivation bude nezávislým prevádzkovateľom osobných údajov vo vzťahu k svojmu spracovávaniu osobných údajov obsiahnutých v údajoch skúšania, nahlásených zdravotníckym zariadením alebo spoločnosti Medivation alebo IQVIA. Zdravotnícke zariadenie naďalej zostáva nezávislým prevádzkovateľom osobných údajov spracovávaných zdravotníckym zaradením v súvislosti s liečbou subjektov skúšania v súlade so štandardnou zdravotnou starostlivosťou a platnými zákonnými povinnosťami. Zdravotnícke zariadenie sa zaväzuje získať od každého subjektu skúšania pred jeho účasťou na skúšaní podpísaný informovaný súhlas písomne schválený spoločnosťou Medivation alebo IQVIA a každou príslušnou etickou komisiou, ktorý má obsahovať potrebné znenie umožňujúce spracovávať osobné údaje subjektov skúšania na účely uvedené v protokole skúšania a zmluve.
