Personal Data of Study Subjects Sample Clauses

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 and Principal Investigator to Pfizer or CRO. Institution and Principal Investigator shall continue to be an independent Controller of Personal Data Processed by Institution and Principal Investigator with respect to the treatment of the Study subject pursuant to medical standard of care and applicable legal obligations. Institution and Principal Investigator agree 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. 2. Osobní údaje subjektů hodnocení. Společnost Pfizer bude nezávislým Správcem, co se týká Zpracovávání Osobních údajů obsažených v údajích Studie, které předává Zdravotnické zařízení a Hlavní zkoušející společnosti Pfizer nebo CRO. Zdravotnické zařízení a Hlavní zkoušející budou nadále nezávislým Správcem Osobních údajů zpracovávaných Zdravotnickým zařízením a Hlavním zkoušejícím s ohledem na léčbu subjektů hodnocení podle standardů lékařské péče a příslušných právních povinností. Zdravotnické zařízení a Hlavní zkoušející souhlasí s tím, že před individuální účastí ve Studii získá od každého subjektu hodnocení podepsaný informovaný souhlas, písemně schválený společností Pfizer nebo CRO a příslušnou etickou komisí, který bude zahrnovat nezbytný obsah dovolující Zpracovávání Osobních údajů subjektu hodnocení pro účely popsané v protokolu Studie a Smlouvě.
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Personal Data of Study Subjects. Pfizer 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 Pfizer or otherwise created by Pfizer. Institution or Principal Investigator is the Controller of Personal Data Processed with respect to the medical treatment of the Study Subject.
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. 2. Osobní údaje pacientů ve studii. Společnost Pfizer bude nezávislým správcem, pokud jde o zpracování osobních údajů obsažených v údajích ze studie, které zdravotnické zařízení nebo hlavní zkoušející oznámí společnosti Pfizer nebo které společnost Pfizer jinak vytvoří. Hlavní zkoušející je správcem osobních údajů zpracovávaných hlavním zkoušejícím v souvislosti s lékařskou péčí o pacienta ve studii.
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.
Personal Data of Study Subjects. Pfizer 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, within their Processor capacity, 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 Study Subject and in regards to their medical documentation/patient charts. 2. Osobní údaje subjektů Studie. Společnost Pfizer bude nezávislým Správcem, co se týká Zpracování Osobních údajů obsažených v údajích Studie a Biologických vzorcích, které předává Instituce nebo Hlavní zkoušející společnosti Pfizer, z pozice Zpracovatele, nebo jsou jinak vytvořené společností Pfizer. Instituce nebo Hlavní zkoušející budou Správcem Osobních údajů Zpracovávaných Institucí s ohledem na lékařskou péči subjektů Studie a jejich zdravotnickou dokumentaci.
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. 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.
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Related to Personal Data of Study Subjects

  • Processing Personal Data 40.1. The Company is the data controller in the relevant jurisdiction. You hereby acknowledge and agree to the collection and processing of personal data provided by you in connection with the opening of a trading account for the purpose of performing our obligations under these Terms and Conditions and for administering the relationship between you and us.

  • Personal Data Processing 2.1 The Processor shall process Personal Data only on the basis of corresponding recorded orders from the Controller.

  • Personal Data Registry Operator shall (i) notify each ICANN-­‐accredited registrar that is a party to the registry-­‐registrar agreement for the TLD of the purposes for which data about any identified or identifiable natural person (“Personal Data”) submitted to Registry Operator by such registrar is collected and used under this Agreement or otherwise and the intended recipients (or categories of recipients) of such Personal Data, and (ii) require such registrar to obtain the consent of each registrant in the TLD for such collection and use of Personal Data. Registry Operator shall take reasonable steps to protect Personal Data collected from such registrar from loss, misuse, unauthorized disclosure, alteration or destruction. Registry Operator shall not use or authorize the use of Personal Data in a way that is incompatible with the notice provided to registrars.

  • Shared Personal Data This clause sets out the framework for the sharing of personal data between the parties as data controllers. Each party acknowledges that one party (the Data Discloser) will regularly disclose to the other party (the Data Recipient) Shared Personal Data collected by the Data Discloser for the Agreed Purposes.

  • Processing of Personal Data (a) SORACOM collects and processes personal data about the Subscriber, including name, e-mail, IP-address as well as data on data uses and billing data in order to provide SORACOM’s service and other purposes such as billing.

  • Transfer of Personal Data The Participant authorizes, agrees and unambiguously consents to the transmission by the Company (or any Subsidiary) of any personal data information related to the Option awarded under this Agreement for legitimate business purposes (including, without limitation, the administration of the Plan). This authorization and consent is freely given by the Participant.

  • Handling Sensitive Personal Information and Breach Notification A. As part of its contract with HHSC Contractor may receive or create sensitive personal information, as section 521.002 of the Business and Commerce Code defines that phrase. Contractor must use appropriate safeguards to protect this sensitive personal information. These safeguards must include maintaining the sensitive personal information in a form that is unusable, unreadable, or indecipherable to unauthorized persons. Contractor may consult the “Guidance to Render Unsecured Protected Health Information Unusable, Unreadable, or Indecipherable to Unauthorized Individuals” issued by the U.S. Department of Health and Human Services to determine ways to meet this standard.

  • Transfer of Personal Information Supplier warrants to DXC that Personal Information provided to Supplier or obtained by Supplier under this Agreement on behalf of DXC (including any SOW) shall not be transferred across national boundaries unless authorized by law or specified within this Agreement or the applicable SOW as authorized for transfer across national boundaries. Supplier agrees that any such transfer will only be made in compliance with applicable Data Privacy Laws. If there is a conflict between this Section ‘Data Protection and Privacy’ and the other provisions of this Agreement, the requirements of this Section shall take precedence.

  • Study Population The study was based at the San Francisco KPNC Anal Cancer Screening Clinic. We enrolled men who were identified as positive for HIV through the Kaiser HIV registry, who were aged ≥ 18 years, who were not diag- nosed with anal cancer before enrollment, and who pro- vided informed consent. In total, 363 men were enrolled between August 2009 and June 2010. The study was reviewed and approved by the institutional review boards at KPNC and at the National Cancer Institute. All partici- pants were asked to complete a self-administered ques- tionnaire to collect risk factor information. Additional information regarding HIV status and medication, sexu- ally transmitted diseases, and histopathology results were abstracted from the KPNC clinical database. For 87 of the 271 subjects without biopsy-proven AIN2 or AIN3 at the time of enrollment, follow-up infor- mation concerning outcomes from additional clinic visits up to December 2011 was available and included in the analysis to correct for the possible imperfect sensitivity of high-resolution anoscopy (HRA).13,15 Clinical Examination, Evaluation, and Results During the clinical examination, 2 specimens were col- lected by inserting a wet flocked nylon swab16 into the anal canal up to the distal rectal vault and withdrawing with rotation and lateral pressure. Both specimens were trans- ferred to PreservCyt medium (Hologic, Bedford, Mass). A third specimen was collected for routine testing for Chla- mydia trachomatis and Neisseria gonorrhea. After specimen collection, participants underwent a digital anorectal ex- amination followed by HRA. All lesions that appeared sus- picious on HRA were biopsied and sent for routine histopathological review by KPNC pathologists, and were subsequently graded as condyloma or AIN1 through AIN3. No cancers were observed in this study population. From the first specimen, a ThinPrep slide (Hologic) was prepared for routine Xxxxxxxxxxxx staining and xxxxx- xxxxx. Two pathologists (T.D. and D.T.) reviewed the slides independently. Cytology results were reported anal- ogous to the Bethesda classification17 for cervical cytology except when otherwise noted. The following categories were used: negative for intraepithelial lesion or malig- xxxxx (NILM); ASC-US; atypical squamous cells cannot rule out high-grade squamous intraepithelial lesion (HSIL) (ASC-H); low-grade squamous intraepithelial lesion (LSIL); HSIL, favor AIN2 (HSIL-AIN2); and HSIL-AIN3. ASC-H, HSIL-AIN2, and HSIL-AIN3 were combined into a single high-grade cytology category for the current analysis. Biomarker Testing Using the residual specimen from the first collection, mtm Laboratories AG (Heidelberg, Germany) performed the p16INK4a/Ki-67 dual immunostaining (‘‘p16/Ki-67 staining’’) using their CINtec Plus cytology kit according to their specifications. A ThinPrep 2000 processor (Holo- gic) was used to prepare a slide, which then was stained according to the manufacturer’s instructions. The CINtec Plus cytology kit was then applied to the unstained cytol- ogy slide for p16/Ki-67 staining. On the second collected specimen, Roche Molecular Systems (Pleasanton, Calif) tested for HR-HPV, includ- ing separate detection of HPV-16, and HPV-18 DNA, using their cobas 4800 HPV test. To prepare DNA for the cobas test, automated sample extraction was per- formed as follows: 500 lL of the PreservCyt specimen was pipetted into a secondary tube (Falcon 5-mL polypropyl- ene round-bottom tube, which measured 12-mm-by-75- mm and was nonpyrogenic and sterile). The tube was capped, mixed by vortexing, uncapped, placed on the x-480 specimen rack, and loaded onto the x-480 sample extraction module of the cobas 4800 system. The x-480 extraction module then inputs 400 lL of this material into the specimen preparation process. The extracted DNA was then tested as previously described.16 NorChip AS (Klokkarstua, Norway) also tested the second specimen for HPV-16, -18, -31, -33, and -45 HPV E6/E7 mRNA using their PreTect HPV-Proofer assay according to their specifications. All testing was per- formed masked to the results of the other assays, clinical outcomes, and patient characteristics.

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