Rights of Data Subjects Participating in the Study post Study Closure Sample Clauses

Rights of Data Subjects Participating in the Study post Study Closure. Contractor will promptly notify Pfizer of any such withdrawal of consent that may affect the use of the Personal Data under the Agreement and any other instructions provided by Pfizer. Such requests may be directed to Pfizer at Xxxxxxxx_xxxxxxxxxxx@xxxxxx.xxx.
Sample 1
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Rights of Data Subjects Participating in the Study post Study Closure. Institution will promptly notify Pfizer of any such withdrawal of consent that may affect the use of the Personal Data under the Agreement orgánům státní správy, pokud to vyžaduje zákon, a bude odpovědná za podání takového oznámení.
Sample 1
Rights of Data Subjects Participating in the Study post Study Closure. Institution will promptly notify Pfizer of any such 9. Práva subjektů Údajů, které se Účastní Studie, po uzavření Studie. Instituce neprodleně oznámí společnosti Pfizer každé withdrawal of consent that may affect the use of the Personal Data under the Agreement and any other instructions provided by Pfizer. Such requests may be directed to Pfizer at @xxxxxx.xxx takové odvolání souhlasu, které může mít vliv na použití Osobních údajů podle této Smlouvy a jakékoli jiné pokyny poskytnuté společností Pfizer. Tyto žádosti mohou být směrovány na e-mailovou adresu společnosti Pfizer @xxxxxx.xxx 10. Cross-Border Data Transfers. Institution will only Transfer Personal Data outside the European Union, European Economic Area or Switzerland in accordance with Study related instructional documents provided by Pfizer. If requested by either Institution or Pfizer (or by CRO on behalf of Pfizer), Institution and Pfizer will enter into an agreement governing such Transfer, including, but not limited to the EU Standard Contractual Clauses, unless another adequate mechanism for the Transfer exists. 10. Přeshraniční Přenosy údajů. Instituce uskuteční Přenos Osobních údajů mimo Evropský hospodářský prostor nebo Švýcarsko pouze v souladu s příslušnými instrukcemi, které jí v souvislosti se Studií poskytne společnost Pfizer. Požádá- li o to Instituce nebo společnost Pfizer (nebo CRO jménem společnosti Pfizer), uzavře Instituce se společností Pfizer dohodu upravující takový Převod, zahrnující, ale ne omezenou pouze na Standardní smluvní doložky EU, pokud nebude existovat jiný přiměřený mechanismus pro Převod.
Sample 1
Rights of Data Subjects Participating in the Study post Study Closure. Institution will promptly notify Pfizer of any such withdrawal of consent that may affect the use of the Personal Data under the Agreement and any other instructions provided by Pfizer. Such requests may be directed to Pfizer at ████████████ 10. Cross-Border Data Transfers. Institution will only Transfer Personal Data outside the European Union, European Economic Area or Switzerland in accordance with Study related instructional documents provided by Pfizer. If requested by either Institution or Pfizer (or by CRO on behalf of Pfizer), Institution and Pfizer will enter into an (e) Inštitúcia bude zodpovedná za všetky náklady, výdavky, ako aj akékoľvek následné sankcie, súvisiace s vykonaním takýchto oznámení. Inštitúcia takisto vykoná všetky potrebné kroky na nápravu a zmiernenie Bezpečnostného incidentu na vlastné náklady. 8 Práva dotknutých osôb zúčastňujúcich sa klinického skúšania. Inštitúcia a spoločnosť Pfizer sa dohodli na tom, že spomedzi nich je inštitúcia najschopnejšia spravovať žiadosti xx xxxxxx xxxxxxxxxx xxxxxxxxxx xxxxxxxx o sprístupnenie, zmenu, Prenos, obmedzenie alebo vymazanie osobných údajov. V prípade, že spoločnosť Pfizer a/alebo CRO dostane žiadosť xx xxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxx o takéto sprístupnenie, zmenu, Prenos, obmedzenie alebo vymazanie, spoločnosť Pfizer alebo CRO môže postúpiť túto žiadosť inštitúcii. Inštitúcia odpovie na žiadosť xx xxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxx o sprístupnenie, zmenu, Prenos, obmedzenie alebo vymazanie Osobných údajov v súlade s Príslušným zákonom, a so zmluvou a s akýmikoľvek inými pokynmi vydanými spoločnosťou Pfizer. Inštitúcia berie na vedomie, že kvôli zachovaniu integrity výsledkov klinického skúšania možnosť zmeniť, obmedziť alebo vymazať Osobné údaje môže byť obmedzená v súlade s Príslušným zákonom. Spoločnosť Pfizer berie na vedomie, xx xxxxxxxxx xxxxxxxxxx xxxxxxxx môžu kedykoľvek odvolať svoj informovaný súhlas s účasťou v klinickom skúšaní a svoj súhlas so Spracúvaním Osobných údajov. 9. Práva dotknutých osôb zúčastňujúcich sa klinického skúšania po ukončení klinického skúšania. Inštitúcia bezodkladne oznámi spoločnosti Pfizer akékoľvek odvolanie súhlasu, ktoré by mohlo ovplyvniť používanie Osobných údajov podľa tejto zmluvy a akýchkoľvek iných pokynov vydaných spoločnosťou Pfizer. Takéto žiadosti môžu byť adresované spoločnosti Pfizer prostredníctvom adresy ████████████ 10. Cezhraničné Prenosy údajov. Inštitúcia bude Odosielať Osobné údaje mimo Európskej únie, Európskeho hospod...
Sample 1
Rights of Data Subjects Participating in the Study post Study Closure. Institution will promptly notify Pfizer of any such withdrawal of consent that may affect the use of the Personal Data under the Agreement and any other instructions provided by Pfizer. Such requests may be directed to Pfizer at . 10. Cross-Border Data Transfers. Institution will only Transfer Personal Data outside the European Union, European Economic Area or Switzerland in accordance with Study related instructional documents provided by Pfizer. If requested by either Institution or Pfizer (or by CRO on behalf of Pfizer), Institution and Pfizer will enter into an agreement governing such Transfer, including, but not limited to the EU Standard Contractual Clauses, unless another adequate mechanism for the Transfer exists. 11.
Sample 1
Rights of Data Subjects Participating in the Study post Study Closure. Institution will promptly notify XXX of any such withdrawal of consent that may affect the use of the Personal Data under the Agreement and any other instructions provided by XXX. Such requests may be directed to XXX at XXXXXXX
Sample 1
Rights of Data Subjects Participating in the Study post Study Closure. Institution will promptly notify Pfizer of any such withdrawal of consent that may affect the use of the Personal Data under the 9. Práva subjektů Údajů, které se Účastní Studie, po uzavření Studie. Instituce neprodleně oznámí společnosti Pfizer každé takové odvolání souhlasu, které může mít vliv na použití Osobních Agreement and any other instructions provided by Pfizer. Such requests may be directed to Pfizer at XXXXXXXXX údajů podle této Smlouvy a jakékoli jiné pokyny poskytnuté společností Pfizer. Tyto žádosti mohou být směrovány na e-mailovou adresu společnosti Pfizer XXXXXXXXX
Sample 1
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Related to Rights of Data Subjects Participating in the Study post Study Closure

  • 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.

  • Schedule for Completing Agreement Closeout Activities Provide All Draft and Final Written Products on a CD-ROM or USB memory stick, organized by the tasks in the Agreement. Products: • Final Meeting Agreement Summary (if applicable) • Schedule for Completing Agreement Closeout Activities • All Draft and Final Written Products

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • TECHNOLOGY/KNOWLEDGE TRANSFER ACTIVITIES The goal of this task is to develop a plan to make the knowledge gained, experimental results, and lessons learned available to the public and key decision makers. The Recipient shall: • Prepare an Initial Fact Sheet at start of the project that describes the project. Use the format provided by the CAM. • Prepare a Final Project Fact Sheet at the project’s conclusion that discusses results. Use the format provided by the CAM. • Prepare a Technology/Knowledge Transfer Plan that includes: o An explanation of how the knowledge gained from the project will be made available to the public, including the targeted market sector and potential outreach to end users, utilities, regulatory agencies, and others.

  • Proposing Integration Activities in the Planning Submission No integration activity described in section 6.3 may be proposed in a CAPS unless the Funder has consented, in writing, to its inclusion pursuant to the process set out in section 6.3(b).

  • Vaccination and Inoculation (a) The Employer agrees to take all reasonable precautions, including in-service seminars, to limit the spread of infectious diseases among employees.

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