Dokumentace a zpracování formulářů CRF Sample Clauses

Dokumentace a zpracování formulářů CRF. Kromě formulářů pro záznamy údajů (Case Report Forms, dále také jako „CRF“) povede Hlavní zkoušející pro každý subjekt, jenž se Klinického hodnocení zúčastní, také veškeré lékařské (zdravotní) záznamy (v papírové podobě nebo jako výtisky elektronických souborů). Tyto lékařské záznamy budou každý subjekt Klinického hodnocení jasně identifikovat, a pokud zároveň slouží i jako zdrojové dokumenty, musí v nich být veškeré zápisy do CRF dohledatelné. Formuláře CRF musí u každého subjektu odrážet jeho současný stav v rámci Klinického hodnocení a po návštěvě subjektu je Hlavní zkoušející nebo jeho zmocněný zástupce musí okamžitě vyplnit a podepsat. Hlavní zkoušející zaručuje, že veškeré CRF předložené PAREXELU nebo ZADAVATELI budou pravdivé, kompletní a správné a budou přesně odrážet výsledky Klinického hodnocení. Hlavní zkoušející se zavazuje, že PAREXELU a ZADAVATELI a jejich zmocněným zástupcům na jejich žádost přímo zpřístupní všechny záznamy související s Klinickým hodnocením, včetně zdravotních záznamů pacienta.
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Related to Dokumentace a zpracování formulářů CRF

  • Conhecimento da Lingua O Contratado, pelo presente instrumento, declara expressamente que tem pleno conhecimento da língua inglesa e que leu, compreendeu e livremente aceitou e concordou com os termos e condições estabelecidas no Plano e no Acordo de Atribuição (“Agreement” xx xxxxxx).

  • Hepatitis B Vaccine Where the Hospital identifies high risk areas where employees are exposed to Hepatitis B, the Hospital will provide, at no cost to the employees, a Hepatitis B vaccine.

  • DUŠEVNÍ VLASTNICTVÍ a) The Institution and the Investigator acknowledge and agree that the Sponsor shall have exclusive ownership rights to all Study Data, Study results, information, improvements, developments, discoveries, inventions, work, know-how and other rights (whether or not patentable), created, developed, and/or reduced to practice as a result of or in connection with the conduct of the Study and/or the use of the Study Drug or the Confidential Information, together with all intellectual property rights (existing and future) relating thereto (“Intellectual Property”) conceived by the Institution or the Investigator or Study Personnel, solely or jointly with others as a result of work done under this Agreement, to the widest extent possible under applicable law. The Institution and the Investigator shall promptly disclose in writing to PSI and the Sponsor all Intellectual Property made or reduced to practice by the Institution, the Investigator and/or the Study Personnel related to the Study. At the Sponsor's request, the Institution and the Investigator shall cause all rights titles and interests in and to any such Intellectual Property to be assigned to the Sponsor without additional compensation and provide reasonable assistance to obtain patents, including causing the execution of any invention assignment or other documents. b) All parties to this Agreement and Sponsor shall retain all right, title and interest in any Intellectual Property that was owned by such party or Sponsor prior to or apart from the commencement of this Agreement. No a) Zdravotnické zařízení a Hlavní zkoušející uznávají a souhlasí, že Zadavatel bude mít výhradní vlastnická práva ke všem Studijním údajům, výsledkům Studie, informacím, vylepšením, na vývoj, k objevům, vynálezům, dílům, know-how a dalším právům (ať už patentovatelným či nikoli), vytvořeným, vyvinutým, a/nebo uvedeným do praxe v důsledku nebo v souvislosti s prováděním Studie, a/nebo používáním Studijního léku nebo Důvěrných informací společně s právy duševního vlastnictví (stávajícími i budoucími) s nimi souvisejícími (dále jen „Duševní vlastnictví“), které vytvořilo Zdravotnické zařízení, Hlavní zkoušející nebo Studijní personál, samostatně nebo společně s ostatními jako výsledek práce prováděné na základě této Smlouvy, a to v největším možném rozsahu povoleném příslušnými zákonnými předpisy. Zdravotnické zařízení a Hlavní zkoušející budou neprodleně písemně informovat PSI a Zadavatele o veškerém Duševním vlastnictví vytvořeném nebo uvedeném do praxe Zdravotnickým zařízením, Hlavním zkoušejícím a/nebo Studijním personálem v souvislosti se Studií. Na žádost Zadavatele zajistí Zdravotnické zařízení a Hlavní zkoušející převod veškerých práv a zájmů týkajících se Duševního vlastnictví na Zadavatele bez další odměny a poskytnou přiměřenou součinnost k získání patentu včetně zajištění podpisu dokumentů k převodu objevu nebo jiných dokumentů. b) Všechny strany této Smlouvy a Zadavatel si i nadále ponechají veškerá práva, nároky a podíly na jakémkoli Duševním vlastnictví, které daná strana nebo Zadavatel vlastnili před začátkem platnosti této Smlouvy nebo na které license grant or assignment, express or implied, by estoppel or otherwise, is intended by, or shall be inferred from, this Agreement except to the extent necessary for each party to fulfill its obligations under this Agreement or otherwise give effect to this Agreement.

  • Vlastnictví Zdravotnické zařízení si ponechá a bude uchovávat Zdravotní záznamy. Zdravotnické zařízení a Zkoušející převedou na Zadavatele veškerá svá práva, nároky a tituly, včetně práv duševního vlastnictví k Důvěrným informacím (ve smyslu níže uvedeném) a k jakýmkoli jiným Studijním datům a údajům.

  • COVID-19 Vaccine Passports Pursuant to Texas Health and Safety Code, Section 161.0085(c), Contractor certifies that it does not require its customers to provide any documentation certifying the customer’s COVID-19 vaccination or post-transmission recovery on entry to, to gain access to, or to receive service from the Contractor’s business. Contractor acknowledges that such a vaccine or recovery requirement would make Contractor ineligible for a state-funded contract.

  • Durable Medical Equipment (DME), Medical Supplies, Prosthetic Devices, Enteral Formula or Food, and Hair Prosthesis (Wigs) This plan covers durable medical equipment and supplies, prosthetic devices and enteral formula or food as described in this section. DME is equipment which: • can withstand repeated use; • is primarily and customarily used to serve a medical purpose; • is not useful to a person in the absence of an illness or injury; and • is for use in the home. DME includes supplies necessary for the effective use of the equipment. This plan covers the following DME: • wheelchairs, hospital beds, and other DME items used only for medical treatment; and • replacement of purchased equipment which is needed due to a change in your medical condition or if the device is not functional, no longer under warranty, or cannot be repaired. DME may be classified as a rental item or a purchased item. In most cases, this plan only pays for a rental DME up to our allowance for a purchased DME. Repairs and supplies for rental DME are included in the rental allowance. Medical supplies are consumable supplies that are disposable and not intended for re- use. Medical supplies require an order by a physician and must be essential for the care or treatment of an illness, injury, or congenital defect. Covered medical supplies include: • essential accessories such as hoses, tubes and mouthpieces for use with medically necessary DME (these accessories are included as part of the rental allowance for rented DME); • catheters, colostomy and ileostomy supplies, irrigation trays and surgical dressings; and • respiratory therapy equipment. This plan covers diabetic equipment and supplies for the treatment of diabetes in accordance with R.I. General Law §27-20-30. Covered diabetic equipment and supplies include: • therapeutic or molded shoes and inserts for custom-molded shoes for the prevention of amputation; • blood glucose monitors including those with special features for the legally blind, external insulin infusion pumps and accessories, insulin infusion devices and injection aids; and • lancets and test strips for glucose monitors including those with special features for the legally blind, and infusion sets for external insulin pumps. The amount you pay differs based on whether the equipment and supplies are bought from a durable medical equipment provider or from a pharmacy. See the Summary of Pharmacy Benefits and the Summary of Medical Benefits for details. Coverage for some diabetic equipment and supplies may only be available from either a DME provider or from a pharmacy. Visit our website to determine if this is applicable or call our Customer Service Department. Prosthetic devices replace or substitute all or part of an internal body part, including contiguous tissue, or replace all or part of the function of a permanently inoperative or malfunctioning body part and alleviate functional loss or impairment due to an illness, injury or congenital defect. Prosthetic devices do not include dental prosthetics. This plan covers the following prosthetic devices as required under R.I. General Law § 27-20-52: • prosthetic appliances such as artificial limbs, breasts, larynxes and eyes; • replacement or adjustment of prosthetic appliances if there is a change in your medical condition or if the device is not functional, no longer under warranty and cannot be repaired; • devices, accessories, batteries and supplies necessary for prosthetic devices; • orthopedic braces except corrective shoes and orthotic devices used in connection with footwear; and • breast prosthesis following a mastectomy, in accordance with the Women’s Health and Cancer Rights Act of 1998 and R.I. General Law 27-20-29. The prosthetic device must be ordered or provided by a physician, or by a provider under the direction of a physician. When you are prescribed a prosthetic device as an inpatient and it is billed by a provider other than the hospital where you are an inpatient, the outpatient benefit limit will apply. Enteral formula or food is nutrition that is absorbed through the intestinal tract, whether delivered through a feeding tube or taken orally. Enteral nutrition is covered when it is the sole source of nutrition and prescribed by the physician for home use. In accordance with R.I. General Law §27-20-56, this plan covers enteral formula taken orally for the treatment of: • malabsorption caused by Crohn’s Disease; • ulcerative colitis; • gastroesophageal reflux; • chronic intestinal pseudo obstruction; and • inherited diseases of amino acids and organic acids. Food products modified to be low protein are covered for the treatment of inherited diseases of amino acids and organic acids. Preauthorization may be required. The amount that you pay may differ depending on whether the nutrition is delivered through a feeding tube or taken orally. When enteral formula is delivered through a feeding tube, associated supplies are also covered. This plan covers hair prosthetics (wigs) worn for hair loss suffered as a result of cancer treatment in accordance with R.I. General Law § 27-20-54 and subject to the benefit limit and copayment listed in the Summary of Medical Benefits. This plan will reimburse the lesser of the provider’s charge or the benefit limit shown in the Summary of Medical Benefits. If the provider’s charge is more than the benefit limit, you are responsible for paying any difference. This plan covers Early Intervention Services in accordance with R.I. General Law §27- 20-50. Early Intervention Services are educational, developmental, health, and social services provided to children from birth to thirty-six (36) months. The child must be certified by the Rhode Island Department of Human Services (DHS) to enroll in an approved Early Intervention Services program. Services must be provided by a licensed Early Intervention provider and rendered to a Rhode Island resident. Members not living in Rhode Island may seek services from the state in which they reside; however, those services are not covered under this plan. Early Intervention Services as defined by DHS include but are not limited to the following: • speech and language therapy; • physical and occupational therapy; • evaluation; • case management; • nutrition; • service plan development and review; • nursing services; and • assistive technology services and devices.

  • Commercial Supply After the Option Termination Date: (a) if requested by Kolltan, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.

  • Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

  • Prosthodontics We Cover prosthodontic services as follows:

  • CUKAI Jualan hartanah tersebut akan dikenakan cukai berdasarkan mana-mana Akta terkini atau selepasnya yang dikuatkuasa oleh Kerajaan Malaysia yang mana berkenaan. Sebarang tunggakan caj perkhidmatan atau penyelenggaraan tanpa faedah penalti lewat (jika ada) yang tertunggak xxx perlu dibayar kepada mana-mana pihak berkuasa yang berkenaan xxx/atau pihak Pemaju akan ditanggung oleh pihak Pemegang Xxxxx Xxx/Pemberi Pinjaman setakat tarikh jualan lelongan hartanah tersebut (tertakluk kepada maksimum 10% daripada harga rizab) yang akan dibayar daripada harga pembelian, dengan syarat bahawa Pemegang Xxxxx Xxx/Pemberi Pinjaman menerima xxx xxxx terperinci untuk caj perkhidmatan penyelenggaraan xxx penyata akaun yang dikeluarkan oleh pihak berkuasa xxx/atau pemaju yang berkaitan daripada Pembeli dalam tempoh sembilan puluh (90) hari dari tarikh jualan xxx jika gagal pembeli tidak akan layak untuk apa-apa pembayaran, xxx sebarang jumlah tertunggak yang perlu dibayar selepas tarikh jualan lelongan hartanah tersebut hendaklah ditanggung oleh pembeli.

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