Informovaný súhlas Sample Clauses

Informovaný súhlas. Site shall obtain the prior written informed consent of each Study Subject prior to any Study procedure being performed. Site shall use an informed consent form that has been approved by Study Sponsor and is in accordance with Applicable Law and the requirements of the Institutional Review Board (“IRB”) or Independent Ethics Committee (“IEC”) that is responsible for reviewing the Study. Pracovisko skúšania sa zaväzuje použiť dokument informovaného súhlasu, ktorý bol schválený zadávateľom a spĺňa všetky platné nariadenia a požiadavky nezávislej etickej komisie, ktorá je zodpovedná za posúdenie skúšania. Pracovisko skúšania najprv získa od každého subjektu skúšania písomný informovaný súhlas.
Sample 1
AutoNDA by SimpleDocs
Informovaný súhlas. Zodpovedný skúšajúci získa od každej osoby zúčastňujúcej sa klinického skúšania (ďalej len „účastník klinického skúšania“) platný informovaný súhlas (ďalej len „informovaný súhlas“), podpísaný účastníkom klinického skúšania (ak EK nerozhodne, že takýto podpis sa nevyžaduje) a riadne zdokumentovaný. Inštitúcia/zodpovedný skúšajúci musia vykonávať klinické skúšanie spôsobom, ktorý je v súlade s informovaným súhlasom.
Sample 1
Informovaný súhlas. 4.1 The Institution represents and warrants that it will obtain informed consent from each subject (or his/her legal representative) on a form approved by Sponsor and prior to such 4.1 Zdravotnícke zariadenie vyhlasuje a zaručuje, že od každého subjektu (alebo jeho zákonného zástupcu) získa informovaný súhlas na dokumente schválenom zadávateľom, a to pred subject’s enrollment in the Study and prior to the commencement of any Study-related procedure. The method of explanation to the subject (or his/her legal representative) and the obtaining of the consent should be conducted in accordance with all Applicable Regulations, Institutional Review Board and/or Ethics Committee (“IRB/EC”) instructions and is the responsibility of the Investigator. Each subject (or his/her legal representative) will be provided with a photocopy of his or her signed and dated informed consent form, the original of which shall be placed in the respective subject’s Study’s file. zaradením takéhoto subjektu do skúšania a skôr, než sa začne akýkoľvek postup súvisiaci so skúšaním. Spôsob vysvetlenia informácií subjektu (alebo jeho zákonnému zástupcovi) a získania súhlasu musí prebiehať v súlade so všetkými platnými predpismi a s pokynmi etickej komisie (ďalej „EK“) a zodpovedá zaň skúšajúci. Každému subjektu (alebo jeho zákonnému zástupcovi) sa poskytne fotokópia podpísaného a datovaného dokumentu informovaného súhlasu, ktorého originál bude uložený v zložke skúšania príslušného subjektu. 4.2 The Institution represents and warrants that the informed consent form will include authorization to use and disclose such subject’s medical information that conforms to all Applicable Regulations (collectively, the “Authorization”). Such Authorization shall include permission to disclose such subject’s pseudonymized (coded) health information to, and re-disclosure among, the Sponsor, its affiliated companies, collaborators, service providers, contractors and agents, other Study investigators and the appropriate regulatory authorities. Such Authorization shall also include permission to disclose the subject’s medical records, laboratory results and other documents to the Sponsor and its authorized representatives for monitoring, auditing and inspection purposes.
Sample 1
Informovaný súhlas. 6.1 Skúšajúci bude zodpovedný za získanie podpísaného informovaného súhlasu od každého Účastníka klinickej štúdie ešte pred jeho účasíou v Klinickej štúdii. 6.2 Zmluvné strany súhlasia s tým a berú na vedomie, že formulár informovaného súhlasu je primeraný na: 1) poskytnutie všetkých dôležitých informácií o Klinickej štúdii, aby sa potenciálni účastníci mohli rozhodnúí, či sa chcú zaregistrovaí (alebo v prípade zaregistrovania, či sa chcú Klinickej štúdie ďalej zúčastňovaí); 2) zaistenie toho, aby potenciálni účastníci pochopili riziká a potenciálny prínos účasti v Klinickej štúdii a alternatívy vykonávaného výskumu; a 3) zdôraznenie toho, že registrácia (alebo zotrvanie) v Klinickej štúdii je úplne dobrovoľná. Keďže poskytnutie súhlasu s účasíou na výskume nie je zmluva, účastníci môžu zo štúdie kedykoľvek vystúpií. 4) poskytnutie primeraných informácií o ochrane osobných údajov. 6.3 Zariadenie a Skúšajúci súhlasia s tým a zaručujú, že budú promptne reagovaí na všetky žiadosti zaregistrovaných Účastníkov o stiahnutie súhlasu a že okamžite zastavia účasí tých Účastníkov, ktorí o to požiadali. - arising out of or relating to the administration of the Investigational Product in accordance with the Protocol or any clinical intervention or procedure provided for or required by the Protocol to which the Clinical Study Subjects would not have been exposed but for their participation in the Clinical Study; - arising out of or relating to the negligence or wilful misconduct of Sponsor in performing its obligations under this Agreement; - arising out of or relating to the violation of Applicable Law related to the conduct of the Clinical Study by Sponsor; or - arising out of or relating to the breach of any provision of this Agreement by Sponsor. 7.2 The Institution agrees to defend, indemnify and hold harmless the Sponsor, the Investigators and their respective directors, officers, employees and Agents (the “Indemnitees”) against any liability or loss resulting from judgments or claims made or brought by a third party against an Indemnitee for harm: - arising out of or relating to the negligence or wilful misconduct of the Institution, its employees and Agents in performing their obligations under this Agreement; - arising out of errors or omissions by Institution; - arising out of or relating to the failure of the Institution, its employees and Agents to comply with the provisions of this Agreement, the Protocol, or any written instructions of Sponsor concerning ...
Sample 1
Informovaný súhlas. Zdravotnícke zariadenie a hlavný skúšajúci zaistia, aby každý účastník skúšania riadne podpísal formulár informovaného súhlasu („ICF“), ktorý musí byť v súlade s príslušným zákonom, ako je schválený zadávateľom, poverencom zadávateľa (Syneos Health) a IEC, a ak je to vyžadované, aj príslušným orgánom, predtým než (i) je takýto účastník skúšania zaradený do skúšania a (ii) sa spracujú akékoľvek osobné údaje takéhoto účastníka skúšania.
Sample 1
Informovaný súhlas. Institution acknowledges that Investigator shall use an informed consent form that has been approved by Sponsor and is in accordance with applicable regulations and the requirements of the Independent Ethics Committee (“IEC”) that is responsible for reviewing the Study. Zdravotnícke zariadenie potvrdzuje, že skúšajúci použije dokument informovaného súhlasu, ktorý bol schválený zadávateľom a spĺňa všetky platné nariadenia a požiadavky nezávislej etickej komisie, ktorá je zodpovedná za posúdenie skúšania.
Sample 1

Related to Informovaný súhlas

  • Důvěrné informace V průběhu klinického hodnocení mohou zdravotnické zařízení a hlavní zkoušející získávat nebo vytvářet informace, které jsou důvěrnými informacemi zadavatele nebo jeho přidružené strany.

  • Investigatory Interview When the employee under investigation is to be interviewed concerning the alleged conduct which could result in discharge or other discipline, the employee and his or her representative shall be notified in writing, at least forty-eight (48) hours prior to the interview. In the event of an emergency, such reasonable notice as the circumstances permit shall be given. The notice shall state that an official investigation is being conducted and shall state the subject matter of the investigatory interview. a. Prior to being interviewed pursuant to this section, the employee shall be afforded a reasonable opportunity and facilities to contact and consult privately with his or her union representative or union attorney. b. Any interview of an employee under this section shall be conducted at a reasonable time, at a suitable location and, when practicable, on the department’s premises when the employee is on duty. The union representative or union attorney may participate in the interview. c. The interview shall be limited to questions that are directly, narrowly, and specifically related to the employee’s job performance as it relates to the allegation(s) or complaints. The employee shall not be subjected to any offensive language nor be threatened with transfer, dismissal or other disciplinary action. Confidentiality of the interview shall be maintained.

  • Investigatory Interviews ‌ A. Upon request, an employee has the right to a union representative at an investigatory interview called by the Employer, if the employee reasonably believes discipline could result. An employee may also have a union representative at a pre-disciplinary meeting. If the requested representative is not reasonably available, the employee will select another representative who is available. Employees seeking representation are responsible for contacting their representative.

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

  • Information/Cooperation Executive shall, upon reasonable notice, furnish such information and assistance to the Bank as may be reasonably required by the Bank, in connection with any litigation in which it or any of its subsidiaries or affiliates is, or may become, a party; provided, however, that Executive shall not be required to provide information or assistance with respect to any litigation between Executive and the Bank or any other subsidiaries or affiliates.

  • Information Management Information and Records

  • Complaints Investigation The employee who complains of harassment under the provisions of the Human Rights Code must first comply with the Employer’s harassment policy procedures before filing a grievance or human rights complaint.

  • Geotechnical Investigation Perform in accordance with the City Design Manual and other City requirements as designated in writing by the Director.

  • Submitting Investigator An investigator who submitted a genomic dataset to an NIH designated data repository (e.g., dbGaP).

  • Investigational Services This plan covers certain experimental or investigational services as described in this section. This plan covers clinical trials as required under R.I. General Law § 27-20-60. An approved clinical trial is a phase I, phase II, phase III, or phase IV clinical trial that is being performed to prevent, detect or treat cancer or a life-threatening disease or condition. In order to qualify, the clinical trial must be: • federally funded; • conducted under an investigational new drug application reviewed by the Food and Drug Administration (FDA); or • a drug trial that is exempt from having such an investigational new drug application. To qualify to participate in a clinical trial: • you must be determined to be eligible, according to the trial protocol; • a network provider must have concluded that your participation would be appropriate; and • medical and scientific information must have been provided establishing that your participation in the clinical trial would be appropriate. If a network provider is participating in a clinical trial, and the trial is being conducted in the state in which you reside, you may be required to participate in the trial through the network provider. Coverage under this plan includes routine patient costs for covered healthcare services furnished in connection with participation in a clinical trial. The amount you pay is based on the type of service you receive. Coverage for clinical trials does not include: • the investigational item, device, or service itself; • items or services provided solely to satisfy data collection and that are not used in the direct clinical management; or • a service that is clearly inconsistent with widely accepted standards of care.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!