Trials definition

Trials and "Tests" shall mean such trials and tests as are provided for in the conditions of contract and described in the specification and shall include all other tests to be carried out as per the requirement of the „Cochin Port Trust‟.

Trials are controlled, interventional clinical studies in patients of products that have been provided marketing authorization by both the Food and Drug Administration and the European Medicines Agency; “trials” do not include other studies such as phase 1 clinical investigations of drugs or biological products subject to Food and Drug Administration or European Medicines Agency regulations in healthy volunteers or pre-clinical studies. The Data to be provided is intended to be completely de- identified consistent with the HIPAA privacy standards for de-identification set forth at 45 CFR § 164.514. Such Data shall not be modified or redacted by Yale or Data User (except with regards to de-identification) and any attempts to identify patients or providers or to suggest the identity of patients or providers are prohibited by this Agreement. Yale and XXXXXXX make no guarantee the data will meet researchers’ needs for analyses outlined in the Research Proposal.

Trials and "Tests" shall mean such trials and tests as are provided for in these conditions of contract and described in the specification and shall include all other tests to be carried out as per the requirement of the ‘employer’. “Approved" or "Approval" shall mean approval in writing.

Examples of Trials in a sentence

• The IRBs of MGH and BWH registered with the Office for Human Research Protections (collectively known as the “Partners Human Research Committee” or “PHRC”) have been selected by the National Institute of Neurological Disorders and Stroke (“NINDS”) to serve as the central IRB (“Central IRB”) for the NINDS Network for Excellence in Neuroscience Clinical Trials (“NeuroNEXT”).

• At the end of such Trials, we may automatically start to charge you the applicable fees on the first day following the end of the Trial, on a recurring monthly basis.

• Informed Consent Form Formulář písemného informovaného souhlasu Site agrees to use an informed consent form that has been approved by Sponsor and is in accordance with applicable regulations and the requirements of the Ethics Committee for Multicentrics Trials (“ECMT”) and Local Ethics Committees (“LEC), jointly Ethics Committees (“EC”) that is responsible for reviewing the Study.

• It is the responsibility of the Sponsor to submit safety reports to the relevant Regulatory Authorities as applicable and in accordance with both the Note for Guidance on Planning Pharmacovigilance Activities (ICH E2E) and the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004 or the EU Clinical Trial Regulations, as applicable.

• For some Trials, we will require you to provide your payment details to start the Trial.

More Definitions of Trials

Trials are controlled, interventional clinical studies in patients of medical device or diagnostic products that have been provided any necessary authorization from 2014 going forward to allow the marketing of the product under both the United States and European Union medical device legislative frameworks. “Trials” do not include the following: (i) studies that were initiated prior to the effective date of the registration requirements for “applicable device clinical trials” under Title VIII of the Food and Drug Administration Act of 2007 (FDAAA); or (ii) studies that are not considered “applicable device clinical trials” under FDAAA, including but not limited to a small clinical trial to determine the feasibility of a device or a clinical trial to test prototype devices where the primary outcome measure relates to feasibility and not to health outcomes; or (iii) pre-clinical studies. The Data to be provided is intended to be completely de-identified consistent with the HIPAA privacy standards for de-identification set forth at 45 CFR § 164.514. Such Data shall not be modified or redacted by Yale or Data User (except with regards to de- identification) and any attempts to identify patients or providers or to suggest the identity of patients or providers are prohibited by this Agreement. Yale and MDDGS, acting on behalf of the Xxxxxxx & Xxxxxxx Family of Medical Device Companies, make no guarantee the data will meet researchers’ needs for analyses outlined in the Research Proposal.

Trials and "Tests" shall mean such trials and tests as are provided for in these

Trials means any and all trials carried out on Products or any of the raw materials set out in Schedule 2 by or for Phytopharm on human and/or animal subjects.

Trials means all comparative studies of health interventions, not just ones conducted in a clinical setting.

Trials. Has the meaning set out in Clause 7.1(a);

Trials and "Tests" shall mean such trials and tests as are provided for in these conditions of contract and described in the specification and shall include all other

Trials are controlled, interventional clinical studies in humans of consumer products that are regulated as medicinals or devices and have been authorized or cleared by the FDA and EMA or by a health authority anywhere in the world if FDA and EMA authorization or clearance are not required or sought to allow marketing in that region from 2014 going forward. “Trials” do not include other studies such as (but not limited to) consumer behavior/use studies, phase 1 clinical investigations of drugs or biological products or pre-clinical studies. Yale shall apprise CONSUMER of which clinical trials it determines are Trials and afford CONSUMER, a reasonable opportunity to advise Yale on its selection but Yale shall have the ultimate authority to determine which clinical trials are Trials.” The Data to be provided is intended to be completely de-identified consistent with the HIPAA privacy standards for de-identification set forth at 45 CFR § 164.514. Such Data shall not be modified or redacted by Yale or Data User (except with regards to de-identification) and any attempts to identify patients or providers or to suggest the identity of patients or providers are prohibited by this Agreement. Yale and CONSUMER make no guarantee the data will meet researchers’ needs for analyses outlined in the Research Proposal. 2.2