Trials definition

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’.

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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 ▇▇▇▇▇▇▇ make no guarantee the data will meet researchers’ needs for analyses outlined in the Research Proposal.

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 ▇▇▇▇▇▇▇ & ▇▇▇▇▇▇▇ Family of Medical Device Companies, make no guarantee the data will meet researchers’ needs for analyses outlined in the Research Proposal.

Examples of Trials in a sentence

• Trials may be discontinued, modified, or cancelled by A10 for any reason upon thirty (30) days’ prior written notice without liability to A10.

• Citizens expects there will be only two attendees at Trial Preparation Sessions facilitated by Citizens and Trials, unless otherwise indicated by the Litigation Specialist.

• Licensee shall not conduct basic research or pre-clinical, clinical or other studies (including Clinical Trials, non-clinical toxicology studies or any other study in humans or animals) with the Compound or Licensed Product without Shionogi's prior written approval (which may be provided or withheld in Shionogi's sole discretion).

• To the extent an Order specifies that Client may offer Trials and Betas to Subscribers, Client assumes all liability related to such Trials or Betas offering.

• Royal Decree 1090/2015, 4th December, which approves the Regulations on Clinical Trials with medicinal products, medicinal Research Ethic Committees and the Spanish Register on clinical Trials (hereinafter RD 1090/2015) Royal legislative Decree 1/2015, 24th July, which approves the text of the Law of guarantees and rational use on the medicinal products Royal Decree 577/2013, 26 July, which regulates pharmacovigilance of medicinal products in human use.

More Definitions of Trials

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.

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 means clinical research studies of Investigational Products.

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

Trials means the clinical trials to establish the safety and efficacy of PAS required to get product approval for marketing a new drug in the US, EU and elsewhere;