Clinical Research Site(s) definition

Clinical Research Site(s) means the site(s) at which the Protocol(s) described in the Research Plan will be performed.
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Clinical Research Site(s) means the site(s) at which the applicable Protocol will be performed.
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Clinical Research Site(s) means the participating clinical research sites where the Clinical Trial will be conducted in strict accordance with the Protocol. Other clinical sites or sub-sites may be added as necessary in order to complete the Protocol. In such a case, the Protocol will be amended to include the additional sites. Pursuant to their contract/grant, each Clinical Research Site will be responsible for the data, and scientific reporting of all results/data obtained from the Clinical Trial at the Investigator’s Clinical Research Site.
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Examples of Clinical Research Site(s) in a sentence

  • The Division of AIDS (DAIDS) policies on Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials and Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials are useful for interpreting and operationalizing the regulations and guidelines in accordance with DAIDS expectations.

  • All DAIDS policies referenced in this section are available at: https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures Study sites must comply with DAIDS policies on Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials and Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials.

  • Each of the organizational units that comprise MTN and each of the Clinical Trials Units (CTU) and Clinical Research Sites (CRS) affiliated with it must adhere to all relevant U.S. federal regulations and U.S. NIH/NIAID/DAIDS policies and procedures as a condition of receiving NIH funding.

  • The MWCCS Executive Committee has executed a master Data Use Agreement (mDUA) governing the sharing of data amongst all MWCCS Clinical Research Sites (CRS) and the DACC.

  • Copies of these regulations and guidelines are referenced in the MTN Manual of Operations (MOP) which can be accessed at: http://www.mtnstopshiv.org/node/187 The DAIDS policies on Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials and Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials are useful for interpreting and operationalizing the regulations and guidelines in accordance with DAIDS expectations.

  • Per the DAIDS policy on Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials, study sites are required to document screening (including screening failures) and enrollment activity on screening and enrollment logs.

  • Study sites must comply with DAIDS policies on Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials and Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials.

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  • Copies of these regulations and guidelines are referenced in the MTN Manual of Operations (MOP) which can be accessed at: http://www.mtnstopshiv.org/node/187The DAIDS policies on Requirements for Source Documentation in DAIDS Funded and/or Sponsored Clinical Trials and Requirements for Essential Documents at Clinical Research Sites Conducting DAIDS Funded and/or Sponsored Clinical Trials are useful for interpreting and operationalizing the regulations and guidelines in accordance with DAIDS expectations.

  • All protocol deviations should be adequately documented in study records consistent with DAIDS SOPs for Essential Documents at Clinical Research Sites.


More Definitions of Clinical Research Site(s)

Clinical Research Site(s) means the site(s) at which the Protocol(s) described in the Research Plan will be performed. [*****] Raptor Pharmaceutical Corp. has requested confidential treatment of certain portions of this offer letter which have been omitted and filed separately with the U.S. Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934.
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Clinical Research Site(s) means the clinical research site(s) including its subcontractors and its Investigators where the Clinical Trial will be conducted in strict accordance with the Protocol. The clinical research site(s) conduct clinical (vaccine/drug) research/trials at academic sites for [Insert Division], NIAID under a US federal government funded [Contract/Grant/Cooperative Agreement]. Clinical research sites may be changed or other clinical sites or subsites may be added as necessary in order to complete the Protocol. In such a case, the [Protocol or IND] will be amended to include these changes. Each clinical research site will be responsible for the data and scientific reporting of all results/data obtained from the Clinical Trial at that clinical research site. [OPTION: Add Appendix to list sites.]
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Clinical Research Site(s) means the clinical research site(s) including its subcontractors and its Investigators where the Clinical Trial will be conducted in strict accordance with the Protocol. Clinical Research Sites may be changed, or other Clinical Research Sites or subsites may be added as necessary in order to complete the Protocol. Each Clinical Research Site will be responsible for the data and scientific reporting of all results/data obtained from the Clinical Trial at that Clinical Research Site. Each Clinical Research Site is sponsored and funded by NIAID in accordance to the terms of that Clinical Research Site’s respective Award
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Related to Clinical Research Site(s)

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Clinical record means a legible electronic or hard-copy history that documents the criteria established for medical records as set forth in rule 441—79.3(249A). A claim form or billing statement does not constitute a clinical record.

  • Public research university means Rutgers, The State University

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Research facility means buildings and structures, including machinery and equipment, used or to be used primarily for research or experimentation to improve or develop new tangible goods or materials or to improve or develop the production processes thereto.