Inclusion of Women and Minorities Sample Clauses

Inclusion of Women and Minorities. This program has a prospective component in that it will recruit children from four elementary schools and four middle schools, across four parishes in Louisiana. The children will be assessed at the beginning of the program during the telehealth consultation, and re-evaluated nine months after the initial telehealth consultation. It is anticipated that the number of female and male participants recruited will be approximately the same. There are no inclusion or exclusion criteria based on sex or race. Program enrollment will occur at selected schools that have a population reflective of the diversity of the general population of their respective city/parish, and are demonstrated in our expected enrollment table.
Sample 1
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Inclusion of Women and Minorities. This program has a prospective component in that it will recruit children from four elementary schools and four middle schools, across four parishes in Louisiana. The children will be assessed at the beginning of the program during the telehealth consultation, and re-evaluated nine months after the initial telehealth consultation. It is anticipated that the number of female and male participants recruited will be approximately the same. There are no inclusion or exclusion criteria based on sex or race. Program enrollment will occur at selected schools that have a population reflective of the diversity of the general population of their respective city/parish, and are demonstrated in our expected enrollment table. Potential Risks: Confidentiality: Certain aspects of the subjects’ medical history and demographics will be collected for this study. Loss of privacy may lead to problems with insurability or social stigmatization. Also, some of the results from the physical assessment and pulmonary function test being performed may potentially indicate other health conditions. Loss of privacy, in regard to this information, may also lead to problems with insurability. Adequacy of protection against risks: Children will be recruited from the participating elementary and middle schools. Pre-registration in the program by the parent is required. Families who participated in this study were first screened for eligibility. Consent and assent forms will be signed and returned to the designated school-based telehealth site. Children will then be scheduled for an appointment through the school nurse and administrative offices. Parents and guardians will be asked by the school nurse/school administrative staff if they would like to speak with a member of the Breathe Easy staff regarding this program. If they agree, the program manager will be available to discuss the details of the program. All information will be explained in a nontechnical fashion. Ample time will be available for the child’s parent/guardian to ask any specific questions or discuss any specific concerns about the program. Parents will be informed of the risks associated with the loss of confidentiality of collected information. Since there may be Spanish-monolingual children who attend one of the participating schools, the program staff will contact the AT&T language line during the consent process and schedule a Spanish-interpreter to be present during the telehealth visits. Consent forms will be trans...
Sample 1
Inclusion of Women and Minorities. Targeted enrollment of women and minorities is based on a combination of EACH Center demographics (53% female, 66% white, 16.4% black, 1.1% Hispanic or Latino, 0.4% Asian, 11.1% unrecorded, and 5.4% other/declined) and the congenital heart defects birth rate demographics in the metropolitan Atlanta area (50.2% female, 52.1% white, 36.0% black, and 11.9% other).94 Thus, the targeted enrollment for this study includes 50% female, 66% white, 26% black, 8% other, and 3% Hispanic or Latino. Gender, race, and ethnicity were monitored and recruitment strategies would be altered to ensure adequate representation of women and minorities.
Sample 1
Inclusion of Women and Minorities. All genders and racial/ethnic groups will be eligible for this study. Chapter IV-Incorporation of Reviewer Comments Thank you for agreeing to participate in the Assessment of Complementary Alternative Medicine Therapies Being Utilized by Cancer Patients at the End of Life and Communication of CAM Usage Between Patients and Physicians review. Your written review is critical as your comments provide substance as to the project and its strengths and weaknesses with respect to each evaluation criteria. Reviewer 1 comments
Sample 1
Inclusion of Women and Minorities. The study is open to anyone regardless of gender or ethnicity. Efforts will be made to extend the accrual to a representative population, but in a trial which will accrue approximately 18 subjects, a balance must be struck between subject safety considerations and limitations on the number of individuals exposed to potentially toxic or ineffective treatments on the one hand and the need to explore gender, racial, and ethnic aspects of clinical research on the other. If differences in outcome that correlate to gender, racial, or ethnic identity are noted, future studies may explore those differences.
Sample 1

Related to Inclusion of Women and Minorities

  • Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Services and Exclusivity of Services The Company and Executive ------------------------------------ recognize that the services to be rendered by Executive are of such a nature as to be peculiarly rendered by Executive, encompass the individual ability, managerial skills and business experience of Executive and cannot be measured exclusively in terms of hours or services rendered in any particular period. Executive agrees to devote Executive's full business time and to use Executive's best efforts, energy and ability exclusively toward advancing the business, affairs and interests of the Company, and matters related thereto.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Technical Services Party B will provide technical services and training to Party A, taking advantage of Party B’s advanced network, website and multimedia technologies to improve Party A’s system integration. Such technical services shall include:

  • Development of Products (a) During the term of this Agreement, ViewRay may from time to time seek services from PEKO with respect to the development of certain Products that can be incorporated into the ViewRay Renaissance™ MRI-guided radiation therapy system. For each Program to be undertaken by PEKO pursuant to this Agreement, the parties will prepare a “Work Statement” and agree to said “Work Statement” in substantially the form attached as Attachment 1. Each Work Statement will describe: (i) the (i) services that PEKO will be responsible for providing to ViewRay and the deliverables that PEKO will be responsible for delivering to ViewRay (“Deliverable(s)”), (ii) delivery schedule for the Deliverables, (iii) pricing terms, (iv) work plan for the Program, and (v) ViewRay’s responsibilities in connection with the Program. Each Work Statement will be prepared based upon the requirements and information provided to PEKO by ViewRay. A separate Work Statement will be required for each Program; and each Work Statement will become subject to this Agreement only when mutually agreed and signed by ViewRay and PEKO.

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement, the Pricing Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with applicable laws, rules, regulations and policies of the Food and Drug Administration of the U.S. Department of Health and Human Services (the “FDA”) or any committee thereof or of any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are materially inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Pricing Disclosure Package or the Prospectus; for such studies that have been or are being conducted, the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by foreign government or drug or medical device regulatory agencies, or foreign health care facility Institutional Review Boards; and no investigational new drug application filed by or on behalf of the Company or any of its subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing studies conducted or proposed to be conducted by or on behalf of the Company or any of its subsidiaries.

  • Clinical Data The descriptions of the results of any studies and tests conducted by or on behalf of, or sponsored by, the Company or its subsidiaries, or in which the Company has participated, that are described in the Disclosure Package and the Prospectus, or the results of which are referred to in the Disclosure Package and the Prospectus do not contain any misstatement of material fact or omit to state a material fact necessary to make such statements not misleading. The Company has no knowledge of any studies or tests not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Disclosure Package or Prospectus.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

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