Investigator Responsibilities and Requirements Sample Clauses

Investigator Responsibilities and Requirements. ‌ By agreeing to participate in this clinical trial, the Principal Investigator and all subinvestigators agree to perform the study in accordance with all stipulations of the protocol, the FDA Code of Federal Regulations (21 CFR Parts 11, 50, 54, 56 and 312), applicable local regulation(s) and ICH Guidelines for GCP (E6). Prior to initiation of the study the Principal Investigator must, at minimum, provide VentiRx or its representative with the following documentation: • Signed clinical trial agreement • Signed Principal Investigator Protocol Agreement • Signed FDA Form 1572 or equivalentCurriculum Vitae of the Principal Investigator • Current medical license(s) for the Principal Investigator • Copy of written IRB/IEC approval for the study and informed consent formFinancial disclosure for the Principal Investigator The Principal Investigator is responsible for complying with all commitments as delineated in Box 9 of FDA form 1572 and/or local regulations.
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Related to Investigator Responsibilities and Requirements

  • Contractor Responsibilities 19.1. Contractor shall perform national criminal history checks for Ohio, Indiana, and Kentucky, and 10-panel drug screening tests on all prospective employees performing work under this RFP or coming onto a CMHA property and any resulting contract and provide summaries of the results to the Authority if requested. For the purposes of this section, the term “employees” includes contractor. Prospective employees whose criminal background check discloses a misdemeanor or felony involving crimes of moral turpitude, sexual offenses or harm to persons or property shall not be employed to perform work under this RFP or any resulting contract. Contractor is required to perform drug screening of all employees and to ensure acceptable test results. Criminal history and drug screening checks will be completed at the sole expense of the contractor. Any employee of the Contractor suspected of being under the influence of drugs and or alcohol will be reported to the appropriate personnel at CMHA and/or other local law enforcement. If the employee is determined to be under the influence of drugs or alcohol in any form or manner, or believed by proper authority to be dealing in illicit sale of alcohol or drugs they will be removed and shall not be allowed to return to any job site on the Authority’s property. The Contractor’s contract may be suspended and/or terminated should such a situation occur or if the Contractor fails to submit results pursuant to this section.

  • PRIME CONTRACTOR RESPONSIBILITIES A. The Contractor shall be responsible for completely supervising and directing the work under this Contract and all Subcontractor(s) that it may utilize, using adequate skill and attention. Subcontractor(s) who perform work under this Contract shall be responsible to the Prime Contractor.

  • Faculty Responsibilities The principles of academic freedom shall be accompanied by corresponding principles of Faculty responsibility. While workload and additional Faculty responsibilities may be provided for elsewhere in this Agreement, the following are among the basic responsibilities of the Faculty:

  • Company Responsibilities The Company will undertake responsibilities as set forth below:

  • SAFETY RESPONSIBILITIES Contractor will adhere to all applicable CalOSHA requirements in performing work pursuant to this Agreement. Contractor agrees that in the performance of work under this Agreement, Contractor will provide for the safety needs of its employees and will be responsible for maintaining the standards necessary to minimize health and safety hazards.

  • Vendor Responsibilities Note: NO EXCEPTIONS OR REVISIONS WILL BE CONSIDERED IN C-M, O-S, V-W. Indemnification

  • KEY RESPONSIBILITIES The following objects of local government will inform Employee’s performance against set performance indicators:

  • ADDITIONAL CONTRACTOR RESPONSIBILITIES 13 In addition to providing the services described in Paragraph 5 of this 14 Exhibit A, CONTRACTOR agrees to:

  • Our Responsibilities This notice describes how medical information about you may be used and disclosed and how you can get access to this information. Please review it carefully. This notice took effect on September 23, 2013. We are required to maintain the privacy of your protected health information and we will follow the terms of this notice while it is in effect. Your Protected Health Information (PHI) and Other Nonpublic Personal Information PHI — health information that identifies you or could be used to identify you that was created or received by a provider, health plan, or employer, and that relates to one of the following: • Your past, present, or future physical or mental health or condition • Providing you health care • The past, present, or future payment for providing you health care Other Nonpublic Personal Information — identifies you, such as account balance information, payment history, information obtained in connection with a loan, or information from a consumer report. Your Information We collect your information as necessary to provide you with health insurance products and services and to administer our business. We may also disclose this information to nonaffiliated third parties as described in this notice. The types of information we may collect and disclose include: • Information you or your employer provide on applications and other forms, such as names, addresses, social security numbers, and dates of birth • Information about your interactions with us or others (such as providers) regarding your medical information or claims • Information you provide in person, by phone, in email, or through visits to our website Your Rights When it comes to your health information, you have certain rights. This section explains your rights and some of our responsibilities. Get a copy of health and claims records • You can ask to see or get a copy of your health and claims records and other health information we have about you. • We will provide a copy or a summary of your health and claims records, usually within 30 days of your request. We may charge a reasonable, cost-based fee. • We may ask that you submit your request in writing. Please note, if you want to obtain copies of your medical records, you should contact the practitioner or facility. We do not generate, modify, or maintain complete medical records. • You may also request that we send a copy of your information to a third party. We may ask that you submit a written, signed authorization form permitting us to do so and we may charge a reasonable fee for copying and mailing your personal information. Ask us to correct health and claims records • You can ask us to correct your health and claims records if you think they are incorrect or incomplete. • We may say no to your request, but we’ll tell you why in writing within 60 days. Request confidential communications • You can ask us to contact you in a specific way (for example, home or office phone) or to send mail to a different address. • We will consider all reasonable requests, and must say “yes” if you tell us you would be in danger if we do not. • All requests should be made in writing. • It may take a short period of time for us to implement your request. • We will comply with your request if it is reasonable and continues to permit us to collect premiums and pay claims under your policy, including issuing certain explanations of benefits and policy information to the BlueShield of Northeastern New York is a division of HealthNow New York Inc., an independent licensee of the BlueCross BlueShield Association. 15049R_NENY_12_19 f11011 subscriber of the policy. For example, even if you request confidential communications: ο We will mail the check for services you receive from a nonparticipating provider to you but made payable to the subscriber ο Accumulated payment information such as deductibles (in which your information might appear), will continue to appear on explanations of benefits sent to the subscriber ο We may disclose to the subscriber, as the contract holder, policy details such as eligibility status or certificates of coverage Ask us to limit what we use or share • You can ask us not to use or share certain health information for treatment, payment, or our operations. • We are not required to agree to your request, but if we do, we will abide by our agreement (except when necessary for treatment in an emergency). You have the right to request a list of certain disclosures of your information we or our business associates made for purposes other than treatment, payment, or health care operations. You have the right to receive a paper copy of this notice Choose someone to act for you • You have the right to authorize individuals to act on your behalf with respect to your information. You must identify your authorized representatives on a HIPAA-compliant authorization form (available on our website) and explain what type of information they may receive. • You have the right to revoke an authorization except for actions already taken based on your authorization. File a complaint if you feel your rights are violated • You can complain if you feel we have violated your rights by contacting us using the information listed on page 4. • You can file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights. • We will not retaliate against you for filing a complaint. Your Choices For certain health information, you can tell us your choices about what we share. We may use and disclose your information in the situations described below but you have the right to limit or object to these uses or disclosures. If you have a clear preference for how we share your information in these situations, contact us using the information on page 4. • With your family, close friends, or others involved with your health care or payment for your care when you are present and have given us permission to do so. If you are not present, if it is an emergency, or you are not able to give us permission, we may give your information to a family member, friend, or other person if sharing your information is in your best interest. In these cases, the person requesting your information must accurately verify details about you (e.g., name, identification number, date of birth, etc.) and prove involvement with your health care or payment for your health care by providing details relevant to the information requested. For example, if a family member calls us with prior knowledge of a claim (e.g., provider’s name, date of service, etc.), we may confirm the claim’s status, patient responsibility, etc. We will only disclose information directly relevant to that person’s involvement with your health care or payment for your health care. • In a disaster relief situation. Uses and disclosures for which we will obtain your authorization In these cases we never share your information unless you give us written permission: • Marketing purposes • Sale of your information • Disclose your psychotherapy notes • Make certain disclosures of information considered sensitive in nature, such as HIV/AIDS, mental health, alcohol or drug dependency, and sexually transmitted diseases. Certain federal and state laws require that we limit how we disclose this information. In general, unless we obtain your written authorization, we will only disclose such information as provided for in applicable laws. Our Uses and Disclosures How do we typically use or share your health information? We typically use or share your health information in the following ways: Help manage the health care treatment you receive • We can use your health information and share it with professionals who are treating you.

  • Reporting Responsibilities The IRA Owner agrees to provide the Custodian with information necessary for the Custodian to prepare any reports required under Code Sections 408(i), 408A(d)(3)(D), and Regulations Sections 1.408-5 and 1.408-6. The Custodian agrees to submit reports to the IRS and the IRA Owner (or Beneficiary(ies) upon the IRA Owner’s death) as prescribed by the IRS and such additional reports as the Custodian may choose to deliver. The Custodian shall furnish annual calendar-year reports concerning the status of the IRA and such information concerning required minimum distributions as is prescribed by the Commissioner of the IRS.

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