APPROVAL OF THE CLINICAL STUDY PROTOCOL AND AMENDMENTS Sample Clauses

APPROVAL OF THE CLINICAL STUDY PROTOCOL AND AMENDMENTS. Before the start of the study, the study protocol, informed consent document, and any other appropriate documents will be submitted to the IRB with a cover letter or a form listing the documents submitted, their dates of issue, and the site (or region or area of jurisdiction, as applicable) for which approval is sought. If applicable, the documents will also be submitted to the authorities in accordance with local legal requirements. Sobi AG can initiate the NI-0501-05 study at any site which has already participated in a previous NI- 0501 clinical trial or a CU treatment protocol, as soon as Sobi AG, or their authorized representative, has received documentation on all ethical and legal requirements for starting the study at this site. Sobi AG can only supply NI-0501 to an Investigator of an initiated site and for patients requiring, as per the treating physician’s request, to continue receiving NI-0501 beyond the 8-week treatment in study NI-0501-04. This documentation must also include a list of the members of the IRB and their occupations and qualifications. If the IRB will not disclose the names of the committee members, it should be asked to issue a statement confirming that the composition of the committee is in accordance with GCP. Formal approval by the IRB should preferably mention the study title, study code, study site, and any other documents reviewed. It must mention the date on which the decision was made and must be officially signed by a committee member (chairman or secretary of the IRB). Before the first patient is enrolled in the study, all ethical and legal requirements must be met. The IRB and, if applicable, the authorities, must be informed of all subsequent protocol amendments in accordance with local legal requirements. Amendments must be evaluated to determine whether formal approval must be sought and whether the informed consent document should also be revised. The Investigator must keep a record of all communication with the IRB and, if applicable, between a coordinating Investigator and the IRB. This statement also applies to any communication between the Investigator (or coordinating Investigator, if applicable) and regulatory authorities. Before any documents are given to patients or their legal representative, they must first be reviewed and approved by Sobi AG, and upon approval by Sobi AG, submitted to and reviewed and approved by the competent IRB. These include but are not limited to the informed consent form, patient ...
Sample 1
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APPROVAL OF THE CLINICAL STUDY PROTOCOL AND AMENDMENTS. Before the start of the study, the study protocol, informed consent document, and any other appropriate documents will be submitted to the IEC with a cover letter or a form listing the documents submitted, their dates of issue, and the site (or region or area of jurisdiction, as applicable) for which approval is sought. If applicable, the documents will also be submitted to the authorities in accordance with local legal requirements. NovImmune can only supply study drug to an Investigator after NovImmune or their authorised representative, an international CRO, has received documentation on all ethical and legal requirements for starting the study. This documentation must also include a list of the members of the IEC and their occupation and qualifications. If the IEC will not disclose the names of the committee members, it should be asked to issue a statement confirming that the composition of the committee is in accordance with GCP. Formal approval by the IEC should preferably mention the study title, study code, study site, and any other documents reviewed. It must mention the date on which the decision was made and must be officially signed by a committee member (chairman or secretary of the IEC. Before the first patient is enrolled in the study, all ethical and legal requirements must be met. The IEC and, if applicable, the authorities, must be informed of all subsequent protocol amendments in accordance with local legal requirements. Amendments must be evaluated to determine whether formal approval must be sought and whether the informed consent document should also be revised. The Investigator must keep a record of all communication with the IEC and, if applicable, between a coordinating Investigator and the IEC. This statement also applies to any communication between the Investigator (or coordinating Investigator, if applicable) and regulatory authorities. All documents handed over to patients or their legal representative prior to use must first be reviewed and approved by NovImmune, and upon approval by NovImmune submitted to and reviewed and approved by, the competent IEC. This includes but is not limited to the informed consent form, patient information sheet, assent form, advertisements, training materials, etc.
Sample 1

Related to APPROVAL OF THE CLINICAL STUDY PROTOCOL AND AMENDMENTS

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials 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 Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical 2.1 Provides comprehensive evidence based nursing care to patients including assessment, intervention and evaluation.

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  • COVID-19 Protocols Contractor will abide by all applicable COVID-19 protocols set forth in the District’s Reopening and COVID-19 Mitigation Plan and the safety guidelines for COVID-19 prevention established by the California Department of Public Health and the Ventura County Department of Public Health.

  • How to File an Appeal of a Prescription Drug Denial For denials of a prescription drug claim based on our determination that the service was not medically necessary or appropriate, or that the service was experimental or investigational, you may request an appeal without first submitting a request for reconsideration. You or your physician may file a written or verbal prescription drug appeal with our pharmacy benefits manager (PBM). The prescription drug appeal must be submitted to us within one hundred and eighty (180) calendar days of the initial determination letter. You will receive written notification of our determination within thirty (30) calendar days from the receipt of your appeal. How to File an Expedited Appeal Your appeal may require immediate action if a delay in treatment could seriously jeopardize your health or your ability to regain maximum function, or would cause you severe pain. To request an expedited appeal of a denial related to services that have not yet been rendered (a preauthorization review) or for on-going services (a concurrent review), you or your healthcare provider should call: • our Grievance and Appeals Unit; or • our pharmacy benefits manager for a prescription drug appeal. Please see Section 9 for contact information. You will be notified of our decision no later than seventy-two (72) hours after our receipt of the request. You may not request an expedited review of covered healthcare services already received.

  • State Approval of Replacement Personnel The Engineer may not replace the project manager or key personnel without prior consent of the State. The State must be satisfied that the new project manager or other key personnel is qualified to provide the authorized services. If the State determines that the new project manager or key personnel is not acceptable, the Engineer may not use that person in that capacity and shall replace him or her with one satisfactory to the State within forty-five (45) days.

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  • Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.

  • APPROVAL OF GENERAL COMMUNICATIONS Competitive Supplier may only communicate with Program participants and/or use the lists of Eligible Consumers/Program participants to send Department-approved education materials, opt- out notices, or other communications essential to the operation of the Program. Such lists may not be used by Competitive Supplier to market any additional products or services to Eligible Consumers or Program Participants. Competitive Supplier shall cooperate with and assist the Town in the drafting and sending of messages and information to Eligible Consumers concerning the Program or any matter arising under or related to this Agreement or the Program. Competitive Supplier shall, prior to sending any direct mail, advertising, solicitation, bill insert, electronic mail, or other similar written or electronic communication (collectively, “General Communications”) to Participating Consumers (but excluding individually drafted or tailored communications responding to a specific complaint or communication of an individual consumer), provide a copy of such General Communication to the Town for its review (for consistency with the Town’s purposes and goals) and approval. The Town shall have the right to disapprove such General Communications and suggest revisions if it finds the communication inconsistent with the purposes and goals of the Town, factually inaccurate, not essential to the operation of the program, or likely to mislead provided, however, that: (i) the communication shall be deemed approved if the Town fails to respond within ten (10) Business Days, and (ii) no approval shall be necessary for any communication (a) regarding any emergency situation involving any risk to the public health, safety or welfare; (b) that has been approved by the Department, the DOER; or (c) in the nature of routine monthly or periodic bills, or collection notices, except that any bill insert or message included at the bottom of such bill not within the scope of (a) or (b) above shall require advanced review and approval by the Town; and (iii) no approval or lack of approval shall relieve the Competitive Supplier of its obligations and responsibility for its actions and omissions under this Agreement, or other than as set forth in sub-clause ‘i’ of this Section 7.6, result in a waiver of any rights, remedies or defenses of the Town. The Town may reject or exclude any proposed General Communication that, in its reasonable judgment, is contrary to the interests and objectives of the Program or the Town.

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