Required Prestudy Documentation Sample Clauses

Required Prestudy Documentation. The following documents must be provided to the sponsor before shipment of study drug to the investigational site: ● Protocol and amendment(s), if any, signed and dated by the investigator. ● A copy of the dated and signed written IEC/IRB approval of the protocol, amendments, informed consent form, any recruiting materials, and if applicable, subject compensation programs. This approval must clearly identify the specific protocol by title and number and must be signed by the chairman or authorized designee. ● Name and address of the IEC/IRB including a current list of the IEC/IRB members and their function, with a statement that it is organized and operates according to GCP and the applicable laws and regulations. If accompanied by a letter of explanation from the IEC/IRB, a general statement may be substituted for this list. If an investigator or a member of the investigational staff is a member of the IEC/IRB, documentation must be obtained to state that this person did not participate in the deliberations or in the vote/opinion of the study. ● Regulatory authority approval or notification, if applicable. ● Signed and dated statement of investigator (e.g., Form FDA 1572), if applicable ● Documentation of investigator qualifications (e.g., curriculum vitae). ● Completed investigator financial disclosure form from the investigator. ● Signed and dated clinical trial agreement, which includes the financial agreement. ● Any other documentation required by local regulations. The following documents must be provided to the sponsor before enrollment of the first subject: ● Completed investigator financial disclosure forms from all subinvestigators. ● Documentation of subinvestigator qualifications (e.g., curriculum vitae). ● Name and address of any local laboratory conducting tests for the study, and a dated copy of current laboratory normal ranges for these tests. ● Local laboratory documentation demonstrating competence and test reliability (e.g., accreditation/license), if applicable. The following document must also be provided to the sponsor: ● Photocopy of the site signature log, describing delegation of roles and responsibilities at the start of the study.
Sample 1
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Related to Required Prestudy Documentation

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  • Project Documentation All documentation provided to the City other than Project drawings shall be furnished on a Microsoft compatible compact disc.

  • Licensed Documentation If commercially available, Licensee shall have the option to require the Contractor to deliver, at Contractor’s expense: (i) one (1) hard copy and one (1) master electronic copy of the Documentation in a mutually agreeable format; (ii) based on hard copy instructions for access by downloading from the Internet

  • Technical Documentation Prior to commencement of the Tests on Completion, the Contractor shall supply to the Engineer the technical documentation as specified in the Employer’s Requirements. The Works or Section shall not be considered to be completed for the purposes of taking- over under sub-clause 10.1 [Taking Over of the Works and Sections] until the Engineer has received the technical documentation as defined in this sub-clause 5.7, the "history file" including design calculations and certain certification as well as any other documents required to meet the CE Marking requirements.

  • Closing Documentation The Parent shall have received the --------------------- following documents, agreements and instruments from the Company: (i) an opinion of Xxxx Xxxx Xxxx & Freidenrich LLP, dated the Closing Date and addressed to the Parent and Newco, in substantially the form of Exhibit F hereto; --------- (ii) certificates dated as of a recent date from the Secretary of State of the States of Delaware and any other applicable states to the effect that each of the Company and its Subsidiaries is duly incorporated and in good standing in such state and stating that the Company and its Subsidiaries owes no franchise taxes in such state and listing all documents of the Company and its Subsidiaries on file with said Secretary of State; (iii) a copy of the Certificate of Incorporation of the Company, including all amendments thereto, certified as of a recent date by the Secretary of State of the State of Delaware; (iv) evidence, reasonably satisfactory to the Parent, of the authority and incumbency of the persons acting on behalf of the Company in connection with the execution of any document delivered in connection with this Agreement; (v) Uniform Commercial Code Search Reports on Form UCC-11 with respect to the Company and its Subsidiaries from the states and local jurisdictions where the principal place of business of the Company and its Subsidiaries and their respective assets are located, the search reports of which shall confirm compliance with Section 3.15 (and Schedule thereto) of this Agreement; (vi) the corporate minute books and stock record books of the Company and its Subsidiaries; (vii) estoppel letters of lenders to the Company, in form and substance reasonably satisfactory to the Parent, with respect to amounts (including any pre-payment penalties) owing by the Company as of the Closing; and (viii) such other instruments and documents as the Parent shall reasonably request not inconsistent with the provisions hereof.

  • Approval of Documentation The form and substance of all certificates, instruments, opinions, and other documents delivered to Buyer under this Agreement shall be satisfactory in all reasonable respects to Buyer and its counsel.

  • Closing Documentation, etc For purposes of determining compliance with the conditions set forth in §12, each Lender that has executed this Credit Agreement shall be deemed to have consented to, approved or accepted, or to be satisfied with, each document and matter either sent, or made available, by any Agent or any Co-Lead Arranger to such Lender for consent, approval, acceptance or satisfaction, or required thereunder to be consented to or approved by or acceptable or satisfactory to such Lender, unless an officer of the Administrative Agent active upon the Borrowers’ account shall have received notice from such Lender prior to the Closing Date specifying such Lender’s objection thereto and such objection shall not have been withdrawn by notice to the Administrative Agent to such effect on or prior to the Closing Date.

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