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

  • Required Documentation The Company must have delivered to the Investor copies of all resolutions duly adopted by the Board of Directors of the Company, or any such other documentation of the Company approving the Agreement, the Transaction Documents and any of the transactions contemplated hereby or thereby;

  • Regulatory Documentation Avidity and its Affiliates have generated, prepared, maintained and retained all Regulatory Documentation that is required to be maintained or retained pursuant to and in accordance with, to the extent applicable, good laboratory and clinical practice and Applicable Law and all such information is true, complete and correct in all material respects and what it purports to be. “Regulatory Documentation” means all: (a) applications (including all INDs and applications for Regulatory Approval), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all adverse event files and complaint files; (c) supplements or changes to any of the foregoing following Regulatory Approval; and (d) clinical and other data, including Clinical Trial data, contained or relied upon in any of the foregoing; in each case ((a), (b), (c) and (d)) relating to a Collaboration Target and Compounds Directed Against a Collaboration Target.

  • Appropriate Documentation The Company will have received, in a form and substance reasonably satisfactory to Company, dated the Closing Date, all certificates and other documents, instruments and writings to evidence the fulfillment of the conditions set forth in this Article 6 as the Company may reasonably request.

  • Technical Documentation Subject to the terms of this Agreement, BROCADE hereby grants to McDATA a nonexclusive, nontransferable, worldwide license to reproduce and use BROCADE's technical documentation provided to McDATA by BROCADE hereunder, solely for McDATA's internal purposes in connection with the manufacture, marketing and support of the McDATA Products into which the Products are incorporated as set forth herein. Modifications to such technical documentation by McDATA shall require BROCADE's prior written authorization, which authorization will not be unreasonably withheld.

  • Closing Documentation The Buyer shall have received the following documents, agreements and instruments from the Seller:

  • Approval of Documentation The form and substance of all certificates, instruments 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.

  • Review of Documentation The Depositor, by execution and delivery hereof, acknowledges receipt of the Mortgage Files pertaining to the Mortgage Loans listed on the Mortgage Loan Schedule, subject to review thereof by Xxxxx Fargo Bank National Association, LaSalle Bank National Association, Deutsche Bank National Trust Company and U.S. Bank National Association as applicable (each, a “Custodian” and, together, the “Custodians”), for the Depositor. Each Custodian is required to review, within 45 days following the Closing Date, each applicable Mortgage File. If in the course of such review the related Custodian identifies any Material Defect, the Seller shall be obligated to cure such Material Defect or to repurchase the related Mortgage Loan from the Depositor (or, at the direction of and on behalf of the Depositor, from the Trust Fund), or to substitute a Qualifying Substitute Mortgage Loan therefor, in each case to the same extent and in the same manner as the Depositor is obligated to the Trustee and the Trust Fund under Section 2.02(c) of the Trust Agreement.

  • Product Documentation Supplier shall produce and deliver to Sony Ericsson Product Documentation fulfilling the requirements set out in templates included in Enclosure 2.3.

  • Additional Documentation Execute and deliver, or cause to be executed and delivered, any and all other agreements, instruments or documents which Lender may reasonably request in order to give effect to the transactions contemplated under this Loan Agreement and the other Loan Documents.

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