Essential Study Documents Sample Clauses

Essential Study Documents. The Investigator is responsible for providing and maintaining essential study documents. Essential study documents are those documents that individually and collectively permit the evaluation of the conduct of the study and the quality of the data produced. These documents serve to demonstrate the compliance of the Investigator and the Sponsor (or an authorized representative) with the standards of GCPs and with all applicable national regulatory requirements. Essential study documents will include regulatory documents as well as source documents which are original documents, data and records of clinical findings, observations and other activities in a clinical study necessary for the reconstruction and evaluation of the study. Source documents will include hospital records, clinical and office charts, laboratory notes, memoranda, subject diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files and records kept at the pharmacy, at the laboratories and at medical/technical departments involved in the clinical study. The Investigator agrees to allow direct access to all essential clinical study documents for the purpose of monitoring and/or auditing by the Sponsor (or an authorized representative) and inspection by the appropriate national and foreign regulatory authorities.
View SourceView Similar (2)
Essential Study Documents. Essential study documents are among the critical documents required before study enrollment is to occur. Essential documents, as well as supplemental information such as the Investigator’s Brochure, Pharmacy Manual, CRF Completion Guidelines, final protocol, as specified in the Clinical Operations Manual and/or Regulatory Binder, must be kept on-site in a designated study site file. The study site files will also contain, including but not limited to, patient accountability records, drug accountability (receipt/dispensing) records, Sponsor/Investigator correspondence, IRB/IEC correspondence, deviations, biological sample records, and SAE and Investigational New Drug (IND) safety reports/Safety Alert Letters.
View Source

Related to Essential Study Documents

  • Executed Agreement The Offerors shall have received from the Placement Agents an executed copy of this Agreement.

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • This Agreement This Agreement has been duly authorized, executed and delivered by the Company.

  • Development Agreement As soon as reasonably practicable following the ISO’s selection of a transmission Short-Term Reliability Process Solution, the ISO shall tender to the Developer that proposed the selected transmission Short-Term Reliability Process Solution a draft Development Agreement, with draft appendices completed by the ISO to the extent practicable, for review and completion by the Developer. The draft Development Agreement shall be in the form of the ISO’s Commission-approved Development Agreement for its Reliability Planning Process, which is in Appendix C in Section 31.7 of Attachment Y of the ISO OATT, as amended by the ISO to reflect the Short-Term Reliability Process. The ISO and the Developer shall finalize the Development Agreement and appendices as soon as reasonably practicable after the ISO’s tendering of the draft Development Agreement. For purposes of finalizing the Development Agreement, the ISO and Developer shall develop the description and dates for the milestones necessary to develop and construct the selected project by the required in-service date identified in the STAR or Generator Deactivation Assessment, including the milestones for obtaining all necessary authorizations. Any milestone that requires action by a Connecting Transmission Owner or Affected System Operator identified pursuant to Attachment P of the ISO OATT to complete must be included as an Advisory Milestone, as that term is defined in the Development Agreement. If the ISO or the Developer determines that negotiations are at an impasse, the ISO may file the Development Agreement in unexecuted form with the Commission on its own, or following the Developer’s request in writing that the agreement be filed unexecuted. If the Development Agreement is executed by both parties, the ISO shall file the agreement with the Commission for its acceptance within ten (10) Business Days after the execution of the Development Agreement by both parties. If the Developer requests that the Development Agreement be filed unexecuted, the ISO shall file the agreement at the Commission within ten (10) Business Days of receipt of the request from the Developer. The ISO will draft, to the extent practicable, the portions of the Development Agreement and appendices that are in dispute and will provide an explanation to the Commission of any matters as to which the parties disagree. The Developer will provide in a separate filing any comments that it has on the unexecuted agreement, including any alternative positions it may have with respect to the disputed provisions. Upon the ISO’s and the Developer’s execution of the Development Agreement or the ISO’s filing of an unexecuted Development Agreement with the Commission, the ISO and the Developer shall perform their respective obligations in accordance with the terms of the Development Agreement that are not in dispute, subject to modification by the Commission. The Connecting Transmission Owner(s) and Affected System Operator(s) that are identified in Attachment P of the ISO OATT in connection with the selected transmission Short-Term Reliability Process Solution shall act in good faith in timely performing their obligations that are required for the Developer to satisfy its obligations under the Development Agreement.

  • Construction Document Phase 1.4.1 Based on the approved Design Development Documents, Guaranteed Maximum Price, coordinated models and any further adjustments in the scope or quality of the Project or in the Amount Available for the Construction Contract authorized by the Owner, the Architect/Engineer shall prepare, for approval by the Owner and review by the Construction Manager, Construction Documents consisting of Drawings, Schedules and Specifications derived from the model(s) in accordance with Owner’s written requirements setting forth in detail the requirements for construction of the Project, including, without limitation, the BIM Execution Plan and “Facility Design Guidelines”. The Plans, Drawings and Specifications for the entire Project shall be so prepared that same will call for the construction of the building and related facilities, together with its built-in permanent fixtures and equipment which will cost not more than the Guaranteed Maximum Price accepted by Owner, or the Amount Available for the Construction Contract established by Owner if no Guaranteed Maximum Price proposal has been accepted by Owner. The Architect/Engineer will be responsible for managing the design to stay within such Guaranteed Maximum Price proposal or Amount Available for the Construction Contract. The Architect/Engineer shall review the Construction Documents as they are being prepared at intervals appropriate to the progress of the Project with the Owner and Construction Manager at the Project site or other location specified by Owner in the State of Texas. The Architect/Engineer shall utilize the model(s) to support the review process during Construction Documents. The Architect/Engineer shall allow the Construction Manager to utilize the information uploaded into Owner’s PMIS to assist the Construction Manager in fulfilling its responsibilities to the Owner. 1.4.2 As a part of Construction Documents Phase, Architect/Engineer shall accomplish model coordination, aggregation and “clash detection” to remove conflicts in design between systems, structures and components. Model coordination shall occur at all reviews during the Construction Documents Phase as identified in the BIM Execution Plan. Architect/Engineer shall utilize Owner’s PMIS to accomplish model coordination and collaborate with Construction Manager in the resolution of critical clashes identified by the Construction Manager. Architect/Engineer shall demonstrate and provide written assurance to Owner that conflicts/collisions between models have been resolved. 1.4.3 The Architect/Engineer shall consult with the Owner and Construction Manager on matters such as construction phasing and scheduling, bid or proposal alternates, liquidated damages, the construction contract time period, and other construction issues appropriate for the Project. The Architect/Engineer shall assist the Owner and Construction Manager in the preparation of the necessary bidding information, bidding forms, RFP information, and RFP forms, and the Conditions of the Contract. 1.4.4 The Architect/Engineer shall assist the Owner in connection with the Owner’s responsibility and procedures for obtaining approval of all building and accessibility authorities having jurisdiction over the Project. 1.4.5 The Architect/Engineer shall provide coordination and inclusion of sequence of operations for all operable systems in the facility as defined by Owner during Design Development. 1.4.6 The Architect/Engineer shall review the Estimated Construction Cost prepared by the Construction Manager, and shall provide written comments. 1.4.7 The Architect/Engineer shall participate in a final review of the Construction Documents and model(s) with the Owner and Construction Manager at the Project location or other location specified by Owner in the State of Texas. Prior to the Owner’s approval of the Construction Documents, the Architect/Engineer shall incorporate such changes as are necessary to satisfy the Owner’s review comments. 1.4.8 The Architect/Engineer shall provide a list of all manufacturer warranties and submittals that are required by their specification. 1.4.9 Before proceeding into the Bidding and Proposal Phase, the Architect/Engineer shall obtain Owner’s written acceptance of the Construction Documents and approval of the Final Amount Available for the Construction Contract as approved by the Board of Regents.