Monitoring of the study Sample Clauses

Monitoring of the study. In the event that sponsor makes monitoring visits, the monitor (hereinafter referred as the "Monitor") of this STUDY will be Mr. /Xxx. Xxxx clic aquí para escribir texto. from the company Xxxx clic aquí para escribir texto.. The Monitor will have access to the clinical records and other clinical documentation on the subjects included in the STUDY by means of the statement attached as Xxxxx XX. Mr. /Xxx. Xxxx clic aquí para escribir texto. guarantees that he/she will maintain the confidentiality of the data to which he /she might have access during the course of the monitoring and that these will only be used for the purposes of monitoring. The Monitor will notify, in writing and with sufficient notice, the HOSPITAL, which will inform its clinical departments participating in the STUDY and the Ethics Committee for Clinical Research of the HOSPITAL, of any monitoring visit, which he/she is to carry out. If during a monitoring visit are detected problems that affect the correct running of the STUDY, the HOSPITAL will be notified. The Sponsor shall provide the Principal Investigator with information about the running of the STUDY, if it is multicentric, and the results obtained at the end of the STUDY or in the moment they are available, and also about the serious unexpected adverse events detected by the sponsor with the STUDY drugs. The monitor shall provide the information on the Clinical Trial progression monthly, or based on the rate of billing. In addition, shall be provided any new information about the product that becomes available during the STUDY. If, at the time of signing this contract, the monitor of the study has not been appointed, the Sponsor will send the Xxxxx XX to the center when they knows their identity to be added to the file of this contract.
Sample 1
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Monitoring of the study. 8.1 SPONSOR will appoint monitor(s), bound by a professional confidentiality obligation, who will work with the INSTITUTION to ensure proper conduct of the Study (hereinafter the ”Monitor(s)”). In this study no onsite monitoring is planned.
Sample 1
Monitoring of the study. Site monitoring for safety is conducted to ensure that human subject protection, study procedures, and laboratory, study drug dosing, and data collection processes are of high quality and meet SIGA, GCP/ICH, and regulatory guidelines. PPD CRA(s) will conduct site monitoring visits as detailed in the monitoring plan. Site investigators will allow the CRA(s), the designated IRB, SIGA or its designee and the FDA to review, audit, and inspect study documents (eg, ICFs, drug accountability and distribution forms, eCRF), pertinent hospital and site records, and source documentation for verification of the study data. Clinical research associates will conduct site visits in accordance with PPD SOPs to monitor the following: study operations, the quality of data collected in the research records, the accuracy and timeliness of data entered in the database, and to determine that all process and regulatory requirements are met. Study monitoring visits will occur at initiation of the study site, at intervals determined by SIGA during conduct of the study, and at completion of the study. The CRA will maintain current personal knowledge of the study through observation, review of study records and source documentation, and discussion of the conduct of the study with the investigator and staff. During the routine monitoring visits, the CRA will perform a 100% source document verification of all subject data entered into the eCRF. Discrepancies, if any, will be clarified with the study site coordinator and investigator, and corrected at the site by the study coordinator. Any questions or required data clarifications will be sent to the study site electronically.
Sample 1

Related to Monitoring of the study

  • MONITORING OF OPERATION AND MAINTENANCE 19.1 Monthly status reports During Operation Period, the Concessionaire shall, no later than 7 (seven) days after the close of each month, furnish to the Authority and the Independent Engineer a monthly report stating in reasonable detail the condition of the Bus Terminal including its compliance or otherwise with the Maintenance Requirements, Maintenance Manual, Maintenance Programme and Safety Requirements, and shall promptly give such other relevant information as may be required by the Independent Engineer. In particular, such report shall separately identify and state in reasonable detail the defects and deficiencies that require rectification.

  • SCHEDULING OF THE WORK The number of working days stipulated for this Contract is 5. These working days shall be consecutive. The Contractor is not required to submit a schedule for this project. Liquidated damages will be assessed beyond the number of working days specified above as well as the completion date as noted in this tender form and agreement. The Contractor must advise the Engineer 48 hours in advance of work starting.

  • TESTING OF THE BCDR PLAN The Service Provider shall test the BCDR Plan on a regular basis (and in any event not less than once in every Contract Year). Subject to paragraph 6.2, the Purchaser may require the Service Provider to conduct additional tests of some or all aspects of the BCDR Plan at any time where the Purchaser considers it necessary, including where there has been any change to the Services or any underlying business processes, or on the occurrence of any event which may increase the likelihood of the need to implement the BCDR Plan. If the Purchaser requires an additional test of the BCDR Plan, it shall give the Service Provider written notice and the Service Provider shall conduct the test in accordance with the Purchaser's requirements and the relevant provisions of the BCDR Plan. The Service Provider's costs of the additional test shall be borne by the Purchaser unless the BCDR Plan fails the additional test in which case the Service Provider's costs of that failed test shall be borne by the Service Provider. The Service Provider shall undertake and manage testing of the BCDR Plan in full consultation with the Purchaser and shall liaise with the Purchaser in respect of the planning, performance, and review, of each test, and shall comply with the reasonable requirements of the Purchaser in this regard. Each test shall be carried out under the supervision of the Purchaser or its nominee. The Service Provider shall ensure that any use by it or any Sub-contractor of “live” data in such testing is first approved with the Purchaser. Copies of live test data used in any such testing shall be (if so required by the Purchaser) destroyed or returned to the Purchaser on completion of the test. The Service Provider shall, within twenty (20) Working Days of the conclusion of each test, provide to the Purchaser a report setting out: the outcome of the test; any failures in the BCDR Plan (including the BCDR Plan's procedures) revealed by the test; and the Service Provider's proposals for remedying any such failures. Following each test, the Service Provider shall take all measures requested by the Purchaser, (including requests for the re-testing of the BCDR Plan) to remedy any failures in the BCDR Plan and such remedial activity and re-testing shall be completed by the Service Provider, at no additional cost to the Purchaser, by the date reasonably required by the Purchaser and set out in such notice. For the avoidance of doubt, the carrying out of a test of the BCDR Plan (including a test of the BCDR Plan’s procedures) shall not relieve the Service Provider of any of its obligations under this Contract. The Service Provider shall also perform a test of the BCDR Plan in the event of any major reconfiguration of the Services or as otherwise reasonably requested by the Purchaser.

  • Monitoring Services IDT staff shall, using methods that include face-to-face and other contacts with the member, monitor the services a member receives. This monitoring shall ensure that:

  • Monitoring Plan keep up with the objectives from the cadetship practice booklet; taking daily notes as well as learning new information every day; currently reporting to the supervisor. Evaluation plan: the final result should be in accordance with the traineeship’s aims and objectives, achieving an improvement of specialty knowledge and language skills. The level of language competence9 in English that the trainee already has or agrees to acquire by the start of the mobility period is: A1 ☐ A2 ☐ B1 ☐ B2 ☒ C1 ☐ C2 ☐ Native speaker ☐ Table B - Sending Institution Please use only one of the following three boxes: 10 The traineeship is embedded in the curriculum and upon satisfactory completion of the traineeship, the institution undertakes to:Award ……...…ECTS credits (or equivalent)11 Give a grade based on: Traineeship certificate ☒ Final report ☒ Interview ☐ Record the traineeship in the trainee's Transcript of Records and Diploma Supplement (or equivalent). Record the traineeship in the trainee's Europass Mobility Document: Yes ☒ No ☐ The traineeship is voluntary and, upon satisfactory completion of the traineeship, the institution undertakes to: Award ECTS credits (or equivalent): Yes ☐ No ☐ If yes, please indicate the number of credits: …. Give a grade: Yes ☐ No ☐ If yes, please indicate if this will be based on: Traineeship certificate ☐ Final report ☐ Interview ☐ Record the traineeship in the trainee's Transcript of Records: Yes ☐ No ☐ Record the traineeship in the trainee's Diploma Supplement (or equivalent). Record the traineeship in the trainee's Europass Mobility Document: Yes ☐ No ☐ The traineeship is carried out by a recent graduate and, upon satisfactory completion of the traineeship, the institution undertakes to: Award ECTS credits (or equivalent): Yes ☐ No ☐ If yes, please indicate the number of credits: …. Record the traineeship in the trainee's Europass Mobility Document (highly recommended): Yes ☐ No ☐ Accident insurance for the trainee The Sending Institution will provide an accident insurance to the trainee (if not provided by the Receiving Organisation/Enterprise): Yes ☐ No ☒ The accident insurance covers: - accidents during travels made for work purposes: Yes ☐ No ☒ - accidents on the way to work and back from work: Yes ☐ No ☒

  • Conduct of the Study The Parties shall perform the Study set forth in Protocol No. [ ] dated [ ] (“Protocol”) in accordance with this Agreement, the Protocol and all applicable laws and regulations. The Institution shall follow all guidelines and instructions reasonably provided by Sponsor. [If applicable:] The Principal Investigator has, in addition to his/her Principal Investigator responsibilities, been appointed to coordinate certain activities at a national level as National Coordinating Investigator. It is the duty of the National Coordinating Investigator to obtain all approvals for the Study required pursuant to Norwegian law or regulatory requirements from the relevant Independent Ethics Committee (“IEC”) before commencing the Study. The National Coordinating Investigator shall also, to the extent required pursuant to Norwegian law or regulatory requirements, notify and obtain the consent of the relevant EC of any amendments to the Protocol. Such approvals shall be forwarded to Sponsor as they are obtained.

  • Rescheduling of Tests If the Independent Engineer certifies to the Authority and the Concessionaire that it is unable to issue the Completion Certificate or Provisional Certificate, as the case may be, because of events or circumstances on account of which the Tests could not be held or had to be suspended, the Concessionaire shall be entitled to re-schedule the Tests and hold the same as soon as reasonably practicable.

  • Monitoring of Contract Performance The Contractor shall comply with the monitoring arrangements set out in the Monitoring Schedule including, but not limited to, providing such data and information as the Contractor may be required to produce under the Contract.

  • Procurement of the Site 10.3.1 Pursuant to the notice specified in Clause 4.1.2, the Authority Representative and the Concessionaire shall, on a mutually agreed date and time, inspect the Site and prepare a memorandum containing an inventory of the Site including the vacant and unencumbered land, buildings, structures, road works, trees and any other immovable property on or attached to the Site. Such memorandum shall have appended thereto an appendix (the “Appendix”) specifying in reasonable detail those parts of the Site to which vacant access and Right of Way has not been granted to the Concessionaire. Signing of the memorandum, in two counterparts (each of which shall constitute an original), by the authorised representatives of the Parties shall, subject to the provisions of Clause 10.2.2, be deemed to constitute a valid licence and Right of Way to the Concessionaire for free and unrestricted use and development of the vacant and unencumbered Site during the Concession Period under and in accordance with the provisions of this Agreement and for no other purpose whatsoever. For the avoidance of doubt, it is agreed that valid licence and Right of Way with respect to the parts of the Site as set forth in the Appendix shall be deemed to have been granted to the Concessionaire upon vacant access thereto being provided by the Authority to the Concessionaire.

  • F2 Monitoring of Contract Performance F2.1 The Contractor shall immediately inform the Authority if any aspect of the Contract is not being or is unable to be performed, the reasons for non-performance, any corrective action and the date by which that action will be completed.

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