Subject Withdrawal Criteria and Procedures Clause Samples

Subject Withdrawal Criteria and Procedures. In accordance with the Declaration of Helsinki (in accordauce with the applicable couutry's acceptance), each subject is free to withdraw from the study at any time. The investigator also has the right to withdraw a subject from the study in the event of concurrent illness, AEs, pregnancy (see Section 8.1.5), or other reasons concerning the health or wellbeing of the subject, or in the case of lack of cooperation. In addition, a subject may be withdrawn from the study as described in Section 3.5 (stopping rules and discontinuation criteria), Section 6.4.2 (concomitant medications not permitted) and Section 8.1.7 (discontinuation due to AEs). Should a subject decide to withdraw from the study after administration of IMP, or should the investigator decide to withdraw the subject, all efforts will be made to complete and report the observations up to the time of withdrawal as thoroughly as possible. A complete final evaluation at the time of the subject's withdrawal should be made (see Section 5.2.7) and an explanation given of why the subject is withdrawing or being withdrawn from the study. As far as possible, all efforts should be made to ensure the subject attends the Withdrawal (EOS) Visit, with at least 12 weeks follow-up after their most recent IMP administration. The reason for and date of withdrawal from the study must be recorded on the eCRF. If a subject withdraws consent, every attempt will be made to determine the reason. If the reason for withdrawal is an AE, or clinically significant laboratory test abnormality, monitoring will continue until the event has resolved or stabilised, until the subject is referred to the care of a local health care professional, or until a determination of a cause unrelated to the IMP or study procedure is made. The specific AE must be recorded on the eCRF.
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Related to Subject Withdrawal Criteria and Procedures

  • Withdrawal Procedures Upon the withdrawal of the privileges of this Agreement, the Resident shall vacate the Room within the time frame given, and deliver to the Manager vacant possession of the Room together with all of the furnishings, fixtures, appliances and telephone of the Residence, and the furnishings and fixtures shall be in good condition, with reasonable wear and tear excepted. The Resident will follow the Move-out Procedures explained in section 3.02 of this Agreement and all additional directions communicated by the Manager.

  • WITHDRAWAL PROVISIONS At or before the Income Date, the Owner may withdraw all or part of the amounts under this Contract by informing the Company at the Service Center. For full withdrawal, this Contract, or a completed Lost Contract Affidavit, must be returned to the Service Center. Premiums withdrawn from the Contract Value may be subject to a Withdrawal Charge and Recapture Charge as explained in more detail below. Premiums that are no longer subject to the Withdrawal Charge and Recapture Charge (and not previously withdrawn), plus earnings may be withdrawn free of Withdrawal Charges and Recapture Charges at any time. Upon full withdrawal, the Owner will receive the Withdrawal Value. The Withdrawal Value will be based on values at the end of the Business Day in which the request for withdrawal is received at the Service Center in Good Order. In no event shall the amount withdrawn, whether a full withdrawal or partial withdrawal, exceed the Withdrawal Value. Except in connection with a systematic withdrawal program, the minimum partial withdrawal amount is $500, or if less, the Owner's entire interest in the Investment Division or Fixed Account Option from which a withdrawal is requested. The Owner's interest in the Investment Division or Fixed Account Option from which the withdrawal is requested must be at least [$100] after the withdrawal is completed or the Owner's entire interest in the Investment Division or Fixed Account Option will be withdrawn. Unless otherwise specified, the withdrawal will be made from each Investment Division and each Fixed Account Option in proportion to their current value. Withdrawals will be based on values at the end of the Business Day on which the request for withdrawal is received in Good Order at the Service Center. The Company will waive the Withdrawal Charge and Recapture Charge on any withdrawal necessary to satisfy the minimum distribution requirements of the Internal Revenue Code. Any withdrawal in excess of the required minimum distribution will cause the entire amount to be subject to any applicable Withdrawal Charge and Recapture Charge. You may elect to take a systematic withdrawal by surrendering a specific sum or a certain percentage on a monthly, quarterly, semiannual or annual basis, subject to a $50 minimum withdrawal. Such withdrawals will be counted in determining the portion of the Contract Value taken as an Additional Free Withdrawal. Systematic withdrawals in excess of the Additional Free Withdrawal amount may be subject to a Withdrawal Charge and Recapture Charge.

  • Evaluation Procedures The following procedures for employee evaluation shall be utilized for the term of this Agreement: 1. Orientation materials related to evaluation procedures will be provided to all employees by the 10th school day. 2. Employees shall submit to their evaluator a complete listing of proposed objectives, and measurement activities related thereto, to be considered in the annual evaluation by the 25th school day. 3. The evaluator shall have completed by 30th school day annual objective setting conference with employee. 4. The evaluator shall by the 40th school day determine and shall provide the employee with a complete listing of actual objectives from those proposed by the evaluator and employee, and measurement activities from those proposed by the evaluator and employee, and measurement activities related thereto, that will be incorporated in the annual evaluation that the evaluator will prepare for the employee. The objectives and related measurement activities referred to herein shall be in accordance with the employee job description prescribed by the District. The District will make every attempt to have the number of objectives required to be uniform from site to site. 5. Within a reasonable time after the request, the evaluator shall be provided with a written progress report from the employee containing the latter's perception of the progress being made toward the achievement of the objectives prescribed in Item 3, above. During the course of the evaluation period, circumstances may change which may result in the modification of the original standards and objectives. These changes may be initiated by the supervisor or the employee. Agreement of both parties is required. 6. The evaluator, by the 145th school day, shall have conducted classroom observations in order to gather data on employee performance as the evaluator believes to be related to: A. The actual objectives and measurement activities described in Item 3, above; B. Other criteria for employee evaluation and appraisal that are established by the District ▇▇▇▇▇ Act Guidelines. At the discretion of the evaluator, tenured teachers may receive only one (1) formal instructional observation per year. Probationary teachers will receive two (2) formal instructional observations per year. Prior to conducting formal instructional observations regarding the teacher's duties related to the instructional objectives herein described, the teacher shall be notified of the observation prior to the beginning of the teacher's actual instructional day. Upon the request of the evaluatee or when, in the evaluator's judgment, additional instructional classroom observations are necessary, such observations may be conducted. Within a reasonable time, an employee shall be provided with a written statement regarding instructional observations that have been conducted. Such written statements shall contain a summary of the instructional activities observed, and any suggestions being made by the observer for possible improvement by the employee to include, but not be limited to, the following: 1) Specific directives for improvement 2) Assistance to implement such directives as (a) Provisions of additional resources; (b) Mandatory training programs designed to improve performance to be paid by the District. A final and written report of the achievement of objectives, and measurement information related thereto shall be submitted by the employee to the evaluator by the 140th school day. 7. The evaluator shall prepare a written District evaluation form of employee performance and transmit the evaluation to the employee. The employee may submit a written reaction or response to the evaluation and such response shall be attached to the evaluation and placed in the employee's permanent personnel file which shall be maintained in the District Office. Permanent employees shall be evaluated at least once every other year, and in no event later than 30 days before the last school day scheduled on the school calendar of the current school year. Probationary employees shall be evaluated at least once each year and in no event later than the 150th school day. 8. Employees who meet each of the following conditions shall be evaluated up to every five

  • Deviation from Grievance Procedure The Employer agrees that, after a grievance has been discussed at Step 2 of the grievance procedure the Employer or his representatives shall not initiate any discussion or negotiations with respect to the grievance, either directly or indirectly with the aggrieved employee without the consent of the ▇▇▇▇▇▇▇ or the Union.

  • Review Procedures a. In consultation with the Illinois SHPO, NRCS shall identify those undertakings with little to no potential to affect historic properties and list those undertakings in Appendix A. Upon the determination by the CRS that a proposed undertaking is included in Appendix A, the NRCS is not required to consult further with the SHPO for that undertaking. A list of undertakings with the potential to affect historic properties comprises Appendix B. b. The lists of undertakings provided in Appendices A and B may be modified through consultation and written agreement between the NRCS State Conservationist and the SHPO without requiring an amendment to this Illinois Prototype Agreement. The NRCS State Office will maintain the master list and will provide an updated list to all consulting parties with an explanation of the rationale for classifying the practices accordingly. c. Undertakings identified in Appendix B shall require further review as outlined in Stipulation V. a. The NRCS shall consult with the SHPO to define the undertaking’s APE, identify and evaluate historic properties that may be affected by the undertaking, assess potential effects, and identify strategies for resolving adverse effects prior to implementing the undertaking. 1) NRCS may provide its proposed APE, identification of historic properties and/or scope of identification efforts, and assessment of effects in a single transmittal to the SHPO, provided this documentation meets the substantive standards in 36 CFR Part 800.4-5 and 800.11. 2) The NRCS shall attempt to avoid adverse effects to historic properties whenever possible; where historic properties are located in the APE, NRCS shall describe how it proposes to modify, buffer, or move the undertaking to avoid adverse effects to historic properties. 3) Where the NRCS proposes a finding of "no historic properties affected" or "no adverse effect" to historic properties, the SHPO shall have 30 calendar days from receipt of this documented description and information to review it and provide comments. The NRCS shall take into account all timely comments. i. If the SHPO, or another consulting party, disagrees with NRCS' findings and/or determination, it shall notify the NRCS within the thirty (30) calendar daytime period. The NRCS shall consult with the SHPO or other consulting party to attempt to resolve the disagreement. If the disagreement cannot be resolved through this consultation, NRCS shall follow the dispute resolution process in Stipulation VIII below. ii. If the SHPO does not respond to the NRCS within the thirty (30) calendar day period and/or the NRCS receives no objections from other consulting parties, or if the SHPO concurs with the NRCS' determination and proposed actions to avoid adverse effects, the NRCS shall document the concurrence/lack of response within the review time noted above and may move forward with the undertaking. 4) Where a proposed undertaking may adversely affect historic properties, NRCS shall describe proposed measures to minimize or mitigate the adverse effects, and follow the process in 36 CFR Part 800.6, including consultation with other consulting patties and notification to the ACHP, to develop a Memorandum of Agreement to resolve the adverse effects. Should the proposed undertaking have the potential to adversely affect a known NHL, the NRCS shall, to the maximum extent possible, undertake such planning and actions that may be necessary to minimize harm to the NHL in accordance with 54 U.S.C. § 306107 of the NHPA and 36 CFR Part 800.6 and 800.10, including consultation with the ACHP and respective National Park Service, Regional National Historic Landmark Program Coordinator, to develop a Memorandum of Agreement. d. NRCS will conduct archaeological surveys and will submit reports and other documentation to SHPO for review and comment. When no archaeological sites have been located by the archaeological survey, NRCS may proceed with the proposed undertaking. Reports for negative surveys must be submitted to SHPO on a quarterly basis. All positive and negative reports submitted to SHPO will be sent digitally for submission to the Inventory of Illinois Archaeological Sites (IAS) data file maintained by staff at the Illinois State Museum (ISM) housed under the Illinois Department of Natural Resources (IDNR). The NRCS further agrees that access to specific site location data will be restricted to the CRS, the NRCS field personnel installing conservation practices adjacent to the cultural resource, and the landowner. Specific site location information for individual projects will be maintained in a secure cultural resources file kept in the field offices and will not be available to the public. e. Curation: NRCS personnel will not collect artifactual material during routine field inspections. However, if a professional survey, evaluation testing, or mitigation is required, NRCS shall ensure that all materials and records resulting from cultural resources surveys or data recovery activities on federal or state property are curated by the Illinois State Museum. The NRCS shall ensure that all records resulting from cultural resource surveys or data recovery activities on private property are curated by the Illinois State Museum or an equivalent curation facility in accordance with 36 CFR Part 79. Subject to the landowner's permission, all objects resulting from cultural resources surveys or data recovery activities are maintained by the Illinois State Museum or equivalent research institution until their analysis is complete and they are returned to their owner(s). Although landowners will be encouraged to donate artifactual material, it is understood that objects collected on private land remain the property of the landowner(s) unless the landowner(s) donates the material to the Illinois State Museum or equivalent research institution. This excludes burial goods, as stipulated by ▇▇▇▇▇▇.