Subject Withdrawal Criteria and Procedures Sample Clauses

Subject Withdrawal Criteria and Procedures. In accordance with the Declaration of Helsinki (in accordance with the applicable country’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 In addition, a subject may be withdrawn from the study as described in Section 3.5 (stopping rules and discontinuation criteria), Section 6.4.2 (concomitant medications not permitted) and Section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withdrawal should be made (see Section 5.2.7) and an explanation given of why the subject is withdrawing or being withdrawn from the study.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

  • RECOVERY PROCEDURES The nature and severity of any disaster will influence the recovery procedures. One crucial factor in determining how BellSouth will proceed with restoration is whether or not BellSouth's equipment is incapacitated. Regardless of who's equipment is out of service, BellSouth will move as quickly as possible to aid with service recovery; however, the approach that will be taken may differ depending upon the location of the problem.

  • 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 Xxxxx 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 xxxxxxx 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 XXXXXX.

  • Formal Procedures Level 1: In the event the matter is not resolved informally, the grievance shall be submitted in writing to the appropriate supervisor within twenty (20) working days of the occurrence giving rise to the grievance. Such statement of grievance shall set forth the nature of the grievance, the facts on which it is based, the provisions of the Agreement allegedly violated, and the remedy requested. Any grievance not submitted in writing to Level 1 by the employee within twenty (20) working days of the occurrence shall be considered waived. Level 2: If appealed, the written grievance shall be presented by the grievant and/or the Union and discussed at an informal meeting within ten (10) working days of receipt of the written grievance, with the Superintendent of Schools or a designated representative. The Employer- designated representative shall give the Union the Employer’s answer in writing within ten (10) working days after the review meeting. A grievance not resolved in Level 2 may be appealed in writing to Level 3 by the Union within ten (10) working following the Employer-designated representative’s final answer in Level 2. Any grievance not appealed in writing to Level 3 by the Union within ten (10) working days shall be considered waived. Level 3: A grievance unresolved in Level 2 and appealed to Level 3 by the Union shall be submitted to arbitration subject to the provisions of PELRA. If a mutually-acceptable arbitrator cannot be agreed upon, the selection of an arbitrator shall be made from a list of five (5) names provided by the procedures of the Minnesota Bureau of Mediation Services, at the request of the Union. 3.1 The arbitrator shall have no right to amend, modify, or disregard the terms and conditions of this Agreement. The arbitrator shall consider and decide only the specific issue(s) submitted in writing by the Employer and the Union, and shall have no authority to make decisions on any other issue not so submitted. 3.2 The arbitrator shall be without power to make decisions contrary to, or inconsistent with the statutory rights and obligations of the parties, or modifying in any way the application of laws, rules or regulations having the force and effect of law. The arbitrator’s decision shall be submitted in writing, with copies to both parties, and to the Bureau of Mediation Services within thirty (30) days following the close of the hearing or the submission of briefs by the parties, whichever be later, unless the parties agree to an extension. The decision shall be binding on both the Employer and the Union and shall be based solely on the arbitrator’s interpretation or application of the terms of this Agreement and the facts of the grievance presented. 3.3 The fees and expenses for the arbitrator’s services and proceedings shall be borne equally by the Employer and the Union. All other expenses shall be borne by the party incurring the expense. If either party desires a verbatim record of the proceedings, it may cause such a record to be made, providing it pays for the record. If both parties desire a verbatim record of the proceedings, the cost shall be shared equally.

  • Election Procedures Each holder of record of shares of Company Common Stock (“Holder”) shall have the right, subject to the limitations set forth in this Article III, to submit an election with respect to the shares of Company Virginia Sub Common Stock to be received by such holder in the Reincorporation Merger in accordance with the following procedures: (a) Each Holder may specify in a request made in accordance with the provisions of this Section 3.1 (herein called an “Election”) (i) the number of shares of Company Virginia Sub Common Stock to be owned by such Holder as a result of the Reincorporation Merger with respect to which such Holder desires to make a Share Election and (ii) the number of shares of Company Virginia Sub Common Stock to be owned by such Holder as a result of the Reincorporation Merger with respect to which such Holder desires to make a Cash Election. (b) Parent shall prepare a form reasonably acceptable to the Company (the “Form of Election”) which shall be mailed to record holders of Company Common Stock so as to permit those holders to exercise their right to make an Election prior to the Election Deadline. (c) Parent shall make the Form of Election initially available not less than twenty (20) business days prior to the anticipated Election Deadline and shall use all reasonable efforts to make available as promptly as possible a Form of Election to any stockholder of the Company who requests such Form of Election following the initial mailing of the Forms of Election and prior to the Election Deadline. The Form of Election shall contain instructions for effecting the surrender of Company Certificates (which, following the Reincorporation Merger shall represent Company Virginia Sub Common Stock) in exchange for receipts representing the Parent ADSs, as well as the Cash Consideration and cash in lieu fractional shares and, if any Holder so elects and subject to the proviso to the last sentence of Section 2.4(a)(iv), Parent Ordinary Shares in account entry form in lieu of Parent ADSs. (d) Any Election shall have been made properly only if the person authorized to receive Elections and to act as exchange agent under this Agreement, which person shall be a bank or trust company selected by Parent and reasonably acceptable to the Company (the “Exchange Agent”), pursuant to an agreement (the “Exchange Agent Agreement”) entered into prior to the mailing of the Form of Election to Company stockholders, shall have received, by the Election Deadline, a Form of Election properly completed and signed and accompanied by Company Certificate(s) (which, following the Reincorporation Merger shall represent Company Virginia Sub Common Stock) to which such Form of Election relates or by an appropriate customary guarantee of delivery of such certificates, as set forth in such Form of Election, from a member of any registered national securities exchange or a commercial bank or trust company in the United States; provided, that such Company Certificates are in fact delivered to the Exchange Agent by the time required in such guarantee of delivery. Failure to deliver shares of Company Common Stock covered by such a guarantee of delivery within the time set forth on such guarantee shall be deemed to invalidate any otherwise properly made Election, unless otherwise determined by Parent, in its sole discretion. As used herein, unless otherwise agreed in advance by the parties, “Election Deadline” means 5:00 p.m. local time (in the city in which the principal office of the Exchange Agent is located) on the date that Parent and the Company shall agree is as near as practicable to five (5) business days prior to the expected Closing Date. Parent and the Company shall cooperate to issue a press release reasonably satisfactory to each of them announcing the date of the Election Deadline not more than twenty (20) business days before, and at least ten (10) business days prior to, the Election Deadline.

  • DISCIPLINE PROCEDURES The Employer agrees to provide the employee with written notification of a disciplinary document that is to be made a part of the employee’s personnel file. In instances where the Employer desires to conduct an investigatory interview with an employee, the employee shall be entitled upon request to have an Association representative present at the interview. A copy of all disciplinary actions involving suspension or discharge will also be provided to the Association, unless the employee requests that the matter be kept confidential.

  • New Procedures New procedures as to who shall provide certain of these services in Section 1 may be established in writing from time to time by agreement between the Fund and the Transfer Agent. The Transfer Agent may at times perform only a portion of these services and the Fund or its agent may perform these services on the Fund's behalf;

  • Safety Procedures The Contractor shall: (a) comply with all applicable safety regulations according to Attachment H; (b) take care for the safety of all persons entitled to be on the Site; (c) use reasonable efforts to keep the Site and Works clear of unnecessary obstruction so as to avoid danger to these persons; (d) provide fencing, lighting, guarding and watching of the Works until completion and taking over under clause 10 [Employer's Taking Over]; and (e) provide any Temporary Works (including roadways, footways, guards and fences) which may be necessary, because of the execution of the Works, for the use and protection of the public and of owners and occupiers of adjacent land.

  • Induction Procedures a) The parties to this Agreement acknowledge that it is in the interests of the industry that all new employees and employers on a building project understand their obligations to this Agreement and are introduced to their jobs in a manner which will help them work safely and efficiently. b) In order to achieve this it is recommended that, in conjunction with the Site Management, Job Xxxxxxx and Safety Supervisor/Safety Committee, new employees and new employers be given an explanation of the following: ⮚ The Rights and Obligations of this Agreement including its disputes/grievance resolution procedures; ⮚ The appropriate issue of work clothing and safety equipment as per this Agreement; ⮚ Safety Rules and Procedures including relevant legislation; ⮚ Superannuation entitlements; ⮚ Long Service Leave provisions; ⮚ Redundancy Pay entitlements; ⮚ Site Emergency procedures; ⮚ Award or Enterprise Agreement rates of pay; ⮚ Site-specific matters such as security, etc. procedures; ⮚ Rights, obligations and benefits of union membership. c) The induction presentation and material shall have regard to the language skills of the employee/employer.

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