Schedule of Assessments Sample Clauses

Schedule of Assessments. A schedule of assessments is provided in Table 3-1 for the main cohort and Table 3-2 for the immunogenicity cohort. A list of evaluations by visit/call day is provided in Appendix 1. Table 3-1 Schedule of Assessments (Main Cohort) Screening / Vaccination Follow-up Visit/Call Day D0[a] D1(+2) D7(+3) D28(±7) D29-EOS[b] Informed consent X Inclusion and exclusion criteria X Medical history reviewed X Physical examination X Urine pregnancy test (women of childbearing potential) X Randomisation X Vaccination X[c] Post-vaccination observation period (30 mins) X eDiaries, tape measure and thermometers provided X Telephone contact X[d] X[d] X (4 weekly)[e] IBM/site appointment system reminder X(weekly)[f] eDiaries completed for local reactogenicity X (daily) eDiaries completed for systemic reactogenicity X (daily) eDiaries completed for unsolicited adverse events X (daily) eDiaries completed for ILI symptoms X (weekly 01 May to 15 October)[g] Nasal swabbing X (if required)[h] Abbreviations: D=day; eDiaries=electronic diaries; EOS=end of study; ILI=influenza-like illness; mins=minutes; SAE=serious adverse event Note: SAEs will be recorded for the duration of the study. [a] Screening and Vaccination can occur on a separate day as long as QIV Vaccination is within the 28 day window [b] Participants will be followed up over the followed-up over the duration of the influenza season into which they are recruited. [c] MVA-NP+M1 or placebo by intramuscular injection. [d] To review adverse events. If the participant has persistent, vaccine-related Grade 3 adverse events during the first 4 weeks post-vaccination they may be asked to attend a further clinical assessment. [e] To remind participants to complete the ILI assessment in their diary and to enquire if they have had any hospitalisations or SAEs (plus other unsolicited adverse events at the first call only); final call performed at the end of the influenza season. [f] Reminders to be sent out weekly to complete the eDiary. Reminders will not be sent between Day 28 and the start of the ILI reporting period on 01 May for participants vaccinated early in the influenza season who have Day 28 assessments prior to the start of the ILI reporting period. [g] Assessment of ILI weekly. In the event of an episode, the severity of symptoms will be recorded daily and any medications taken to treat the symptoms. For participants vaccinated early in the influenza season and who have Day 28 assessments prior to the start of the ILI re...
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Schedule of Assessments. Table 4 lists the overall schedule of assessments for the study. Table 4: Schedule of Assessments Assessment Screen Aa Screen Bb Day 1c Wk 1 (Phone) Day 3±2 Wk 1 Day 7±3 Wk 2 (Phone) Day 10±2 Wk 2 Day 14±3 Wk 3 (Phone) Day 21±2 Wk 4 Day 28±3 Wk 4 (Phone) Day 31±2 Wk 5 (Phone) Day 38±2 Wk 6 Day 42±3 Wk 7 (Phone) Day 45±2 Wk 8 Day 56±3 Wk 12 Day 84±3 Informed consent X Inclusion/ exclusion X Xd Demographics and baseline disease characteristics X Concomitant medications X X X X X X X X X X X X X X X Medical history X Height X X X X X X X X Weight in clinic X X X X X X X X Weight at home X X X X X X X X X X X X X Dispense weight diary X X X X X X Collect/review weight diary X X X X X X X X X X X X ECG X Echocardiograme X Vital sign measurements X X X X X X X X Physical exam X X X X X X X X Pregnancy test for WOCBPf X X X X X X Study drug administration ---------------------------------------------X----------------------------------------- Dispense study drug X X X X X X Collect study drug X X X X X Telephone contact X X X X X X Adverse event collection gX X X X X X X X X X X X X Genetic testingh X Clinical chemistry (incl. eGFR) X X X X X X X X X BNP and NT-proBNP X X X X X X X X IGF-1 and serum ketones X X X X X X X X Hemoglobin A1c X X Hematology X X X X X X X Urinalysis and microscopy X X X X X X X Urine collection for XXXx X X X X Visual acuity X Audiology assessment X PGIC CGI-I Virus serology X PK samplesj X Assessment Wk 24 Day 168±3 Wk 36 Day 252±3 Wk 48 Day 336±3 Wk 52 Day 364±3 Wk 64 Day 448±5 Wk 76 Day 532±5 Wk 88 Day616±5 Wk 100 or End of Treatmentk Day 700±3 Wk 104 or Follow-upk Day 728±3 Informed consent Inclusion/ exclusion Demographics and baseline disease characteristics Concomitant medications X X X X X X X X X Medical history Height X X X X X X X X X Weight in clinic X X X X X X X X X Weight at home X X X X X X X X Dispense weight diary X X X X X X X Collect/review weight diary X X X X X X X X ECG X X X X Echocardiograme Vital sign measurements X X X X X X X X X Physical exam X X X X X X X X X Pregnancy test for WOCBPf X X X X X X X X X Study drug administration -----------X---------- ---------------------------------------------X----------------------------------------- Dispense study drug X X X X X X Collect study drug X X X X X X X Telephone contact Adverse event collection X X X X X X X X X Genetic testingh Clinical chemistry (incl. eGFR) X X X X X X X X X BNP and NT-proBNP X X X X X X X X X IGF-1 and serum ketones X X X X X X X X X Hemo...
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Schedule of Assessments. A termination case report form (CRF) page should be completed for every randomized subject, whether or not the subject completed the study. The reason for any early discontinuation should be indicated on this form. The primary reason for a subject withdrawing prematurely should be selected from the following standard categories of early termination: • Failure to achieve “smoking reduction” at 24 weeks (>50% reduction of self-reported number of smoked cigarettes during week 20-24, and CO in exhaled air <1 ppm, compared to baseline): such subjects are unlikely to stop smoking during subsequent follow-up which is the aim of the study after 24 weeks.
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Related to Schedule of Assessments

  • Review of assessment The assessment of the applicable percentage should be subject to annual review or earlier on the basis of a reasonable request for such a review. The process of review shall be in accordance with the procedures for assessing capacity under the Supported Wage System.

  • COMPTROLLER’S REPORT ON CHAPTER 313 AGREEMENTS During the term of this Agreement, both Parties shall provide the Comptroller with all information reasonably necessary for the Comptroller to assess performance under this Agreement for the purpose of issuing the Comptroller’s report, as required by Section 313.032 of the TEXAS TAX CODE.

  • Self-Assessment (a) Subject to clause 4.4(b), for Services that are Self-Assessable:

  • Schedule of Rates and Charges Any subconsultant rates and charges set forth in the Schedule of Rates and Charges must be the subconsultant’s actual rates and charges exclusive of any markup. The City will compensate the Consultant in accordance with those rates and charges.

  • UNION DUES AND ASSESSMENTS (a) The Employer shall, as a condition of employment, deduct from the wages or salary of each employee in the bargaining unit, whether or not the employee is a member of the Union, the amount of the regular dues payable to the Union by a member of the Union.

  • Schedule of Deviations 1 Subject . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Subject . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Subject . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Subject . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Subject . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . By the duly authorised representatives signing this agreement, the employer and the contractor agree to and accept the foregoing schedule of deviations as the only deviations from and amendments to the documents listed in the tender data and addenda thereto as listed in the tender schedules, as well as any confirmation, clarification or changes to the terms of the offer agreed by the Tenderer and the employer during this process of offer and acceptance. It is expressly agreed that no other matter whether in writing, oral communication or implied during the period between the issue of the tender documents and the receipt by the Tenderer of a completed signed copy of this Agreement shall have any meaning or effect in the contract between the parties arising from this agreement.

  • Licenses, Permits, Fees and Assessments Consultant shall obtain at its sole cost and expense such licenses, permits and approvals as may be required by law for the performance of the services required by this Agreement. Consultant shall have the sole obligation to pay for any fees, assessments and taxes, plus applicable penalties and interest, which may be imposed by law and arise from or are necessary for the Consultant’s performance of the services required by this Agreement, and shall indemnify, defend and hold harmless City, its officers, employees or agents of City, against any such fees, assessments, taxes, penalties or interest levied, assessed or imposed against City hereunder.

  • Schedule The Work shall be performed as expeditiously as possible in conformity with the schedule requirements contained herein and in the Statement of Work. The draft and final versions of all deliverables shall be submitted by the dates specified in the Exhibit A Schedule and Project Period noted in Item No. 7 of this Agreement. It is understood and agreed that the delivery of the draft and final versions of such deliverables by the Contractor shall occur in a timely manner and in accordance with the requirements of the Exhibit A Schedule.

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