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. 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 reporting period, a telephone reminder will be sent 7 days prior to the 01 May. [h] ...
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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...
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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