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Tm ( )Tj ET EMC /P <>BDC BT /TT6 1 Tf 9.5 0 0 9.5 37 545.096 Tm [(T)70(o)0( accomplish this: )]TJ ET EMC /P <>BDC BT /TT2 1 Tf 9.5 0 0 9.5 129.302 545.096 Tm (Cenduit worked closely with all)Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 266.8336 545.096 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 527.096 Tm [(trial stakeholders to document r)20(oles, r)20(esponsibilities,)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 273.1797 527.096 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 509.096 Tm [(and timing of activities r)20(elated to data tr)20(ansition.)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 254.1321 509.096 Tm ( )Tj ET EMC /P <>BDC BT /TT6 1 Tf 9.5 0 0 9.5 37 480.296 Tm [(Documented data import r)20(equir)20(ements and )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 247.1401 480.296 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 462.296 Tm (associated plan:)Tj ET EMC /P <>BDC BT /TT2 1 Tf 9.5 0 0 9.5 113.399 462.296 Tm [( Including the agr)20(eed tr)20(ansition )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 256.7162 462.296 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 444.296 Tm [(appr)20(oach, and mapping differ)20(ent patient/material)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 259.7656 444.296 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 426.296 Tm [(statuses fr)20(om the pr)20(e)20(vious system, as well as the )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 257.0867 426.296 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 408.296 Tm [(detail r)20(egar)20(ding r)20(oles, r)20(esponsibilities, and risks )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 252.2986 408.296 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 390.296 Tm (associated with this import.)Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 159.9015 390.296 Tm ( )Tj ET EMC /P <>BDC BT /TT6 1 Tf 9.5 0 0 9.5 37 361.496 Tm (System validation performed via testing the )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 248.6031 361.496 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 343.496 Tm (data import script, and mapping against the )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 249.8096 343.496 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 325.4959 Tm [(documented r)20(equir)20(ements.)]TJ ET EMC /P <>BDC BT /TT2 1 Tf 9.5 0 0 9.5 166.7892 325.4959 Tm ( Additional testing )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 250.6171 325.4959 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 307.4959 Tm [(was completed using a variety of scenarios fr)20(om )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 254.6451 307.4959 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 289.4959 Tm [(legacy data, and for individual patient r)20(ecor)20(ds, b)20(y)0( )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 259.2716 289.4959 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 271.4959 Tm [(ensuring that the ne)20(xt tr)20(ansaction completed )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 241.5446 271.4959 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 253.4959 Tm [(to the corr)20(ect e)20(xpected outcome within the Cenduit)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 266.6436 253.4959 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 235.4959 Tm [(IRT test envir)20(onment.)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 133.0641 235.4959 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 206.696 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 177.896 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 37 149.096 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 736.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 708.0445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 589.2445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 548.4445 Tm ( )Tj ET EMC /P <>BDC BT /TT6 1 Tf 9.5 0 0 9.5 303.4674 519.6445 Tm [(Managing the tr)20(ansition stakeholder )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 488.423 519.6445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 501.6445 Tm (communication: )Tj ET EMC /P <>BDC BT /TT2 1 Tf 9.5 0 0 9.5 383.2104 501.6445 Tm [(Cenduit, the sponsor)60(, and all trial)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 530.6599 501.6445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 483.6445 Tm [(stakeholders collabor)20(ated to identify a suitable time)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 535.0205 483.6445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 465.6445 Tm (point for managed trial activities during the identi)Tj ET EMC /Span <>BDC BT 9.5 0 0 9.5 525.777 465.6445 Tm (-)Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 447.6445 Tm [(fied tr)20(ansition windo)20(w)40(.)0( A ke)20(y activity in the data )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 517.6926 447.6445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 429.6445 Tm [(upload pr)20(ocess into Cenduit)-20()30(s)0( IRT: tr)20(ansformation )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 526.6794 429.6445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 411.6445 Tm [(of data values fr)20(om the pr)20(e)20(vious IRT system into a)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 526.366 411.6445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 393.6445 Tm [(compatible format. Sites wer)20(e also tr)20(ained to use )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 524.2189 393.6445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 375.6445 Tm [(the Cenduit IRT prior to the system tr)20(ansition.)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 507.4041 375.6445 Tm ( )Tj ET EMC /P <>BDC BT /TT6 1 Tf 9.5 0 0 9.5 303.4674 346.8445 Tm [(T)70(o)0( ensur)20(e all data captur)20(e, pr)20(e-Go-Live: )]TJ ET EMC /P <>BDC BT /TT2 1 Tf 9.5 0 0 9.5 490.7695 346.8445 Tm (Ensuring)Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 530.4321 346.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 328.8445 Tm [(data was immediately r)20(eady for use for all ongoing)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 532.6265 328.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 310.8445 Tm (patient visits, the sponsor limited activity within )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 517.8921 310.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 292.8445 Tm [(the pr)20(e)20(vious IRT system, to ensur)20(e sour)20(ce data )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 514.3201 292.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 274.8445 Tm [(stability)40(. After the last import was pr)20(o)20(vided b)20(y)0( the)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 524.8745 274.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 256.8445 Tm [(sponsor)60(, historic data was uploaded into the )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 506.1406 256.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 238.8445 Tm [(Cenduit IRT as part of Go-live activities. Fr)20(om that)]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 523.4305 238.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 220.8445 Tm [(point, no further tr)20(ansactions within the pr)20(e)20(vious )]TJ ET EMC /P <>BDC BT 9.5 0 0 9.5 525.15 220.8445 Tm ( )Tj ET EMC /P <>BDC BT 9.5 0 0 9.5 303.4674 202.8445 Tm [(IRT system occurr)20(ed.)]TJ ET EMC /P <>BDC BT 8 0 0 8 492.4001 21.0323 Tm [(www)40(.iqvia.com/oct | )]TJ ET EMC /P <>BDC BT 8 0 0 8 580.424 21.0323 Tm (3)Tj ET EMC /Figure <>BDC Q q 1 i 670.828 738 m 945.946 738 l 994.575 738 1033.997 698.578 1033.997 649.949 c 1033.997 601.319 994.575 561.897 945.946 561.897 c 395.711 561.897 l 347.082 561.897 307.66 601.319 307.66 649.948 c 307.66 698.578 347.082 738 395.711 738 c h 585 21.032 m W* n 0 792 612 -792 re 306 396.12 m W n 0 792.12 612 -792 re W n /GS1 gs q -307.444 0 0 179.102 613.352 560.322 cm /Im12 Do Q EMC Q endstream endobj 182 0 obj <>/XObject<>/ExtGState<>>> endobj 184 0 obj <> endobj 204 0 obj <> endobj 222 0 obj <>stream /Artifact <>BDC q 1 i 0 792 612 -792 re 306 396.12 m W n 0 792.12 612 -792 re W n 0 0 0 0 k /GS1 gs 28.5 .12 583.5 76.754 re f EMC /Figure <>BDC Q q 1 i 2 791 612 -792 re W n 28.5 76.874 583.5 -76.874 re W* n 0 792 612 -792 re 306 396.12 m W n 0 792.12 612 -792 re W n .4 1 .1 .26 k /GS1 gs q 1 0 0 1 48.627 32.318 cm 0 0 m -2.002 0 l -2.379 0 -2.673 .305 -2.673 .671 c -2.673 1.036 -2.379 1.341 -2.002 1.341 c 3.474 1.341 l 3.838 1.341 4.133 1.036 4.133 .671 c 4.133 .305 3.838 0 3.474 0 c 1.46 0 l 1.46 -6.236 l 1.46 -6.636 1.13 -6.954 .73 -6.954 c .33 -6.954 0 -6.636 0 -6.236 c h 6.136 -6.165 m 6.136 .612 l 6.136 1.023 6.454 1.341 6.866 1.341 c 11.658 1.341 l 12.012 1.341 12.306 1.047 12.306 .694 c 12.306 .329 12.012 .047 11.658 .047 c 7.584 .047 l 7.584 -2.095 l 11.128 -2.095 l 11.482 -2.095 11.776 -2.389 11.776 -2.753 c 11.776 -3.106 11.482 -3.389 11.128 -3.389 c 7.584 -3.389 l 7.584 -5.6 l 11.717 -5.6 l 12.07 -5.6 12.365 -5.895 12.365 -6.248 c 12.365 -6.613 12.07 -6.895 11.717 -6.895 c 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