1 00:00:13,580 --> 00:00:15,515 >> Jon McKeeby: Clinical Data Interchange Standards 2 00:00:15,582 --> 00:00:17,283 Consortium, CDISC. 3 00:00:17,350 --> 00:00:21,588 This is part 4 of 4. I'm Jon McKeeby. 4 00:00:21,654 --> 00:00:24,624 I'm the clinical information officer of the Clinical Center 5 00:00:24,691 --> 00:00:26,860 of the National Institutes of Health. 6 00:00:31,631 --> 00:00:34,768 We're going to review CDISC use at NCI. 7 00:00:38,638 --> 00:00:41,508 NCI implements the CDISC standards 8 00:00:41,574 --> 00:00:43,743 across their standards. 9 00:00:43,810 --> 00:00:46,880 They utilize the clinical trial research XML 10 00:00:47,547 --> 00:00:51,518 as part of their standard for protocol representation. 11 00:00:52,085 --> 00:00:56,923 They incorporate the CDISC fields within their own fields. 12 00:00:56,990 --> 00:00:59,459 And so, this is example of the fields 13 00:00:59,526 --> 00:01:02,662 they collect for trial registration, 14 00:01:03,329 --> 00:01:07,567 utilizing CDISC as well as their preferred terms. 15 00:01:13,072 --> 00:01:16,476 And this is example of all the fields that they collect. 16 00:01:17,043 --> 00:01:19,345 They identify the CDISC definition 17 00:01:19,913 --> 00:01:23,583 as well as their preferred term for that field. 18 00:01:28,254 --> 00:01:29,522 This is the CDASH 19 00:01:29,589 --> 00:01:34,561 controlled terminology standard utilized at NCI. 20 00:01:34,627 --> 00:01:40,366 It reviews the CDISC fields as well as the NCI preferred term. 21 00:01:40,433 --> 00:01:44,671 They review commonly used terms across various domains 22 00:01:45,338 --> 00:01:50,243 of concomitant medications, drug accountability, 23 00:01:50,310 --> 00:01:55,281 ECG data, exposure data, vital sign measurements. 24 00:01:59,519 --> 00:02:03,690 And this is example of the CDASH Control Terminology 25 00:02:03,756 --> 00:02:06,226 implemented at NCI. 26 00:02:06,826 --> 00:02:10,029 You see the various control dictionaries on the left. 27 00:02:10,597 --> 00:02:13,766 And then by selecting one, you see the various names, 28 00:02:13,833 --> 00:02:16,803 the data types, the CDISC definition, 29 00:02:16,870 --> 00:02:19,839 as well as the NCI preferred term. 30 00:02:25,845 --> 00:02:29,082 And then this shows it in XML format. 31 00:02:35,154 --> 00:02:39,359 CDISC, the SDTM Controlled Terminology 32 00:02:39,425 --> 00:02:44,397 is also utilized by NCI. 33 00:02:44,464 --> 00:02:48,701 And again, it reviews the CDISC Terminology as well 34 00:02:48,768 --> 00:02:51,237 as the NCI preferred term. 35 00:02:56,843 --> 00:02:59,979 This reviews the various control terminologies. 36 00:03:05,485 --> 00:03:10,356 And then reviews the fields and their values. 37 00:03:15,094 --> 00:03:17,997 There are many different resources that review CDISC 38 00:03:18,598 --> 00:03:22,502 and this is a selection used for this presentation.