Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This  This is an example of a cross-over crossover study where testing 7 smokeless tobacco products were tested. All product products contain nicotine except for product F, which was a nicotine-/tobacco-free product. Subject Each subject first used the product ad libitum and then ; the next day, the product usage was evaluated in the morning, as specified in the protocol in the morning. The subjects Subjects were confined to the site. Product Products were supplied to the subject subjects as needed by site staff.   The sponsor  Each usage was recorded. The applicant did not submit a Product Accountability ( DA ) domain, or the nor an EC domain.   The name of the actual product was not would be used, but a dummy name is used in the this example below.            

Dataset wrap
NameEx
Dataset2
RowSTUDYIDDOMAINUSUBJIDEXSEQEXTRTEXCATEXDOSEEXDOSUEXDOSFRMEXROUTEEXPSTRGEXPSTRGUVISITNUMVISIT
VISITDY 
VISITDYEPOCHEXSTDTCEXENDTC
1ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100011PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg10DAY -1-1
TREATMENT
PRODUCT EXPOSURE2019-06-27T13:10:332019-06-27T13:38:49
2ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100012PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg10DAY -1-1
TREATMENT
PRODUCT EXPOSURE2019-06-27T14:29:132019-06-27T14:54:53
3ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100013PRODUCT CCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-06-28T08:00:122019-06-28T08:30:21
4ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100014PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-06-28T14:01:522019-06-28T14:55:27
5ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100015PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-06-28T15:18:352019-06-28T15:57:33
6ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100016PRODUCT ECONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-06-29T08:00:082019-06-29T08:30:13
7ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100017PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-06-29T14:01:502019-06-29T14:50:11
8ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100018PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-06-29T15:24:332019-06-29T15:59:46
9ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
100019PRODUCT BCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-06-30T08:00:002019-06-30T08:30:00
10ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000110PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-06-30T14:12:322019-06-30T14:47:47
11ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000111PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-06-30T15:24:462019-06-30T16:04:57
12ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000112PRODUCT DCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-01T08:00:002019-07-01T08:30:00
13ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000113PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-01T14:02:362019-07-01T14:47:33
14ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000114PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-01T15:37:452019-07-01T15:58:15
15ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000115PRODUCT ACONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-02T08:00:002019-07-02T08:30:01
16ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000116PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-02T14:11:002019-07-02T14:54:08
17ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000117PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-02T15:38:522019-07-02T15:59:50
18ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000118PRODUCT FCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-03T08:00:002019-07-03T08:30:00
19ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000119PRODUCT GUNCONTROLLED PRODUCT USE3.37gQUIDORAL4mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-03T14:13:142019-07-03T14:57:40
20ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000120PRODUCT GUNCONTROLLED PRODUCT USE3.2gQUIDORAL4mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-03T15:35:012019-07-03T16:07:25
21ALCS-REG-STUDYEXALCS-REG-STUDY_
10001 
1000121PRODUCT GCONTROLLED PRODUCT USE2gQUIDORAL4mg17DAY 7/EARLY TERMINATION7
TREATMENT
PRODUCT EXPOSURE2019-07-04T08:00:042019-07-04T08:30:05
22ALCS-REG-STUDYEXALCS-REG-STUDY_100021PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg10DAY -1-1
TREATMENT
PRODUCT EXPOSURE2019-07-04T14:06:092019-07-04T14:14:14
23ALCS-REG-STUDYEXALCS-REG-STUDY_100022PRODUCT ECONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-07-05T08:00:002019-07-05T08:30:00
24ALCS-REG-STUDYEXALCS-REG-STUDY_100023PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-07-05T14:02:392019-07-05T14:18:57
25ALCS-REG-STUDYEXALCS-REG-STUDY_100024PRODUCT DCONTROLLED PRODUCT USE1POUCHPOUCHORAL4mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-07-06T08:00:002019-07-06T08:30:00
26ALCS-REG-STUDYEXALCS-REG-STUDY_100025PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-07-06T14:00:002019-07-06T14:08:40
27ALCS-REG-STUDYEXALCS-REG-STUDY_100026PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-07-06T15:52:532019-07-06T15:59:21
28ALCS-REG-STUDYEXALCS-REG-STUDY_100027PRODUCT CCONTROLLED PRODUCT USE1POUCHPOUCHORAL6mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-07-07T08:00:002019-07-07T08:30:00
29ALCS-REG-STUDYEXALCS-REG-STUDY_100028PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-07-07T14:01:122019-07-07T14:12:25
30ALCS-REG-STUDYEXALCS-REG-STUDY_100029PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-07-07T14:57:492019-07-07T15:07:07
31ALCS-REG-STUDYEXALCS-REG-STUDY_1000210PRODUCT FCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-08T08:00:002019-07-08T08:30:00
32ALCS-REG-STUDYEXALCS-REG-STUDY_1000211PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL0mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-08T14:00:522019-07-08T14:17:31
33ALCS-REG-STUDYEXALCS-REG-STUDY_1000212PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-08T14:46:072019-07-08T14:53:43
34ALCS-REG-STUDYEXALCS-REG-STUDY_1000213PRODUCT BCONTROLLED PRODUCT USE1POUCHPOUCHORAL2mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-09T08:00:012019-07-09T08:30:01
35ALCS-REG-STUDYEXALCS-REG-STUDY_1000214PRODUCT GUNCONTROLLED PRODUCT USE2.69gQUIDORAL4mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-09T14:06:242019-07-09T14:30:16
36ALCS-REG-STUDYEXALCS-REG-STUDY_1000215PRODUCT GUNCONTROLLED PRODUCT USE3.3gQUIDORAL4mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-09T14:49:392019-07-09T15:15:16
37ALCS-REG-STUDYEXALCS-REG-STUDY_1000216PRODUCT GCONTROLLED PRODUCT USE2gQUIDORAL4mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-10T08:00:002019-07-10T08:30:00
38ALCS-REG-STUDYEXALCS-REG-STUDY_1000217PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-10T14:02:072019-07-10T14:35:40
39ALCS-REG-STUDYEXALCS-REG-STUDY_1000218PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-10T15:27:372019-07-10T15:58:24
40ALCS-REG-STUDYEXALCS-REG-STUDY_1000219PRODUCT ACONTROLLED PRODUCT USE1POUCHPOUCHORAL8mg17DAY 7/EARLY TERMINATION7
TREATMENT
PRODUCT EXPOSURE2019-07-11T08:00:002019-07-11T08:30:00