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. Subject . All products contain nicotine except for product F, which was a nicotine-/tobacco-free product. 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.    . Subjects were confined to the site. Products were supplied to the subjects as needed by site staff. Each usage was recorded. The applicant did not submit a DA domain, nor an EC domain. The name of the actual product would be used, but a dummy name is used in this example.            

Dataset wrap
NameECEx
Dataset2
RowSTUDYIDDOMAINUSUBJID
ECSEQ
EXSEQ
ECTRT
EXTRT
ECCAT
EXCAT
ECDOSE
EXDOSE
ECDOSU
EXDOSUEXDOSFRMEXROUTE
ECDOSFRQ
EXPSTRG
EXROUTE
EXPSTRGUVISITNUMVISIT
VISITDY 
VISITDYEPOCH
ECSTDTC
EXSTDTC
XEENDTC
EXENDTC
1ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100011PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL6
ORAL
mg10DAY -1-1
TREATMENT
PRODUCT EXPOSURE2019-06-27T13:10:332019-06-27T13:38:49
2ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100012PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
6
ORAL
mg10DAY -1-1
TREATMENT
PRODUCT EXPOSURE2019-06-27T14:29:132019-06-27T14:54:53
3ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100013PRODUCT CCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL6
ORAL
mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-06-28T08:00:122019-06-28T08:30:21
4ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100014PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL4
ORAL
mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-06-28T14:01:522019-06-28T14:55:27
5ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100015PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL4
ORAL
mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-06-28T15:18:352019-06-28T15:57:33
6ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100016PRODUCT ECONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
4
ORAL
mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-06-29T08:00:082019-06-29T08:30:13
7ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100017PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
2
ORAL
mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-06-29T14:01:502019-06-29T14:50:11
8ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100018PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL2
ORAL
mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-06-29T15:24:332019-06-29T15:59:46
9ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
100019PRODUCT BCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
2
ORAL
mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-06-30T08:00:002019-06-30T08:30:00
10ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000110PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL6
ORAL
mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-06-30T14:12:322019-06-30T14:47:47
11ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000111PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
6
ORAL
mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-06-30T15:24:462019-06-30T16:04:57
12ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000112PRODUCT DCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
6
ORAL
mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-01T08:00:002019-07-01T08:30:00
13ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000113PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL8
ORAL
mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-01T14:02:362019-07-01T14:47:33
14ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000114PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
8
ORAL
mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-01T15:37:452019-07-01T15:58:15
15ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000115PRODUCT ACONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL8
ORAL
mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-02T08:00:002019-07-02T08:30:01
16ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000116PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL0
ORAL
mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-02T14:11:002019-07-02T14:54:08
17ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000117PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL0
ORAL
mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-02T15:38:522019-07-02T15:59:50
18ALCS-REG-STUDY
Ec
EXALCS-REG-STUDY_
10001 
1000118PRODUCT FCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
0
ORAL
mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-03T08:00:002019-07-03T08:30:00
19ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000119PRODUCT GUNCONTROLLED PRODUCT USE3.37gQUIDORAL
ONCE
4
ORAL
mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-03T14:13:142019-07-03T14:57:40
20ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000120PRODUCT GUNCONTROLLED PRODUCT USE3.2gQUID
ONCE
ORAL4
ORAL
mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-03T15:35:012019-07-03T16:07:25
21ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_
10001 
1000121PRODUCT GCONTROLLED PRODUCT USE2gQUIDORAL
ONCE
4
ORAL
mg17DAY 7/EARLY TERMINATION7
TREATMENT
PRODUCT EXPOSURE2019-07-04T08:00:042019-07-04T08:30:05
22ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100021PRODUCT EUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL8
ORAL
mg10DAY -1-1
TREATMENT
PRODUCT EXPOSURE2019-07-04T14:06:092019-07-04T14:14:14
23ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100022PRODUCT ECONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL8
ORAL
mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-07-05T08:00:002019-07-05T08:30:00
24ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100023PRODUCT DUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
4
ORAL
mg11DAY 11
TREATMENT
PRODUCT EXPOSURE2019-07-05T14:02:392019-07-05T14:18:57
25ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100024PRODUCT DCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL4
ORAL
mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-07-06T08:00:002019-07-06T08:30:00
26ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100025PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
6
ORAL
mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-07-06T14:00:002019-07-06T14:08:40
27ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100026PRODUCT CUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
6
ORAL
mg12DAY 22
TREATMENT
PRODUCT EXPOSURE2019-07-06T15:52:532019-07-06T15:59:21
28ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100027PRODUCT CCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL6
ORAL
mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-07-07T08:00:002019-07-07T08:30:00
29ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100028PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL2
ORAL
mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-07-07T14:01:122019-07-07T14:12:25
30ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_100029PRODUCT FUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL0
ORAL
mg13DAY 33
TREATMENT
PRODUCT EXPOSURE2019-07-07T14:57:492019-07-07T15:07:07
31ALCS-REG-STUDY
EC
EXALCS-REG-STUDY_1000210PRODUCT FCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
0
ORAL
mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-08T08:00:002019-07-08T08:30:00
32ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000211PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL0
ORAL
mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-08T14:00:522019-07-08T14:17:31
33ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000212PRODUCT BUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
2
ORAL
mg14DAY 44
TREATMENT
PRODUCT EXPOSURE2019-07-08T14:46:072019-07-08T14:53:43
34ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000213PRODUCT BCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
2
ORAL
mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-09T08:00:012019-07-09T08:30:01
35ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000214PRODUCT GUNCONTROLLED PRODUCT USE2.69gQUID
ONCE
ORAL4
ORAL
mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-09T14:06:242019-07-09T14:30:16
36ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000215PRODUCT GUNCONTROLLED PRODUCT USE3.3gQUIDORAL
ONCE
4
ORAL
mg15DAY 55
TREATMENT
PRODUCT EXPOSURE2019-07-09T14:49:392019-07-09T15:15:16
37ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000216PRODUCT GCONTROLLED PRODUCT USE2gQUID
ONCE
ORAL4
ORAL
mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-10T08:00:002019-07-10T08:30:00
38ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000217PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
8
ORAL
mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-10T14:02:072019-07-10T14:35:40
39ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000218PRODUCT AUNCONTROLLED PRODUCT USE1POUCHPOUCHORAL
ONCE
8
ORAL
mg16DAY 66
TREATMENT
PRODUCT EXPOSURE2019-07-10T15:27:372019-07-10T15:58:24
40ALCS-REG-STUDY
XE
EXALCS-REG-STUDY_1000219PRODUCT ACONTROLLED PRODUCT USE1POUCHPOUCH
ONCE
ORAL8
ORAL
mg17DAY 7/EARLY TERMINATION7
TREATMENT
PRODUCT EXPOSURE2019-07-11T08:00:002019-07-11T08:30:00