Versions Compared

Key

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

...

A Product Accountability domain was submitted to represent dispensed and returned amounts. Each cartridge had a uniquely assigned number. This unique number was represented in DAREF. Multiple cartridges were dispensed at weekly visits, but each cartridge was tracked. At each weekly visit, all previously dispended cartridges were returned, and new cartridges dispensed.  Cartridges were always  replaced at the each visit.   DADTC are the visit dates when the cartridge was returned or dispensed.  Cartridges not used were record as having the full volume returned.    

Dataset wrap
Dataset2
RowSTUDYIDDOMAINUSUBJIDDASEQDAREFDATESTCDDATESTDACATDAORRESDAORRESUDASTRESCDASTRESNDASTRESUVISITNUMDADTC
1ABCDAABC-01001

1

CRT8754DISPAMTDispensed AmountSTUDY PRODUCT8CONTAINERmL88mL12004-06-26
2ABCDAABC-01001

2

CRT8768DISPAMTDispensed AmountSTUDY PRODUCT8CONTAINERmL88mL12004-06-26
3ABCDAABC-01001

3

CRT8769DISPAMTDispensed AmountSTUDY PRODUCT8CONTAINERmL88mL12004-06-26
4ABCDAABC-01001

4

CRT8754RETAMTReturned AmountSTUDY PRODUCT2CONTAINERmL66mL22020-07-06
2ABCDAABC-01001

5

CRT8768RETAMTReturned AmountSTUDY PRODUCT1.6CONTAINERmL88mL22020-07-06
3ABCDAABC-01001

6

CRT8769RETAMTReturned AmountSTUDY PRODUCT8CONTAINERmL88mL22020-07-06
5ABCDAABC-01001

7

CRT9756DISPAMTDispensed AmountSTUDY PRODUCT8CONTAINERmL 88mL22020-07-06
6ABCDAABC-01001

8

CRT9756RETAMTReturned AmountSTUDY PRODUCT1.0CONTAINERmL1.31.3mL32020-07-10

 Since the data in Exposure as collected (EC) would be practically identically to the summarized EX domain, the sponsor did not submit the EC domain. The sponsor unblinded the study before creating the EX domain. The unblinded product name is provided in EXTRT, here a dummy name is used for the tobacco product.  

...