Study Coordinating Center, Identification number
Item
Center number
integer
C2825181 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Person Initials
Item
Patient Initials
text
C2986440 (UMLS CUI [1])
Investigator Name
Item
Investigator
text
C2826892 (UMLS CUI [1])
Clinical Trial Regulatory Tracking Document, Trial Screening, Failed
Item
Screening failure (archive only)
boolean
C3889409 (UMLS CUI [1,1])
C1710477 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Item
Module
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
Item
Module Description
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Code List
Module Description
CL Item
Screening/Course 1 (1)
CL Item
Serious Adverse Experiences (2)
CL Item
Serious Adverse Experiences (3)
CL Item
Serious Adverse Experiences (4)
CL Item
Serious Adverse Experiences (5)
CL Item
Serious Adverse Experiences (6)
CL Item
Post-Study Minimal FU M3 (8)
CL Item
Post-Study Minimal FU M6 (9)
CL Item
Post-Study Minimal FU M9 (10)
CL Item
Post-Study Minimal FU M12 (11)
CL Item
Post-Study Minimal FU M15 (12)
CL Item
Post-Study Minimal FU M18 (13)
CL Item
Post-Study Minimal FU M21 (14)
CL Item
Post-Study Minimal FU M324 (15)
CL Item
Post-Study Minimal FU M___ (16)
CL Item
Post-Study Minimal FU M___ (17)
Item
Page Range
text
C3889409 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1514721 (UMLS CUI [1,3])
Item
Modules
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
C1519246 (UMLS CUI [1,3])
Clinical Trial Regulatory Tracking Document, Page, Missing
Item
Missing pages (if applicable)
text
C3889409 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
C1705492 (UMLS CUI [1,3])
Clinical Trial Regulatory Tracking Document, Comment
Item
Site Monitor's comments (e.g. protocol violations or deviations)
text
C3889409 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Investigator Signature
Item
Site Monitor's signature
text
C3889409 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Investigator Signature, Date in time
Item
Date Submitted
date
C3889409 (UMLS CUI [1,1])
C2346576 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])