CRF Tracking/Review Forms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Institution name, Identifier
Item
Center Number
integer
C1301943 (UMLS CUI [1,1])
C0600091 (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])
Item Group
CRF Tracking/Review Form
C3889409 (UMLS CUI-1)
Item
Module
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Module
Code List
Module
CL Item
MOD1 (1)
CL Item
MOD2 (2)
CL Item
MOD3 (3)
CL Item
MOD4 (4)
CL Item
MOD5 (5)
CL Item
MOD6 (6)
CL Item
MOD7 (7)
CL Item
MOD8 (8)
CL Item
MOD9 (9)
CL Item
MOD10 (10)
Item
Module Description
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
C0678257 (UMLS CUI [1,3])
Clinical Trial Regulatory Tracking Document, Module
Code List
Module Description
CL Item
Screening/Course 1 (1)
CL Item
Course 2 (2)
CL Item
Course 3 (3)
CL Item
Course 4 (4)
CL Item
Course 5 (5)
CL Item
Course 6 (6)
CL Item
Course 7 (7)
CL Item
Course 8 (8)
CL Item
Course 9 (9)
CL Item
Course 10 (10)
Item
Page Range
text
C3889409 (UMLS CUI [1,1])
C1704732 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Module
Code List
Page Range
CL Item
1-29 (1)
CL Item
30-45 (2)
CL Item
30-45 (3)
CL Item
30-45 (4)
CL Item
30-45 (5)
CL Item
30-45 (6)
CL Item
30-45 (7)
CL Item
30-45 (8)
CL Item
30-45 (9)
CL Item
30-45 (10)
Item
Modules
text
C3889409 (UMLS CUI [1,1])
C1709061 (UMLS CUI [1,2])
Clinical Trial Regulatory Tracking Document, Module
Code List
Modules
CL Item
Sent to DM (1)
CL Item
Unused (2)
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, Submission, Date in time
Item
Date Submitted
date
C3889409 (UMLS CUI [1,1])
C1515022 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
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