Example Case Report Forms for FA domain
Sources: DB1 | Forms loaded: 6
Form: Adverse Events
Show domain info
Primary Domain
AE
All Domains
AE, FA
# Question Response
1
Adverse Event Verbatim
field_001
2
Event Category
field_002
3
Did the event start before administering first dose of study medication?
field_003
4
Date Started
field_004
5
Event ongoing?
field_005
6
Date Ended
field_006
7
Severity of the Event
field_007
8
Event Related to Study Drug
field_008
9
Toxicity Grade of the Event (CTCAE)
field_009
10
Action Taken with Study Drug because of Adverse Event
field_010
11
Other action taken?
field_011
12
Serious Event?
field_012
13
Resulted in Death?
field_013
14
Immediately Life Threatening?
field_014
15
Required Hospitalization or Prolonged Hospitalization?
field_015
16
If hospitalized, 
field_016
17
date of hospitalization
field_017
18
Time of hospitalization
field_018
19
If hospitalized, 
field_019
20
date of discharge
field_020
21
Time of discharge
field_021
22
Persistent or Significant Disability?
field_022
23
Congenital Anomaly/Birth Defect?
field_023
24
Other Medically Important Serious Event?
field_024
25
Outcome of the Event?
field_025
26
Was the event adjudicated
field_026
27
Adjudication Result
field_027
28
Relationship to Non-Study Treatment
field_028
Example Case Report Forms for FA domain
Sources: DB1 | Forms loaded: 6
Form: Falls
Show domain info
Primary Domain
CE
All Domains
CE, FA
# Question Response
1
Did the patient fall since last visit?
field_001
2
Date of fall
field_002
3
Time of the day
field_003
4
Environment (of fall)
field_004
5
Activity at the time of fall
field_005
6
Fall Mechanism
field_006
7
Did the fall result in injury
field_007
8
Severity of the injury
field_008
9
field_009
Example Case Report Forms for FA domain
Sources: DB1 | Forms loaded: 6
Form: Ce Hypoglyc
Show domain info
Primary Domain
CE
All Domains
CE, FA
# Question Response
1
Did subject have any hypoglycemic events since the last visit?
field_001
2
Sequence Identifier
field_002
3
Hypoglycemic event start date
field_003
4
Hypoglycemic event start time
field_004
5
What was the date of last study treatment before the event?
field_005
6
What was the time of last study treatment before the event?
field_006
7
What was the subject's awareness of the hypoglycemic event?
field_007
8
Blood glucose concentration measured prior to treating the event?
field_008
9
If measured, what is the blood glucose concentration
field_009
10
Unit of blood glucose concentration measurement
field_010
11
Were signs/symptoms of hypoglycemia present, other than the blood glucose reading?
field_011
12
What was the hypoglycemic event outcome?
field_012
13
Specify if outcome is other
field_013
14
Was treatment given because of the occurrence of the event?
field_014
15
If yes, how was the hypoglycemic event treatment
field_015
16
field_016
Example Case Report Forms for FA domain
Sources: DB1 | Forms loaded: 6
Form: Hepatobiliary assessment form
Show domain info
Primary Domain
FA
All Domains
FA
# Question Response
1
Adverse Event Identifier
field_001
2
Has the subject recently received a blood transfusion or traveled to an
field_002
3
Does the subject have signs or symptoms consistent with Hepatitis?
field_003
4
Has the subject recently experienced occupational or toxic exposure?
field_004
5
Has the subject had a recent increase in alcohol use?
field_005
6
Has the subject had a recent increase in recreational drug use?
field_006
7
Have any local labs been performed that pertain to this event?
field_007
8
Indicate the most severe Hepatobiliary AESI experienced by the Subject.
field_008
9
Has there been a serological evaluation for viral hepatitis A, B, or C,
field_009
10
Has a gastrointestinal or hepatobiliary consult occurred?
field_010
11
Did the patient have any other additional required procedures?
field_011
12
If yes, Specify the other additional required procedures
field_012
13
field_013
Example Case Report Forms for FA domain
Sources: DB1 | Forms loaded: 6
Form: Injection Site Reaction
Show domain info
Primary Domain
FA
All Domains
FA
# Question Response
1
Date of assessment
field_001
2
Did the subject have any injection site reacion events?
field_002
3
What is the date of the injection?
field_003
4
What date did the injection site reaction start?
field_004
5
At what time did the injection site reaction start?
field_005
6
What date did the injection site reaction end?
field_006
7
At what time did the injection site reaction end?
field_007
8
Was there pain (including burning) at the injection site?
field_008
9
Was there itching at the injection site?
field_009
10
Was there a rash (or redness) at the injection site?
field_010
12
Was there an open sore at the injection site?
field_012
14
What was the anatomical location of the injection site reaction?
field_014
15
field_015
Example Case Report Forms for FA domain
Sources: DB1 | Forms loaded: 6
Form: Chronic Kidney Diseaase History
Show domain info
Primary Domain
FA
All Domains
FA, MH
# Question Response
1
Medical Condition
field_001
2
Date of diagnosis
field_002
3
Stage of Chronic Kidney Disease
field_003
4
What is the likely etiology of CKD?
field_004
5
field_005