Required configuration for the Subject Data Analysis dashboard
The Subject Data Analysis dashboard is closely related to the design of a
study. This means that special configurations are needed in a form's design for some
visualizations to work properly. These configurations include specific form names
(FORM_NAME
) and question names
(ITEM_NAME
).
Most of the visualizations in the Subject Data Analysis dashboard use custom calculations to specify which form and question is used to get data to display. For this reason, your form names, questions, and even code list values must match with the specified values in the dashboard template's custom calculations.
Note:
Updating the custom calculations requires a basic understanding of programming. Reach out to your study manager for further assistance.Required configurations for the Subject Data Analysis dashboard
Tip:
If your study doesn't use a question listed in this table, there is no need for you to modify anything. The impacted visualizations will still be part of the dashboard and show a No Data Found message, which you can simple ignore. If you prefer, you can also delete the given visualization from your copy to get rid of the empty spaces.Individual Subject Data
- Subject Information (Listing Table)
- Medical History Records (Listing Table)
- Physical Examination (Listing Table)
- Vital Signs Detailed Report (Listing Table)
- Vital Signs
Table 4-7 Subject Information (Listing Table)
Configuration requirement | Description | Impacted custom calculations | How to update the custom calculation |
---|---|---|---|
FORM_NAME must be
'Demographics' . |
The form used in your study to collect demographic
data must be called
Demographics .
Note: This form must contain all of the questions listed in this table. |
|
Update to match with your current form name when it is not
named as "Demographics".
|
ITEM_NAME must contain the word
'Gender' . |
The form question used to collect data related to gender must
have the word 'Gender' in its name.
|
|
Update to match with your current question related to gender,
when it doesn't contain the keyword "Gender".
|
ITEM_NAME must contain the word
'Race' . |
The form question used to collect data related to race must have
the word 'Race' in its name.
|
|
Update to match with your current question related to race,
when it doesn't contain the keyword "Race".
|
ITEM_NAME must contain the string
'Date of Birth' or
'Age' . |
The form question used to collect data related to a
subject's age or date of birth must have the words |
|
Update to match with your current questions related to age or
the date of birth, when the questions don't contain the words
"Date of Birth" or "Age".
|
ITEM_NAME must contain the string
'Date of Informed Consent' . |
The form question used to collect data related to a
subject's age or date of birth must have the words |
|
Update to match with your current question related to the date
of the informed consent, when the question doesn't contain the
words "Date of Informed Consent".
|
Table 4-8 Medical History Records (Listing Table)
Configuration requirement | Description | Impacted custom calculations | How to update the custom calculation |
---|---|---|---|
FORM_NAME must be
'Medical History Records' . |
The form used in your study to collect data on a
subject's medical history must be called
Medical
History Records .
Note: This form must contain all of the questions listed in this table. |
|
Update to match with your current form name when
it is not named as "Medical History Records".
|
ITEM_NAME must contain the string
'Condition' . |
The form question used to collect data on a subject's
condition must contain the word
|
|
Update to match with your current question related
to a subject's condition when the question doesn't contain the
word "Condition".
|
ITEM_NAME must contain the
string 'Ongoing' . |
The form question used to determine whether a
subject's condition is ongoing or not must contain the word
|
|
Update to match with your current question
related to a subject's condition when the question doesn't
contain the word "Ongoing".
|
ITEM_NAME must contain the
string 'Start Date' . |
The form question used to determine the start date of
a subject's condition must contain the words |
|
Update to match with your current question
related to a subject's condition when the question doesn't
contain the words "Start Date".
|
ITEM_NAME must contain the
string 'Resolved Date' . |
The form question used to determine the day a
subject's condition is resolved must contain the words
|
|
Update to match with your current question related
to a subject's condition when the question doesn't contain the
words "Resolved Date".
|
Table 4-9 Physical Examination (Listing Table)
Configuration requirement | Description | Impacted custom calculations | How to update the custom calculation |
---|---|---|---|
FORM_NAME must contain the word
'Physical Examination' . |
The form used in your study to collect data on a
subject's physical exam must be called
Physical
Examination .
Note: This form must contain all of the questions listed in this table. |
|
Update to match with your current form name when
it is not named as "Physical Examination".
|
ITEM_NAME must contain the string
'Body System' . |
The form question used to determine the examined body
system of a subject must contain the words |
|
Update to match with your current question
related to a subject's analyzed body system when the question
doesn't contain the words "Body System".
|
ITEM_NAME must contain the string
'Evaluation' . |
The form question used to determine the type of
evaluation of a subject must contain the word
|
|
Update to match with your current question
related to a subject's analyzed body system when the question
doesn't contain thr words "Evaluation".
|
Table 4-10 Vital Signs Detailed Report (Listing Table) and Vital Signs
Configuration requirement | Description | Impacted custom calculations | How to update the custom calculation |
---|---|---|---|
FORM_NAME must be 'Vital
Signs' . |
The form used in your study to collect data on a
subject's vital signs must be called
Vital
Signs .
Note: This form must contain all of the questions listed in this table. |
|
Update to match with your current form name when
it doesn't contain the "Vital Signs'" string as part of
it.
|
ITEM_NAME must contain the string
'Weight' . |
The form question used to determine a subject's
weight must contain the word |
|
Update to match with your current question
related to a subject's weight when the question doesn't contain
the word "Weight".
|
ITEM_NAME must contain the string
'Pulse' . |
The form question used to determine a subject's pulse
rate must contain the word |
|
Update to match with your current question
related to a subject's pulse rate when the question doesn't
contain the word "Pulse".
|
ITEM_NAME must contain the string
'Respiratory rate' . |
The form question used to determine a subject's
respiratory rate must contain the words |
|
Update to match with your current question
related to a subject's respiratory rate when the question
doesn't contain the words "Respiratory rate".
|
ITEM_NAME must contain the string
'Temperature' . |
The form question used to determine a subject's
temperature must contain the word
|
|
Update to match with your current question
related to a subject's body temperature when the question
doesn't contain the words "Temperature".
|
ITEM_NAME must contain the string
'Unit' . |
The form question used to determine the unit of
measurement of a subject's vital signs must contain the word
|
|
Update to match with your current question
related to a subject's vital signs unit when the question
doesn't contain the words "Unit".
|
ITEM_NAME must contain the string
'Systolic' . |
The form question used to determine a subject's
systolic blood pressure must contain the word
|
|
Update to match with your current question
related to a subject's systolic blood pressure when the question
doesn't contain the words "Systolic".
|
ITEM_NAME must contain the string
'Diastolic' . |
The form question used to determine a subject's
diastolic blood pressure must contain the word
|
|
Update to match with your current question
related to a subject's diastolic blood pressure when the
question doesn't contain the words "Diastolic".
|
AE (Adverse Event) and CM (Concomitant Medication) Data
- Adverse Events (Listing Table)
- Prior and Concomitant Medication (Listing Table)
- Adverse Events
- Prior and Concomitant Medication
Table 4-11 Adverse Events (Listing Table) and Adverse Events
Configuration requirement | Description | Impacted custom calculations | How to update the custom calculation |
---|---|---|---|
FORM_NAME must be
'Adverse Event' . |
The form used in your study to collect adverse
events data must be called
Adverse
Event .
Note: This form must contain all of the questions listed in this table. |
|
Update to match with your current form name when
it is not named as "Adverse Event".
|
ITEM_NAME must contain the word
'Adverse Event' . |
The form question used to collect data on a subject's
adverse event must contain the words |
|
Update to match with your current question
related to a subject's adverse event when the question doesn't
contain the words "Adverse Event".
|
ITEM_NAME must contain the word
'Severity' . |
The form question used to collect data on the
severity of an adverse event must contain the words
'Severity' .
|
|
Update to match with your current question
related to the severity of an adverse event when the question
doesn't contain the word "Severity".
|
ITEM_NAME must contain the word
'Start date' . |
The form question used to collect data on the start
date of an adverse event must contain the words 'Start
date' .
|
|
Update to match with your current question
related to the start date of an adverse event when the question
doesn't contain the words "Start date".
|
ITEM_NAME must contain the word
'Ongoing' . |
The form question used to collect data on whether an
adverse event is ongoing or not must contain the words
'Ongoing?' .
|
|
Update to match with your current question
related to whether an adverse event is ongoing or not even when
the question doesn't contain the word "Ongoing".
|
ITEM_NAME must contain the word
'End Date' . |
The form question used to collect data on the end
date of an adverse event must contain the words 'End
Date' .
|
|
Update to match with your current question
related to the end date of an adverse event when the question
doesn't contain the words "End date".
|
ITEM_NAME must contain the string
'Any related medication?' . |
The form question used to collect data on any
related medication to an adverse event must contain the string
'Any related medication?' .
|
|
Update to match with your current question
related to any medication being related to an adverse event when
the question doesn't contain the string "Any related
medication?".
|
ITEM_NAME must contain the word
'Serious' . |
The form question used to collect data on the
seriousness of an adverse event must contain the word
'Serious' .
|
|
Update to match with your current question
related to the seriousness of an adverse event when the question
doesn't contain the string "Serious".
|
ITEM_NAME must contain the word
'Outcome' . |
The form question used to collect data on the
outcome of an adverse event must contain the word
'Outcome' .
|
|
Update to match with your current question
related to outcome of an adverse event when the question doesn't
contain the word "Outcome".
|
ITEM_NAME must contain the word
'PT' . |
The form question used to collect data on the PT
must contain the acronym 'PT' .
|
|
Update to match with your current question
related to physical therapy when the question doesn't contain
the acronym"PT".
|
ITEM_NAME must contain the word
'SOC' . |
The form question used to collect data on the SOC
must contain the acronym 'SOC' .
|
|
Update to match with your current question
related to the standard of care when the question doesn't
contain the acronym"SOC".
|
Table 4-12 Prior and Concomitant Medication (Listing Table) and Prior and Concomitant Medication
Configuration requirement | Description | Impacted custom calculations | How to update the custom calculation |
---|---|---|---|
FORM_NAME must be 'Prior
and Concomitant Medication' . |
The form used in your study to collect data on prior
and concomitant medication for a subject must be called
Prior and Concomitant
Medication .
Note: This form must contain all of the questions listed in this table. |
|
Update to match with your current form name when
it is not named as "Prior and Concomitant Medication".
|
ITEM_NAME must contain the words
'Medication name' . |
The form question used to collect data on the name of a subject's
medication must contain the words |
|
Update to match with your current question
related to the name of a subject's medication when the question
doesn't contain the string "Medication name".
|
ITEM_NAME must contain the words
'Start date' . |
The form question used to collect data on the start
date of a subject's administered medication must contain the words
'Start date' .
|
|
Update to match with your current question
related to the start date of a subject's administered medication
when the question doesn't contain the string "Start
date".
|
ITEM_NAME must contain the words
'Stop date' . |
The form question used to collect data on the stop
date of a subject's administered medication must contain the words
'Stop date' .
|
|
Update to match with your current question
related to the stop date of a subject's administered medication
when the question doesn't contain the string "Stop date".
|
ITEM_NAME must contain the word
'Route' . |
The form question used to collect data on route of
administration of a medication must contain the word
'Route' .
|
|
Update to match with your current question
related to the route of administration of a medication when the
question doesn't contain the string "Route".
|
ITEM_NAME must contain the word
'Ongoing?' . |
The form question used to collect data on whether
the administration of a certain medication is ongoing or not must
contain the word 'Ongoing?' .
|
|
Update to match with your current question
related to whether the administration of a medication is ongoing
or not when the question doesn't contain the string
"Ongoing?".
|
ITEM_NAME must contain the word
'Indication' . |
The form question used to collect data on the
indication of a medication must contain the word
'Indication' .
|
|
Update to match with your current question
related to the indication of a medication when the question
doesn't contain the string "Indication".
|
ITEM_NAME must contain the word
'Frequency' . |
The form question used to collect data on a
subject's frequency for taking medication must contain the word
'Frequency' .
|
|
Update to match with your current question
related to a subject's frequency for taking medication when the
question doesn't contain the string "Frequency".
|
ITEM_NAME must contain the word
'Form' . |
The form question used to collect data on a
subject's frequency for taking medication must contain the word
'Form' .
|
|
Update to match with your current question
related to a form when the question doesn't contain the
word"Form".
|
ITEM_NAME must contain the word
'Dose' or 'Dose
unit' . |
The form question used to collect data on the dosage
of a medication must contain the words 'Dose' or
'Dose unit' .
|
|
Update to match with your current question
related to the dosage of a medication when the question doesn't
contain the string "Dose" or 'Dose unit'.
|
ITEM_NAME must contain the string
'ATC1' . |
The form question used to collect data on a
subject's frequency for taking medication must contain the word
'ATC1' .
|
|
Update to match with your current question when
the question doesn't contain the acronym"ATC1".
|
ITEM_NAME must contain the string
'ATC4' . |
The form question used to collect data on a
subject's frequency for taking medication must contain the word
'ATC4' .
|
|
Update to match with your current question when
the question doesn't contain the acronym"ATC4".
|
Lab Data
- Cardiac Biomarkers (Central Labs) (Listing Table)
- Biochemistry (Listing Table)
- Hematology (Listing Table)
- Cardiac Biomarkers (Central Labs)
- Biochemistry
- Hematology
Table 4-13 Lab data
Configuration requirement | Description | Impacted custom calculations | How to update the custom calculation |
---|---|---|---|
FORM_NAME must be:
|
The form used in your study to collect lab data must
be called either:
Note: This form must contain all of the questions listed in this table. |
|
Update to match with your current form name when
it is not named as "Cardiac Biomarkers (Central Labs),
"Biochemistry", or "Hematology".
|
ITEM_NAME must contain the words
'Lab Test' . |
The form question used to collect data on a
subject's lab test must contain the words 'Lab
Test' .
|
|
Update to match with your current question
related to a subject's lab test when the question doesn't
contain the string "Lab Test".
|
ITEM_NAME must contain the words
'Lab Result' . |
The form question used to collect data on a
subject's lab results must contain the words 'Lab
Result' .
|
|
Update to match with your current question
related to a subject's lab results when the question doesn't
contain the string "Lab Result".
|
ITEM_NAME must contain the words
'Lab Unit' . |
The form question used to collect data on the unit
of measurement for a lab test must contain the word 'Lab
Unit' .
|
|
Update to match with your current question
related to a subject's lab unit when the question doesn't
contain the string "Lab Unit".
|
ITEM_NAME must contain the words
'High Range' . |
The form question used to collect data on a lab
test's high range value must contain the words 'High
Range' .
|
|
Update to match with your current question
related to a lab test's high range value when the question
doesn't contain the string "High Range".
|
ITEM_NAME must contain the words
'Low Range' . |
The form question used to collect data on a lab
test's low range value must contain the words 'Low
Range' .
|
|
Update to match with your current question
related to a lab test's low range value when the question
doesn't contain the string "Low Range".
|
Parent topic: Subject Data Analysis dashboard