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.

Review the list of requirements and make sure your study design complies with all of them. In case your study design doesn't meet a requirement, you can either update your study design to match the given configuration or modify the custom calculations used in the dashboard to match your study design. If you choose to modify the dashboard's custom calculations, keep in mind that all impacted custom calculations must be updated, and updates can only be made on a modifiable copy of the Subject Data Analysis dashboard template. For more details, see Create a modifiable copy of a template.

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

You can customize some visualizations in the Individual Subject Data report, so that you don't have to modify your study's design. The tables in this section describe how to modify custom calculations for the following visualizations:
  • 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.
  • Gender
  • Race
  • Date of Birth
  • Age
  • Date of Informed Consent
Update to match with your current form name when it is not named as "Demographics".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to FORM_NAME:
    FORM_NAME like 'Demographics'
  3. Replace 'Demographics' with your current form name.
    • Keep the single quotes.
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.
  • Gender
Update to match with your current question related to gender, when it doesn't contain the keyword "Gender".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Gender%'
  3. Replace '%Gender%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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.
  • Race
Update to match with your current question related to race, when it doesn't contain the keyword "Race".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Race%'
  3. Replace '%Race%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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 'Date of Birth' or 'Age' in their names.

  • Age
  • Date of Birth
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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Date of Birth%', or ITEM_NAME LIKE '%Age%' or ITEM_NAME LIKE '%Age_%'
  3. Replace '%Date of Birth%', '%Age%', or '%Age_%' with any keyword from your current questions.
    • Keep the single quotes and percentage signs (%).
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 'Date of Informed Consent' in their names.

  • Date of Informed Consent
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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Date of Informed Consent%'
  3. Replace '%Date of Informed Consent%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).

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.
  • Condition
  • Ongoing?
  • Start Date
  • Resolved Date
Update to match with your current form name when it is not named as "Medical History Records".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to FORM_NAME:
    FORM_NAME like 'Medical History Records'
  3. Replace 'Medical History Records' with your current form name.
    • Keep the single quotes.
ITEM_NAME must contain the string 'Condition'.

The form question used to collect data on a subject's condition must contain the word 'Condition'.

  • Condition
Update to match with your current question related to a subject's condition when the question doesn't contain the word "Condition".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Condition%'
  3. Replace '%Condition%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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 'Ongoing?'.

  • Ongoing?
Update to match with your current question related to a subject's condition when the question doesn't contain the word "Ongoing".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Ongoing%'
  3. Replace '%Ongoing%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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 'Start Date'.

  • Start Date
Update to match with your current question related to a subject's condition when the question doesn't contain the words "Start Date".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Start Date%'
  3. Replace '%Start Date%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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 'Resolved Date'.

  • Resolved Date
Update to match with your current question related to a subject's condition when the question doesn't contain the words "Resolved Date".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Resolved Date%'
  3. Replace '%Resolved Date%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).

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.
  • Body system
  • Evaluation
Update to match with your current form name when it is not named as "Physical Examination".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    FORM_NAME LIKE 'Physical Examination' or 
    CASE WHEN FORM_NAME = 'Physical Examination'
  3. Replace 'Physical Examination' with any keyword from your current question.
    • Keep the single quotes.
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 'Body System'.

  • Body System
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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Body system%'
  3. Replace '%Body system%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the string 'Evaluation'.

The form question used to determine the type of evaluation of a subject must contain the word 'Evaluation'.

  • Evaluation
Update to match with your current question related to a subject's analyzed body system when the question doesn't contain thr words "Evaluation".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Evaluation%'
  3. Replace '%Evaluation%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).

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.
  • Weight
  • Pulse
  • Respiratory rate
  • Temperature
  • Unit
  • Systolic
  • Diastolic
Update to match with your current form name when it doesn't contain the "Vital Signs'" string as part of it.
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to FORM_NAME:
    FORM_NAME LIKE 'Vital Signs' or 
    CASE WHEN FORM_NAME = 'Vital Signs'
  3. Replace 'Vital Signs' with any keyword from your current question.
    • Keep the single quotes.
ITEM_NAME must contain the string 'Weight'.

The form question used to determine a subject's weight must contain the word 'Weight'.

  • Weight
Update to match with your current question related to a subject's weight when the question doesn't contain the word "Weight".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Weight%'
  3. Replace '%Weight%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the string 'Pulse'.

The form question used to determine a subject's pulse rate must contain the word 'Pulse'.

  • Pulse
Update to match with your current question related to a subject's pulse rate when the question doesn't contain the word "Pulse".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Pulse%'
  3. Replace '%Pulse%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the string 'Respiratory rate'.

The form question used to determine a subject's respiratory rate must contain the words 'Respiratory rate'.

  • Respiratory rate
Update to match with your current question related to a subject's respiratory rate when the question doesn't contain the words "Respiratory rate".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Respiratory rate%'
  3. Replace '%Respiratory rate%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the string 'Temperature'.

The form question used to determine a subject's temperature must contain the word 'Temperature'.

  • Temperature
Update to match with your current question related to a subject's body temperature when the question doesn't contain the words "Temperature".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Temperature%'
  3. Replace '%Temperature%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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 'Unit'.

  • Unit
Update to match with your current question related to a subject's vital signs unit when the question doesn't contain the words "Unit".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Unit%'
  3. Replace '%Unit%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the string 'Systolic'.

The form question used to determine a subject's systolic blood pressure must contain the word 'Systolic'.

  • Systolic
Update to match with your current question related to a subject's systolic blood pressure when the question doesn't contain the words "Systolic".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Systolic%'
  3. Replace '%Systolic%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the string 'Diastolic'.

The form question used to determine a subject's diastolic blood pressure must contain the word 'Diastolic'.

  • Diastolic
Update to match with your current question related to a subject's diastolic blood pressure when the question doesn't contain the words "Diastolic".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Diastolic%'
  3. Replace '%Diastolic%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).

AE (Adverse Event) and CM (Concomitant Medication) Data

You can customize some visualizations in the AE & CM Data report, so that you don't have to modify your study's design. The tables in this section describe how to modify custom calculations for the following visualizations:
  • 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.
  • Adverse Event
  • Severity
  • Start date
  • Ongoing?
  • End date
  • Any related medication?
  • Serious
  • Outcome
  • PT
  • SOC
Update to match with your current form name when it is not named as "Adverse Event".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to FORM_NAME:
    FORM_NAME like 'Adverse Event'
  3. Replace 'Adverse Event' with your current form name.
    • Keep the single quotes.
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 'Adverse Event'.

  • Adverse Event
Update to match with your current question related to a subject's adverse event when the question doesn't contain the words "Adverse Event".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Adverse Event%'
  3. Replace '%Adverse Event%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Severity%'
  3. Replace '%Severity%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Start date%'
  3. Replace '%Start date%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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?'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Ongoing%'
  3. Replace '%Ongoing%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%End date%'
  3. Replace '%End date%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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?'.
  • 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?".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Any related medication?%'
  3. Replace '%Any related medication?%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Serious%'
  3. Replace '%Serious%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • Outcome
Update to match with your current question related to outcome of an adverse event when the question doesn't contain the word "Outcome".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Outcome%'
  3. Replace '%Outcome%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the word 'PT'. The form question used to collect data on the PT must contain the acronym 'PT'.
  • PT
Update to match with your current question related to physical therapy when the question doesn't contain the acronym"PT".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%PT%'
  3. Replace '%PT%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
ITEM_NAME must contain the word 'SOC'. The form question used to collect data on the SOC must contain the acronym 'SOC'.
  • SOC
Update to match with your current question related to the standard of care when the question doesn't contain the acronym"SOC".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%SOC%'
  3. Replace '%SOC%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).

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.
  • Medication name
  • Start date
  • Stop date
  • Route
  • Ongoing?
  • Indication
  • Frequency
  • Form
  • Dose or unit
  • ATC 1
  • ATC 4
Update to match with your current form name when it is not named as "Prior and Concomitant Medication".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to FORM_NAME:
    FORM_NAME like 'Prior and Concomitant Medication'
  3. Replace 'Prior and Concomitant Medication' with your current form name.
    • Keep the single quotes.
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 'Medication name'.

  • Medication name
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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    AND LOWER(ITEM_NAME) LIKE '%medication name%'
  3. Replace '%medication name%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • Start date
  • CM Day
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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Start date%'
  3. Replace '%Start date%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Stop date%'
  3. Replace '%Stop date%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Route%'
  3. Replace '%Route%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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?'.
  • 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?".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Ongoing?%'
  3. Replace '%Ongoing?%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • Indication
Update to match with your current question related to the indication of a medication when the question doesn't contain the string "Indication".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Indication%'
  3. Replace '%Indication%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Frequency%'
  3. Replace '%Frequency%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • Form
Update to match with your current question related to a form when the question doesn't contain the word"Form".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Form%'
  3. Replace '%Form%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • Dose
  • 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'.
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Dose%' or '%Dose unit%'
  3. Replace '%Dose%' or '%Dose unit%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • ATC1
Update to match with your current question when the question doesn't contain the acronym"ATC1".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%ATC1%'
  3. Replace '%ATC1%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • ATC4
Update to match with your current question when the question doesn't contain the acronym"ATC4".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%ATC4%'
  3. Replace '%ATC4%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).

Lab Data

You can customize some visualizations in the Lab Data report, so that you don't have to modify your study's design. The table in this section describe how to modify custom calculations for the following visualizations:
  • 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:
  • 'Cardiac Biomarkers (Central Labs)'
  • Biochemistry
  • Hematology
The form used in your study to collect lab data must be called either:
  • 'Cardiac Biomarkers (Central Labs)'
  • Biochemistry
  • Hematology

Note:

This form must contain all of the questions listed in this table.
  • Medication name
  • Start date
  • Stop date
  • Route
  • Ongoing?
  • Indication
  • Frequency
  • Form
  • Dose or unit
  • ATC 1
  • ATC 4
Update to match with your current form name when it is not named as "Cardiac Biomarkers (Central Labs), "Biochemistry", or "Hematology".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to FORM_NAME:
    FORM_NAME like 'Cardiac Biomarkers (Central Labs)', 'Biochemistry', 'Hematology'
  3. Replace any of the form title instances mentioned in the code block above with your current form name.
    • Keep the single quotes.
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Lab Test%'
  3. Replace '%Lab Test%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Lab Result%'
  3. Replace '%Lab Result%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Lab Unit%'
  3. Replace '%Lab Unit%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%High Range%'
  3. Replace '%High Range%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).
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'.
  • 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".
  1. On the data panel on the left, right-click the calculation under the My Calculations folder, and select Edit Calculation....
  2. In the Edit Calculation dialog, locate the line referring to ITEM_NAME:
    ITEM_NAME LIKE '%Low Range%'
  3. Replace '%Low Range%' with any keyword from your current question.
    • Keep the single quotes and percentage signs (%).