LSAC has an integrated Smart Search & Smart Suggestions functionality which is powered by Saama’s proprietary Deep Learning Intelligent Assistant (DaLIA). 

DaLIA Videos:

The Smart Search bar is located at the top of your LSAC page:


Keyword Based Search & Suggestive Questions

From the Smart Search bar, you can start typing the name of any supported LSAC objects (see below) and see relevant auto-suggestive keywords (relevant to the data in the application) as you type. 

Based on your query, you can see some relevant suggestive questions in the DaLIA search box dropdown that you may choose from. Once you find the desired query, you can press Enter and launch it directly. 

DaLIA-Powered Search & Suggestions

DaLIA is trained to understand and answer questions, in English, in the clinical development domain. It complements the power of packaged LSAC Analytics and Dashboards by allowing users to ask ad-hoc questions and get specific answers without browsing a specific dashboard or KPI. 

Smart Search-Supported Objects

Out-of-the-Box Analytics
Data Review Sets
KPI Studio Reports
Quality Agreements
Dashboards (Out of the box & KPI Studio)
Folders
Monitors
DaLIA search queries

DaLIA: How it Works


Questions

DaLIA has been pre-trained using a deep learning algorithm to understand thousands of questions related to clinical development. Users can simply type a free text question in the Smart Search box.

Intent Recognition

Saama’s proprietary algorithm attempts to recognize the intent of user questions/queries, based on the information on which it’s been trained to understand. “count of sites for study Study ID/Name” and “list of oncology studies” are examples of DaLIA trained intents.

Entity Recognition

DaLIA can also parse entered text to identify specific entities, or parameters needed to compute results. For example, study names, study IDs, site names, site IDs, country names, and therapeutic areas (TA name) are entities that DaLIA provides auto-suggestive options to, depending on the study access defined for the user, from which the user can select the options that apply. Recognized entities are retained for related queries, as seen in the preset filters in the application front-end, till the time they are changed (based on query). 

Query Interpretation

Together, intent and entity recognition improve the accuracy of DaLIA answers/responses, which are drawn from the underlying data associated exclusively with your LSAC account. 

For example, the query “number of open queries for Study ABC99 in Australia” would be interpreted by DaLIA as:

Intent: Count_Queries

Entities: Study: ABC99; Country: Australia; Query_status: Open

Because DaLIA is trained on the same Unified Study Data Model (USDM) that feeds your LSAC analytic dashboards, the answers DaLIA provides will be consistent with the metrics shown in individual dashboards. 

Query Results

The query results computed by DaLIA are shown to the user in the workspace. You may see a summary card along with listing, or a listing only. The entities will be visible under Filters. Navigation breadcrumbs will show the actual user query and the workspace will show the intent and corresponding results, as shown below.

The query results computed by DaLIA are shown to the user in the workspace. You may see a summary card along with listing, or a listing only. The entities will be visible under Filters. Navigation breadcrumbs will show the actual user query and the workspace will show the intent and corresponding results, as shown below.

Included columns in query results/DaLIA output based on the primary entity being queried upon, is mentioned below:

For Study, Country, Region level intents, the response will include the TA, Study Phase, Study Sponsor, Study Status, Investigator, CRO details.

For Site level intents, the DaLIA response will include the TA, Study Phase, Study Sponsor, Study Status, Investigator Name, CRA, CRO details.

For Subject level intents, the DaLIA response will include the Site Name and Study Status details.

Note: The user will download resultant data as a CSV file and not view the results in the application, if the query results exceed 25000 records.

Query results on Disposition events can be altered by making changes to the entities/intents captured, from the query, and presented as local filters. The Summary Cards and the Listings (received in query results) will get attuned to the changes in filter values to deliver new results as being mutually exclusive from the previous query results. The following local filters will impact query results and these are:

  • Study level queries: Study Name filter and Intent filter
  • Country/Region level queries: Country/Region filter and Intent filter
  • Site level queries: Site ID/Site Name filter and Intent filter
  • Subject level queries: Subject ID filter and Intent filter

Changes to time-frame intents (addition/deletion) will also change the query results.


Graphical Visualization

Queries related to the trend of adverse events over a period of time (weekly, monthly, and so on) will be answered as a high chart. The high chart will be rendered as a stacked column chart comprising of three stacked columns (depending on the query), and legend key. Hovering over the stacked column will reveal relevant AE data. The three stacked columns are described below: 


A. Three columns will be rendered for queries containing all the parameters (refer to the DaLIA Pre-trained Intents table) , namely, i) Seriousness (Serious & Non-Serious), ii) Relatedness to IP (Related & Non-Related, Incomplete Data), and iii) Combination of Seriousness & Relatedness to IP ( Five combinations).

B. A baseline/reference line will run through the graph, at specific points that indicate the average number of adverse events for that specific week/month/year. This baseline will be visible for AE trends related to the site/country/region and will not be visible for AE trends related to studies.

C. Time depiction on X-axis will be presented as such: For Weekly – week 1/month, Monthly – MMM-YYYY (default selection), Yearly – YYYY.

Queries related to the count or percentage count of adverse events will be answered as a pie/donut chart and a listing. The pie/donut chart may, at the maximum, 5 segments since the count of adverse events will be presented in 5 combinations, that is, Serious & Related, Serious & Non-Related, Non-Serious & Related, Non-Serious & Non-Related, and Incomplete Data (when relatedness is unknown or if data is incomplete). Hovering over the pie/donut chart will give more relevant details.

Users can switch over to the listing view, if needed.

Customized Views

The query results shown as listing will comprise of columns and rows.

Rows

The top row in the query result will always be ‘frozen’, that is, it will always be visible even when you scroll down.

Columns

The first three columns of DaLIA output or query output will be ‘freezed’ columns and will stay put on the left side, that is, the three columns will not change position even when you scroll to the right side. The default combination of the three ‘freezed’ columns can be modified by the user to choose a new set of three columns that would be ‘freezed’ in the result.

All columns will be visible until the user chooses to hide some of the columns from the query result. This is achieved by clicking on the Settings icon and unselecting the check boxes of the columns the user does not want to see. The user can choose to show or hide the columns in the DaLIA output as needed, so as to have a more focused result.

A search option or a column-level filter is visible under every column name and this enables the user to have a selective DaLIA output based on the search parameters specified in the search boxes.

Sorting Query Results

The multi-level sorting feature in DaLIA enables the user to select multiple columns, that are part of the query result, and arrange them in ascending/descending/alphabetical order so as to arrive at a sorted output determined by the sorting order specified for every column. Click on the sorting option that appears at the top right corner of the table. 

Recommended Questions

Along with the query results, the DaLIA workspace also puts forth a list of queries that the user may be interested in, in the Would you also like to see section that is found at the bottom of the workspace. Click on any of the queries and you will be able to see or drill-down to the desired result.

Related Analytics

Depending on the query, the DaLIA workspace shows a list of related analytics, if any, that are found relevant to the query asked. The ‘Related Analytics’ section is found at the bottom of the result workspace.

Note:
Sections ‘Related Analytics’ and ‘Would you also like to see’ are seen in the DaLIA result workspace, based on the user’s defined access to the application.

Combining Multiple Similar Entities 

Entities in the following domain can be combined to make a single query using the AND, OR, BUT, NOT operators. DaLIA response is delivered with count and a tabular listing. The domains that respond to multiple entities in a single query are:

  • Disposition  - Entities that can be combined are Screening & Enrollment
  • Quality Measures - Entities that can be combined are Protocol Deviations - Major & Minor
  • Safety - Entities that can be combined are of Adverse Events - Severity, Seriousness & Relatedness to IP
  • Safety - Entities that can be combined are of Concomitant Medication - Indication & Route of Administration
  • Site Productivity - Entities that can be combined are Query Resolution entities - Closed, Open, Answered, Cancelled.
  • Other entities that can be combined are Site Issues entities - Open, Closed, Responded, Not Responded
  • Site Activation - Entities that can be combined are Site Activation entities - Site activation count, site activation time.
    • At Site level: Planned Site Activation Time = Planned Site Activation Date -Site Selection Date (Actual Date)
    • At Study level: Mean (Average) site activation time calculated of all the sites in that study. Sites with value '0' are not considered.
    • At Country level: Mean (Average) site activation time calculated of all the sites in that country. Sites with value '0' are not considered.
    • At Region level: Mean (Average) site activation time calculated of all the sites present in that region. Sites with value '0' are not considered.

Export Options

Every query result computed by DaLIA can be exported or downloaded as a CSV file. The ‘Export Options’ section appears at the bottom of the result workspace.


DaLIA Log Reports

All user queries will be logged irrespective of whether the query yielded a response or not. A log/record is created when a user types a query in the DaLIA search box and presses the Enter key. A log report can be retrieved as a *.csv file by the LSAC admin only

To retrieve a DaLIA log report, click the face icon that appears at the top right corner of the application and select Audit Trail Reports. Under Audit Trail Reports, click DaLIA Audit Trail Report.

The columns seen in the DaLIA Audit Trail Report will be as follows:

  • User Email/User ID

  • Account ID

  • Time/Date of query as Timestamp

  • Queries/Questions Asked

  • Intent Identified

  • Entities Identified

  • Vote

  • Feedback


Feedback

You can rate our responses through the Thumbs Up-Thumbs Down icons that are on the top right of the workspace. This will help us teach DaLIA new ‘tricks’ and help us improve on our user experience.

  1. Query responses with a summary card and a listing
      


  1. Query response with a specific intent (enrollment %)


Note: The DaLIA filter pane also allows the user to change or clear the pre-selected filter entities and re-run the query for additional results.

Smart Suggestions by DaLIA

DaLIA increases the potential to make insightful decisions based on suggestions generated using AI, ML which is a much time-saver as it speeds up the data analysis by 60-70 percent for medical monitors.

Smart suggestions have been implemented on the SCE dashboard in Clinical Insights (Patient Profile). When the dashboard is selected, a side panel containing smart suggestions opens up, by default, on the dashboard. 

Any smart suggestion can be applied in the SCE dashboard as a filter story to achieve a more focused result. To do so, click Apply as Story that appears below the suggestion to see the parameters in the filter story bar. Click Apply to apply the filter story across all tabs of the SCE dashboard for a focused result.


A confidence score is assigned to every smart suggestion that reflects its (smart suggestion) reliability and correctness. The most reliable confident score is set as High.


Click the bulb icon that appears at the top right corner of the Smart Suggestions side panel to submit any ideas or suggestions that would help in its improvisation. Click Submit to send the idea/suggestion to the LSAC team.


If you have found the suggestion helpful, you can select the Thumbs Up button else you can select Thumbs Down button.


You can close the side panel, for later viewing, by clicking on the Cross button. In this case the Smart Suggestion pop-up will appear at the bottom of the dashboard and will show the count of unread smart suggestions, if the smart suggestions has not been clicked upon. When a user clicks on a smart suggestion, then it is considered as read.


By default, the DaLIA suggestions pop-up is enabled. However, a user can disable the DaLIA suggestions popup and then the icon will be visible but will be greyed. 

The DaLIA suggestions pop-up shows the count of unread suggestions. When a user clicks on a suggestion, it is considered as Read. The analyzed/read suggestions appear greyed. The count of unread suggestions will not be visible if DaLIA suggestions is disabled.



By default, the DaLIA suggestions pop-up as a side panel and as an icon at the bottom of the dashboard is enabled/active. However, a user can disable the DaLIA suggestions pop-up (as a side panel and as an active icon at the bottom of the dashboard) by disabling the toggle switch in the side panel. The count of unread suggestions will not be visible if DaLIA suggestions is disabled. 


All* suggestions gathered, based on the study of interest, are seen through the Smart Suggestions side panel that opens up, by default, when the Smart Clinical Explorer (SCE) dashboard is loaded. Disabling the Smart Suggestions toggle will:

  • Not show any new notifications on new suggestions.
  • Not open the Smart Suggestions side panel when the SCE dashboard is loaded.  

*All = As per the defined scope of suggestions in the application.

Note: 
  • All unread suggestions are shown as new notifications that appear on the Smart Suggestions icon located at the bottom right of the SCE dashboard.
  • The Smart Suggestions side panel opens only once when the SCE dashboard is loaded and will not open repeatedly as the user switches between the tabs of the SCE dashboard.




The Smart Suggestion pop-up and opening of the Smart Suggestions side panel (on loading of the dashboard) can be enabled again by enabling the toggle switch in the Smart Suggestions side panel.  


Methods used for Smart Suggestions

  1. Pattern recognition: The objective here is to identify and capture succinct unique patterns in clinical data and to be able to detect risk factors in the early phases of study. To analyze and extract meaningful information from complex clinical data, a powerful computing tool is necessary. ‘K-means clustering’ is a proving technique to identify such patterns.
  2. Correlation Analysis framework: Clinical data contains many correlations which might not be visible through the human eye, but some disposition events are highly correlated within the clinical data itself and these are unnoticeable by medical monitors, and it costs most of their time to identify the root of study failures.


Smart Suggestion Implemented


The Smart Suggestion window will be placed at the bottom right corner of the CIO dashboard and when the user selects it, it will show suggestions. As of now, DaLIA smart suggestions are implemented in the following domains:

  • Correlation analysis between Serious Adverse Events (AE) and early EOT
  • Correlation analysis between Inclusion/Exclusion Criteria and Enrollment
  • Correlation analysis between early EOT, Adverse Events (AE)/Exposure and Demographics
  • Correlation of Early EOT with new parameters, such as, Labs, VS, PE.
  • Predictions of Early EOT based on AE, Demographics and so on.
  • Predictions of AE based on Vital Signs and Demographics.
  • Correlation of Early EOT with AE and Demographics.
  • Correlation between Medical History (MH), Concomitant Medication (CM), Adverse Events (AE), and Early EOT.
  • Pattern identification between Serious drug-related AE, DM, CM, Labs, MH, and Early EOT.
  • Identifying subjects with possible combination of serious AE and CM.
  • Identifying subjects with possible combination of serious AE, CM and MH.

List of Pre-trained DaLIA (VA) Intents

#

Intent Name

Intent Description***

**Sample Questions

1

Count of Sites

Intent gives the count of sites which have more than X <query type> for <TA, Indication, Compound, Provider, study_id, query status, query cancelled, query opened time, query answered time, query resolved time, query closed time>

count of sites where more than/less than/maximum/minimum X queries are answered/open/closed/cancelled

2

Count of Studies

Intent gives the count of studies which have more than X <query type> for <TA, Indication, Compound, Provider, study_id, query status, query cancelled, query opened period, query answered period, query resolved period, query closed period>

count of studies where more than/less than/maximum/minimum X queries are answered/open/closed/cancelled

3

Count of Countries

Intent gives the count of countries which have more than X <query type> for <TA, Indication, Compound, Provider, study_id, query status, query cancelled, query opened period, query answered period, query resolved period, query closed period>

count of countries where more than/less than/maximum/minimum X queries are answered/open/closed/cancelled

4

Which – Sites

Which Sites have more than X queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Which sites have more than/less than/maximum/minimum X queries are answered/open/closed/cancelled for study [study ID/name]

5

Which – Studies

Intent gives Which Studies have the X queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Which studies have more than/less than/maximum/minimum X queries are answered/open/closed for Oncology

6

Which – Countries

Intent gives Which Countries have the X queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Which country have more than/less than/maximum/minimum X queries are answered/open/closed for study [ID/name]

7

Top 5 Sites

Intent gives Top 5 Sites that have the maximum queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Top 5 sites that have maximum queries opened/answered/ cancelled/ closed for Study [ID/name]

8

Top 5 – Studies

Intent gives Top 5 Studies that have all the maximum queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Top 5 studies that have maximum queries opened/answered/ cancelled/ closed for oncology/cancer

9

Top 5 – Countries

Intent gives Top 5 Countries that have all the maximum queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query cancelled, query type, query opened period, query answered period, query resolved period, query closed period>

Top 5 countries for study [ID/name] that have maximum queries Opened/Answered/ Cancelled/ Closed

10

Bottom 5 Sites

Intent gives Bottom 5 Sites by minimum queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Bottom 5 sites that have minimum Opened/Answered/ Cancelled/ Closed queries for Study [ID/name]

11

Bottom 5 Studies

Intent gives Bottom 5 Studies by maximum queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Bottom 5 studies that have minimum Opened/Answered/ Cancelled/ Closed queries for oncology/ cancer

12

Bottom 5 Countries

Intent gives Bottom 5 Countries that have all the maximum queries resolved for <TA, Indication, Compound, Provider, study_id, query status, query cancelled,, query type, query opened period, query answered period, query resolved period, query closed period>

Bottom 5 countries for study [ID/name] that have minimum Opened/Answered/ Cancelled/ Closed queries

13

Query Resolution Time

Intent gives Query Resolution Time for one or multiple <study Id or Study name> intents/Query Resolution Time for one or multiple <country> intents/ Query Resolution Time for one or multiple < Site Id or Site name-XX> in <country-XX>/ Query Resolution Time for all Studies

Query Resolution Time for study [ID/name] OR Query Resolution Time for [country]

14

Query Resolution Count

Intent gives the query resolution count & listing of queries in different status by combining multiple entities by AND/OR /BUT operators

tell me open or closed query count for site [ID/name] in year YYYY/month OR tell me queries which were answered but not closed OR tell me queries which are open and/or answered for site[ID/name]/country/study[ID/name] in year/month OR tell me queries that are cancelled and/or closed for study[ID/name]/site[ID/name]/country in year/month

15

Query Answered Time

Intent gives What is the Query Answered Time for <TA, Indication, Compound, Provider, study_id, query status, query re-opened, query type, query opened period, query answered period, query resolved period, query closed period>

Query Answer Time for study [ID/name] OR Query Answer Time for study [ID/name] in [country] OR Query Answer Time for site [ID] OR Query Answer Time for all Studies

16

Open Query Rate

Intent gives Open query rate for Study, Region, country and Site

Query open rate for study [ID/name] OR Query open rate for study [ID/name] in [Region] OR Query open rate for study [ID/name] in [country] OR Query open rate for site [ID]

17

Count of Opened Queries

Intent gives Count of Opened Queries for Study, Region, country and Site.

Count of opened queries for TA/study [ID/name]/ country/ site ID.

Count of open queries for Study [ID/name] OR Count of opened queries for oncology in [country] OR Count of opened queries for oncology in [country] for study [ID/name] OR Count of open queries in [country] for study [ID/name] OR Count of open queries in site [ID] for study [ID/name]

Note: Count of Opened Queries is the summation of Open queries and Answered queries.

18

Count of Answered Queries

Intent gives Count of Answered Queries for Study, Region, country and Site

Count of Answered queries for [TA] / study [ID/name] / country / site [ID]. Count of Answered queries for Study [ID/name] OR Count of Answered queries in [country] for study [ID/name] OR Count of Answered queries in site [ID] for study [ID/name] OR Count of answered queries for oncology in [country] for study [ID/name]

19

Count of Closed Queries

Intent gives Count of Closed Queries for Study, Region, country and Site

Count of closed queries for [TA] / study [ID/name] / [country] / site [ID]. Count of closed queries for Study [ID/name] OR Count of closed queries for oncology in [country] for study [ID/name] OR Count of closed queries in [country] for study [ID/name] OR Count of closed queries in site [ID] for study [ID/name]

Note: Count of Closed Queries is the summation of Closed queries and the Cancelled queries.

20

Count of Cancelled Queries

Intent gives Count of Cancelled Queries for Study, Region, country and Site

Count of Cancelled queries for [TA] / study [ID/name] / country / site [ID] OR Count of Cancelled queries for Study [ID/name] OR Count of Cancelled queries in [country] for study [ID/name] OR Count of Cancelled queries in site [ID] for study [ID/name]

21

Total Query Count

Intent gives Total query count for Study/ Country/Site

Total query count for study [ID/name] OR Total query count for [country] OR Total query count for Site [ID]

Note: Total Query Count is a summation of queries that are open, closed, cancelled, and answered where the count of queries in column Closed includes the count of cancelled and answered queries as well.

22

Count of Studies (Milestone)

Intent gives Count of studies have achieved/planned <Milestone Name> with <days> delay/ahead

Studies which have achieved First patient In OR How many studies under Program [ID/name] are closed OR Studies achieved Data base lock

23

Count of Sites (Milestone)

Intent gives Count of sites have achieved/planned <Milestone Name> with <days> delay/ahead

Sites which have achieved 50% site activation OR Count of sites with first subject enrolled OR Sites of CRA [ID/name] with enrollment closed

24

Count of Countries (Milestone)

Intent gives Count of countries have achieved/planned <Milestone Name> with <days> delay/ahead

Countries which have achieved EC approval

25

When – Milestone

Intent gives When was the Milestone for study/ <Country, Site ID> achieved it will also give delay

When was the Last Milestone for study [ID/name] in [country] was achieved OR when was [milestone name] achieved for site [ID]

26

What -Milestone

Intent gives What milestone achieved by <Study ID> in <Site Id, Country> with X days delay

What is the first/last milestone achieved by study [ID/name] in Site [ID] in [country] with 10 days delay OR tell me Milestone achieved by site [ID] / study [ID/name]

27

Top N – Studies

Intent gives Top N Studies for <TA, Indication, Compound, Provider> where there is Minimum delay in achieving <Milestone Name>

Top 5 Studies which have achieved maximum milestones OR Top 5 studies which have achieved more than 3 milestone OR Top 5 studies which have achieved all the milestones

28

Top N – Countries

Intent gives Top N Countries for <TA, Indication, Compound, Provider> studies where there is Minimum delay in achieving <Milestone Name> in <Country>

Top 5 Countries which have achieved maximum milestones for study OR Top 5 countries which have achieved more than 3 milestone for study [ID/name] OR Top 5 countries which have achieved all the milestones for study [ID/name]

29

Top N -Sites

Intent gives Top N Sites <TA, Indication, Compound, Provider> studies by Minimum delay in achieving <Milestone Name> in <Country, Site ID>

Top 5 sites which have achieved maximum milestones for study or country OR Top 5 Sites which have achieved more than 3 milestone for study [ID/name] in [country] OR Top 5 sites which have achieved all the milestones for study [ID/name]

30

Bottom N – Studies

Intent gives Bottom 5 studies <TA, Indication, Compound, Provider> by Maximum delay in achieving <Milestone Name> in <Country, Site ID>

Bottom 5 Studies which have achieved minimum milestones OR Bottom 5 studies which have achieved less than 3 milestone

31

Bottom N -Countries

Intent gives Top N Sites for <TA, Indication, Compound, Provider> studies where there is Minimum delay in achieving <Milestone Name> in <Country>

Bottom 5 Countries which have achieved minimum milestones for study [ID/name] OR Bottom 5 countries which have achieved less than 3 milestone for study [ID/name]

32

Bottom N – Sites

Intent gives Top N Sites for <TA, Indication, Compound, Provider> studies where there is Minimum delay in achieving <Milestone Name> in <Country>

Bottom 5 sites which have achieved minimum milestones for study [ID/name] OR Bottom 5 Sites which have achieved more than 3 milestone in [country] for study [ID/name]

33

Which – List of Studies

Intent gives Which <TA, Indication, Compound, Provider, Country> studies has <all, milestone name>

List of studies OR which studies had achieved 100% Site Activation OR List of studies achieved 100% Site Activation

34

*Which – List of Milestones

Intent gives Which is the next/upcoming Milestone for Country, Site

List of upcoming milestone for NCTID in [Country/Site [ID]]

35

Which – List of Countries

Intent gives Which Countries have <Milestone> for Study ID achieved

Which country had achieved 100% Site activation for study [ID/name]

36

Which – List of Sites

Intent gives Which Sites in <Country> have <Milestone> for StudyID / <TA,Indication,PPD, Compound> studies achieved with a delay of X days

Which Site in [country] have achieved IRB approval with a delay of 15 days

37

Count – Screening (Screened, Screen Failed, Screen Passed)

Intent gives Count of Screening (Screened, Screen Failed, Screen Passed) for study, Region, Country and Site

Intent also gives count and listing for multiple disposition events (entities) combined with AND/OR/BUT/NOT operators

No. of subject screened for study [ID/name]/[region]/[country]/[site [ID]] OR No. of Screen failed for study [ID/name]/[Region]/[Country]/[Site [ID]] OR No. Subject Screen passed for study[ID/name]/[Region]/[Country]/[Site[ID]

screened and/or enrolled for study[ID/name]/site[ID/name]/country/region OR tell me subjects screened and/but not enrolled for study[ID/name]/site[ID/name]/country/region in year/month OR tell me subjects enrolled and randomized for study[ID/name]/country/site[ID/name]/region OR subjects enrolled and/or treatment not initiated in year/month OR subjects enrolled but not randomized for study[ID/name]/site[ID/name]/country/region

Note: Count is shown for first disposition event mentioned in BUT NOT intent. Count is shown for the second disposition even mentioned in AND intent. Count is mentioned for both the disposition events mentioned in OR intent. Listings show the details of both the disposition events.

38

Count – Enrollment

Intent gives Count of Enrollment for Study/Region/Country/Site

Count of Enrollment for study[ID/name]/[region]/[country]/site [ID]

39

Disposition Count – Studies

Intent gives Count of Subject disposition for study

Count of subjects Screened/Enrolled/Follow Up Agreed/Follow Up Not Agreed/Treatment Initiated/Treatment Not Initiated/Discontinued before Treatment/Discontinued after Treatment/Withdrawal of Consent/Withdrawn/Screened/Failed Screen/Consented/Randomized/Evaluable/Completed Treatment for study [ID/name]

40

Disposition Count – Countries

Intent gives count of subject disposition for country

Count of subjects Screened/Enrolled/Follow up agreed/Follow up not agreed/Treatment Initiated/Treatment Not Initiated/Discontinued before Treatment/Discontinued after Treatment/Withdrawal of Consent/Withdrawn/Screened/Failed Screen/Consented/Randomized/Evaluable/Completed Treatment for [country]

41

Disposition Count -Sites

Intent gives count of subject disposition for site

Count of subjects Screened/Enrolled/Follow up agreed/Follow up not agreed/Treatment Initiated/Treatment not initiated/Discontinued before Treatment/Discontinued after Treatment/Withdrawal of Consent/Withdrawn/Screened/Failed Screen/Consented/Randomized/Evaluable/Completed Treatment for Site [ID]

42

Top N Studies

Intent gives List of top N Studies based on enrollment filter criteria

List of Top 5 studies completed 100% enrollment

43

Top N Countries

Intent gives List of top N Countries based on enrollment filter criteria

Top 5 countries enrolling for study [ID/name]

44

Top N Sites

Intent gives List of top N sites based on enrollment filter criteria

Top 5 sites enrolling for study [ID/name] in [country]

45

Bottom N Studies

Intent gives List of bottom N studies based on enrollment filter criteria

List of bottom 5 studies enrolling for oncology

46

Bottom N Countries

Intent gives List of bottom N Countries based on enrollment filter criteria

Bottom 5 countries enrolling for study [ID/name]

47

Bottom N Sites

Intent gives List of bottom N Sites based on enrollment filter criteria

Bottom 5 sites enrolling for study [ID/name] in [country]

48

When – Enrollment/Enrollment Rate

Intent gives When did a <Site/Country> for <TA,Indication,Compound,Study ID> achieve the targeted Enrollment Rate or planned enrollment

When did study [ID/name] enroll X subjects

49

When -Screen Failure/ Screen Failure Rate

Intent gives When did a <Site/Country> for <TA,Indication,Compound,Study ID> face screen failure rate of x patients or x number of screen failures

When did [country] for study [ID/name] face screen failure rate of x% patients OR when did [country] for study [ID/name] have more than [x] of screen failures

50

Which Countries

Intent gives Which country participating in <TA, Indication, PPD, Compound> studies/<Study ID> has more than 50% screen failures

Which country for oncology study [ID/name] have more than x% screen failure

51

Which Studies

Intent gives Which <TA, Indication, PPD, Compound> studies in <Country> has more than 50% screen failures

Which studies for oncology have more than x% screen failure

52

Which Sites

Intent gives Which Sites for <TA, Indication, PPD, Compound> studies/StudyID in <Country> has more than < Subject disposition>

Which Sites for oncology for study [ID/name] in [country] has more than x% screen failures

53

Withdrawal Rate

Intent gives Withdrawal Rate for Study, Region, Country, and Site

Withdrawal rate/count of study [ID/name] OR Withdrawal rate/count of site [ID] OR Withdrawal rate/count of [country] OR Withdrawal rate/count of [region]

54

Enrollment Rate

Intent gives Enrollment Rate for Study, Region, Country, and Site

Enrollment rate of study [ID/name] OR Randomization rate of study [ID/name] OR Enrollment rate of site [ID] OR Enrollment rate of [country] OR Enrollment rate of [region]

55

Screen Failure Rate

Intent gives Screen Failure Rate for Study, Region, Country, and Site

Screen Failure rate/count of study [ID/name] OR Screen Failure rate/count of site [ID] OR Screen Failure rate/count of [country] OR Screen Failure rate/count of [region]

56

Randomization Failure Rate

Intent gives Randomization Failure Rate for Study, Region, Country, and Site

Randomization failure rate of study [ID/name] OR Randomization failure rate of site [ID] OR Randomization failure rate of [country] OR Randomization failure rate of [region]

57

Subject Disposition Counts

Intent gives Subject Disposition Counts < disposition event >for Study, Region, Country, and Site

 Intent also gives count of subjects for a combination of two disposition events.

Count of [Screened/ Screened failed/ Randomized/ Withdrawn> under [disposition name] for Study [ID/name]/[Region]/[country]/site [ID] OR withdrawn and randomization count for study[ID/name]/ site[ID/name] OR withdrawn or randomization count for study[ID/name]/site[ID/name]

58

Site Activation Rate

Intent gives Site Activation Rate for Study, Region, Country, and Site

Site Activation Rate in [country] OR Site Activation Rate for study [ID/name] OR List of studies with site activation rate greater than x%

59

Site Activation Cycle Time

Intent gives Site Activation Cycle Time for Study, Region, Country, and Site

Site Activation time for study [ID/name]/[Region]/[Country]

60

Site Activation Count

Intent gives Site Activation Count for Study, Region, Country, and Site
 Intent also gives the Planned & Actual Site count by combining two intents with AND. 

Number of active sites for study [ID/name]/all studies OR list of active sites for study [ID/name] OR count of planned and actual sites for study [ID/Name]/year/month
Note: Listing may not be available for planned sites, only count will be seen.

61

Planned Site Count

Intent gives Planned Site Count for Study

Count/list of planned sites in [country]

62

Active Site Count

Intent gives Active Site Count for Study

Count/list of active sites in [country] OR First/Last site activated for [portfolio]/ [study]/[region]/ [country]

63

Count/List

Intent gives Count/List- Sites <TA, Indication, Compound, Provider, CRA, CRO,PI>

Count/Number activated sites for study [ID/name] OR Count/Number open sites for study [ID/name] /[country]/[region] OR Count/Number closed sites for study [ID/name]/[country]/ [region] OR Count/Number sites from a [region]/[country] OR Count/Number of sites managed by [CRA name]

64

Count/List

Intent gives Count/List- Countries <TA, Indication, Compound, Provider, CRA, CRO >

Count of countries participating in Study [ID/name] OR Count of countries participating in [TA] OR Count of countries participating with [Phase] studies

65

Count/List

Intent gives Count/List- Study <TA, Indication, Compound, Provider, CRA, CRO >

Count/Number of studies in portfolio OR Count/Number of studies for a [TA] OR Count/Number of studies in a [phase] OR Count/Number of studies in a [program] OR Count/Number of milestones achieved for study [ID/name] OR Count/Number of milestones not achieved for study OR Count/Number of study from a [region]/[country]

66

Status

status of studies – study id, study name/ status of sites/ status of milestones

What is the status of study [ID/name] OR What is the status of [milestone name] for study [ID/name]

67

Query Closed Rate

Intent gives the rate at which queries are being closed for study/region/country/site

Closed query rate for study[ID/Name]/site[ID]/country[name]/region[name]

68

Query Answer Rate

Intent gives the rate at which queries are being answered for study/region/country/site

Query answer rate for study[ID/Name]/site[ID]/country[name]/region[name]

69

Query Rate

Intent gives rate at which queries are coming in for study/country/site/region

Query rate for study[ID/Name]/site[ID]/country[name]/region[name]

70

AE/SAE Count

Intent gives count of adverse events for study/subject/country/site/region that match specific study criteria selected in the filters

Count of Adverse Events for study[ID/Name]/Region[name], site[ID/name], subject[ID]/country[ID/name]

71

AE/SAE Rate

Intent gives rate of adverse events occurring for study/site/region/country that match the search criteria specified through the filters

Tell me AE rate for study[ID/Name]/ site[ID]/ country[ID/Name], Region[ID]

72

AE/SAE Relatedness

Intent gives list & count of adverse events/serious adverse events for study/site/country/region that match the search criteria specified in the filters

Adverse events/serious adverse events related/non related to study[ID/name]/site[ID]/country[name]/region[ID] OR adverse events where relatedness is unknown OR serious adverse events not related/related to study drug OR tell me count of adverse events

73AE Count - Severity & Relatedness Intent gives count, severity & relatedness to IP for adverse events for study/site/country/subject for a time frame that match search criteria specified in the filters
Suggestive question - count of AE intent 1 and/or/but not AE intent 2 for any specific study/country/site/region/subject (Questions should not have same intent and/or level as asked by user) 
count of mild and/or moderate AE for study[ID/name]/country/site[ID/name]/subject[ID] in month year/year OR count of related and/or unrelated AE for study[ID/name]/country/site[ID/name]/subject in month year/year OR count of AEs that are severe but not/and related OR count of AEs which are serious and related and mild for study[ID/name]/site[ID/name]/country/subject[ID] in month year/year OR count of AEs which are serious or related or mild for study[ID/name]/site[ID/name]/country/subject[ID] in month year/year
74AE Count - Severity, Relatedness, Serious, and Non-Serious AEsIntent gives count of serious/non-serious/mild/severe/related/unrelated AEs for study/site/country/region in time frame that matches the search criteria as specified in the filterscount of sites with more than 5 serious AEs and more than 10 non-serious AEs for study/country/region in month/year OR studies with more than 10 related AEs and less than 10 unrelated AEs OR countries/studies/subjects/regions with mild but not related AEs OR countries/studies/regions/subjects with more than 5 serious AEs and/or less than 5 related AEs OR studies/sites/countries/regions with more than 10 moderate or less than 10 not related AEs

75

PD Count

This intent gives the count of Protocol deviations for study/site/country/region that match the search criteria specified in the filters

Intent also gives the count and listing of combining 2 PD intents using the AND/OR/BUT operators

protocol deviation count for study[ID/name]/site[ID] OR pd count for country[name] OR pd count

studies with more than 10 minor and less than 10 major PDs OR sites with more than 10 major PDs and less than 10 minor PDs OR sites which have minor PDs but no major PDs OR sites which have major PDs but no minor PDs OR count of major and/or minor PDs for study/country/site/region

76

PD Rate

Intent gives the rate at which protocol deviations occur for a study[ID/name], site[ID], Country[Name] that match the search criteria specified in the filters.

pd rate for study[ID/name] OR protocol deviation rate

77

Timeframes for Open Query

Intent gives an account of all queries that were/are open for a given time frame or from a given point in time.

number of queries opened in last 5 years/ 2.5 months for regions OR number of queries opened in the last 4.5 years for regions OR number of queries opened in last 3 weeks for study[ID/name] OR number of queries opened in last 300 weeks for studies OR number of queries opened from Sep 2016 to July 2017 for regions OR count of open queries from 20 Jan 2020/20/1/2020 to now OR number of queries opened in Jan 2019 for regions OR count of open queries on/from/after/before 27-03-2016 OR count of open queries after 19/8/2015 OR count of open query after January 20/Jan-20 (month-year)

78

Timeframes for closed Query

Intent gives an account of all queries that are closed in a given time frame or from a given point in time.

number of queries closed before year 2010 for site[ID] OR number of queries closed before

79

Timeframes for Query Answered

Intent gives an account of all queries that were answered in a given time frame or from a given point in time.

queries answered/responded/response in last 15/30 days OR queries answered/responded/response in last week/last month/2 months/N months OR queries answered/responded/response after 15 Feb 2016 OR queries closed before 19 Nov 2019

80

Timeframes for Query Cancelled

Intent gives an account of all queries that were cancelled in a given time frame or from a given point in time.

query cancelled in last X days/weeks for countries OR query cancelled in last week/month/2 months/N months/N years/current month for studies OR queries cancelled after 15 Feb 2016 OR query cancelled before 19 Nov 2019 OR number of queries cancelled in/from/after/before year 2010 OR number of queries cancelled before 19/10/2015 OR queries cancelled in Feb-16 (month-year) for studies

81

Protocol Deviation Count or Rate (per site)

Intent gives the count or rate of protocol deviations for a specific site

PD rate for site [ID] OR number of PDs for site [ID]

82

Protocol Deviation Count or Rate (per subject)

Intent gives the count or rate of protocol deviations for a specific subject

number of PDs per subject for site [ID]

83

Protocol Deviations Count or Rate (per Visit)

Intent gives the count or rate of protocol deviations per visit

PD count per visit for study [name/ID]

84

Protocol Deviation Rate or count (per Form)

Intent gives the count or rate of protocol deviations per form

PD rate per form for study [name/ID]

85

Protocol Deviation count/rate over a particular period of time (Time frame based)

Intent gives the Protocol Deviation count/rate per study/region/country/site

Protocol deviation rate over last 5 years for study[name/ID] OR count of PDs for last 20 months OR number of PDs in year 2019 for study[name/ID]

86

AE/SAE count by Time

Intent gives the count of AE/SAE per study/region/country/site

AE/SAE count in last 3 months for study[name/ID]/site[ID]/region[name]/country[name]

87

AE/SAE Frequency by Relationship

AE frequency (percentage of subject) for study/ region/ country/site

frequency of AE with abdominal pain for study[name/ID] OR Frequency of severe adverse events for study [name/ID] OR Frequency of serious adverse events related to [drug] and moderate severity for study [name/ID]

88

AE/SAE frequency by Severity (Mild, Moderate, Severe)

Adverse Events Frequency (percentage of subject) for study/region/country/site

frequency of moderate/mild/severe AE for site [ID] OR frequency of moderate/mild/severe AE for study [name/ID]

89

AE/SAE Frequency by AE Term

Adverse Event frequency (percentage of subject) for study/region/country/site

frequency of AE with abdominal pain/ hip fracture for study[name/ID]

90
 

AE/SAE count (pie/donut chart)
 

Intent gives the AE/SAE count for site/country/region
 

plot distribution of adverse events for study[ID/name]/country/region/site[ID/name] OR plot the list of serious adverse events related to the study drug for study[ID/name]/site[ID/name]/region/country OR plot the % of serious AEs related to the drugs for study[ID/name]/site[ID/name]/region/country.
Note: For a specific combination queried upon, the other segments of the pie/donut chart will be greyed out.
 

91
 

AE Seriousness Trend (high chart)
 

Intent gives the AE serious/non-serious trend for site/country/region

trend/baseline deviation of seriousness of AE for site[ID/name]/country/region OR show the trend/baseline deviation of seriousness of AE for site[ID/Name]/country/region for study[ID/Name] OR show the trend/baseline deviation of seriousness of AE for site[ID/name] for last N months/ N year for site[ID/name]/country/region/study[ID/name] OR trend/baseline deviation of seriousness of AE in year YYYY/ for last year/ last N years for site/country/region/study[ID/name] OR trend/baseline deviation of seriousness of AE from MMM-YYYY to MMM-YYYY for site[ID/name]/country/region/study[ID/name]

92
 

AE Relatedness Trend (high chart)    
 

Intent gives the AE related/non-related trend for site/country/region    
 

trend/baseline deviation of relatedness of AE with drug for site[ID/name]/country/region/study[ID/name] OR trend/baseline deviation of relatedness of AE with drug for site[ID/name]/country/region for study[ID/name] OR trend/baseline deviation of relatedness of AE with drug in year YYYY OR trend/baseline deviation of relatedness of AE with drug for site[ID/name]/country/region for last 6 months/ 1 year / in year YYYY OR trend/baseline deviation of relatedness of AE with drug for last year/last N years OR trend/baseline deviation of relatedness of AE with drug from MMM-YYYY to MMM-YYYY

93
 

AE Seriousness & Relatedness Trend (high chart)    
 

Intent gives the AE related/non-related & serious/non-serious for site/country/region    
 

trend/baseline deviation of serious-related AEs for site[ID/name]/country/region/study[ID/name] OR trend/baseline deviation of serious-related AEs for site[ID/name]/country for study[ID/name] OR trend/baseline deviation of serious-related AEs for site[ID/name] for last N months/ N year OR trend/baseline deviation of serious-related AEs for last year/last N years for site[ID/name], country, study[ID/name] OR trend/baseline deviation of serious-related AEs from MMM-YYYY to MMM-YYYY for site[ID/name]/country/study[ID/name] OR trend/baseline deviation for AEs for study[ID/name]/country/region/site[ID/name]

94

Subject Details    
 

Intent gives count/list of subjects for study/country/site/region    
 

count/list of subjects for study[ID/name]/country/region/site[ID/name]

95

AE Term by Subject    
 

Intent gives count/list of subjects with AE Term in site/region/country/study    
 

Count/list of subjects with AE Term for study[ID/name]/country/region/site[ID/name]

96

AE Severity by Subject    
 

Intent gives count/list of subjects with Mild/Moderate/Severe severity in site/region/country/study    
 

count/list of subjects having mild/moderate/severe severity for site[ID/name]/country/region/study[ID/name] OR count/list of subjects with grade 1/2/3/4 severity for study[ID/name]/region/country/site[ID/name]

97

AE Seriousness by Subject    
 

Intent gives count/list of subjects with Serious/Non-serious adverse events    
 

count/list of subjects with serious/non-serious adverse events for study[ID/name]/country/site[ID/name]/region

98

AE Relatedness by Subject    
 

Intent gives count/list of subjects with Related/Non-related adverse events    
 

count/list of subjects with AE related/non-related/definitely related/probably related to drugs for study[ID/name]/site[ID/name]/country/region

99

CM Indication by Subject    
 

Intent gives the count/list of subjects with CM Indication for study/site/country/region    
 

list/count of subjects for indication XYZ for study[ID/name]/country/site[ID/name]/region

100

Standardized Medication Name by Subject    
 

Intent gives the count/list of subjects with Standardized Medication Name for study/country/region/site    
 

count/list of subjects for medication XYZ (standardized medication name) for study[ID/name]/site[ID/name]/country/region

101

Route of Administration by Subject    
 

Intent gives count/list of subjects by route of administration for study/country/region/site    
 

count/list of subjects related to route XYZ for study[ID/name]/site[ID/name]/country/region

102

Ongoing CM by subject    
 

Intent gives count/list of subjects with ongoing medication for study/country/region/site    
 

count/list of subjects for ongoing CM for study[ID/name]/country/region/site[ID/name] OR count/list of subjects for ongoing CMs for indication XYZ for study[ID/name]/site[ID/name]/country/region OR count/list of subjects for ongoing CMs with standardized medication name XYZ for study[ID/name]/site[ID/name]/region/country OR count/list of subjects with ongoing CMs with route of administration XYZ for study[ID/name]/country/region/site[ID/name]

103

Completed CM (Medication Status) by Subject    
 

Intent gives count/list of subjects with completed CM for study/country/site/region    
 

count/list of subjects with completed CM for study[ID/name]/site[ID/name]/country/region OR count/list of subjects with completed CM for indication XYZ for study[ID/name]/country/region/site[ID/name] OR count/list of subjects with completed CM with standardized medication name XYZ for country/site[ID/name]/region/study[ID/name] OR count/list of subjects for completed CM with route of administration XYZ for study[ID/name]/country/site[ID/name]/region

104

Lab Results by Subject    
 

Intent gives count/list of subjects associated with lab result for study/country/region/site    
 

count/list of subjects with cholesterol for study[ID/name]/country/region/site[ID/name] OR count/list of subjects with CHOL for study[ID/name]/country/site[ID/name]/region

105

Lab Results WRT Reference Range by Subject    
 

Intent gives count/list of subjects with lab results with respect to reference range for study/country/region/site    
 

count of subjects with test results within range for study[ID/name]/country/region/site[ID/name] OR count of subjects with test results out of range for study[ID/name]/region/country/site[ID/name]

106

Test Category/Test Subcategory by Subject    
 

Intent gives count/list of subjects for test category/test sub category for study/country/region/site    
 

count/list of subjects for Hematology (test category) for study[ID/name]/country/site[ID/name]/region OR count/list of subjects for Leukemia (Test Subcategory) for study[ID/name]/country/site[ID/name]/region

107

Visit Type & Test Type by Subject    
 

Intent gives count/list of subjects by visit type & test type for study/country/site/region    
 

count/list of subjects for visit2 for cholesterol/CHOL for study[ID/name]/country/region/site[ID/name]

108

Concomitant Medication by Indication

Concomitant medication for study/region/country/site

count of CMs for study[name/ID] OR list of CMs for site[ID] OR list of completed CMs for site[ID] with oral route of administration OR list of CMs for North America

109

Concomitant Medication by Indication

Concomitant Medication for study/region/country/site

conmeds for site[ID] and indication hypertension

110

Concomitant Medication by Standardized Medication Name

Concomitant Medication for study/region/country/site

standard medication name for hypertension OR standard medication name for FOSAVANCE

111

Concomitant Medication By Route of Medication

Concomitant Medication for study/region/country/site

list of CMs given ORAL/INTRAVENOUS/INTRAMUSCULAR

112CM count - Indication & route of administrationIntent gives count of CMs for indication and/or route of administration for study/country/site/region/subjects in time based queries

Suggestive questions - count of CM for intent 1 and/or/but not intent 2 for study/site/country/region/subject
count of CM for headache and/or route of administration oral for study[ID/name]/country/site[ID]/subject[ID] for year/month OR count of CM for stroke and/or/but not route of administration intravenous for study[ID/name]/site[ID]/country/region/subject[ID] for year/month Dec OR 

113

Site Issues

Intent gives count of issues open/resolved/closed for study/region/country/site
Intent gives percentage of issues resolved for study/region/country/site
Intent gives the average resolution time for study/region/country/site

Intent also gives response as count and listing by combining multiple entities using AND/OR/BUT operators

number of issues opened/resolved for more than/less than X days OR percentage of issues resolved for study[ID]/country/site[ID] OR site issue count all/open/resolved/closed for site[ID]/region OR average resolution time for study[ID]/country/site[ID] OR number of issues open since X days OR tell me open or closed site issues for study/country/region/site in year/month OR tell me open and not responded site issues for study/country/site in year 2019 OR tell me resolved but not closed site issues for study/country/site in year YYYY OR tell me resolved or closed site issues for study/site/country in year YYYY OR tell me resolved but not closed site issues for study/country/site/region in month/year.

114

Lab Results

Intent gives lab results based on test name/short name/ test category/test sub category/ reference range/visit type for study/cohort/country/region/site/subject.

list all lab results out of range for study[ID]/subject[ID] OR out of range ECG lab results for study[ID]/subject[ID] OR lab results for visit X for subject[ID] OR lab results for heart rate/lab test for site[ID]

115Multiple Lab Results in single queryIntent gives the subject count based on the one or more lab results mentioned in the query combined with AND/OR/BUT NOT operators for study/country/sitesubjects with Albumen and Bicarbonate which are out of range OR subjects with Albumen or Bicarbonate which are out of range for study/country/site in year/month/month year OR subjects with ALT higher than and/but AST in the standard reference range for study/country/site OR subjects with ALT higher than and/but not lower than standard range for study/country

116

Subject Disposition Time Frames

Intent gives responses to time based queries for all Disposition events.

list of subjects enrolled in year 2019 for study[ID]/site[ID]/country[ID]/region OR subjects terminated for site[ID]/study[ID]/country/region in last month OR screen failures for site[ID]

117

Milestone Timeframes

Intent gives responses to time based queries for milestones

count of sites with first subject enrolled/milestone name in year 2018 OR sites of CRA [name] with enrollment closed in month X year X OR studies under program[X] closed in year X month X OR studies achieved database lock in year X/ month X year X OR milestones achieved by study[ID]/site[ID] in year X month X/year X OR count of sites with first subject enrolled/milestone name in current year/month

118

Site Activation Time Frames

Intent gives responses to time based queries for site activation events.
 In addition, intent gives response to site activation time queries by combining multiple entities using AND operator

count of sites activated in country OR count of sites activated in country X in year 2019 OR activated sites for study[ID] in last month/last year OR first/last site activated for study[ID]/region/country in year 2017 OR site activation rate for study[ID] in year X/month X year X OR tell me planned and actual site activation time for study[ID/name]/site/country/region in year/month.

Note: The mean site activation time is considered for country, region and study.
For Site: Planned Site Activation Time = (Planned Site Activation Time - Site Selection Date (Actual date))
For Site: Actual Site Activation Time = (Actual Site Activation Date - Site Selection Date (Actual Date))
 

119

Subject Visits

Intent gives list of visits completed/occurred/conducted/started in year/month/week for study[ID]/site[ID]/country/region

list of visits started in last year/month/week OR list of visits started in month year OR list of completed/occurred/conducted visits in year/month/week OR list of visits completed/conducted/occurred in current/last month/year OR list of visits out of schedule/out of window for study[ID]/site[ID]/subject[ID]/country/region OR list of missed visits for study[ID]/site[ID]/subject[ID]/country/region in year 2019 OR list of visits in schedule/in window for study[ID]/site[ID]/subject[ID]/country/region in year 2018 OR list of subjects completed visit 1


Note:
** Dummy data has been used for queries written under Sample Questions.
— Outcome (results) of queries may be determined by entity values provided in the search fields under Filters
***Multiple values for a single entity, for instance, entity: study is permissible where ‘study/region/country/site’ is mentioned.
*By default, <list of milestone> gives the list of achieved milestones, unless specified in the query as ‘Planned’. The query on delayed milestones will give all milestones that have been achieved but with a delay.
— TA = Therapeutic Area
— x, X, N = integer/decimal (depending on the query)

#Points to Remember
1.DaLIA’s responses are based on actual data present in the LSAC application and the responses seen (in the DaLIA workspace) by users are based on the LSAC application access defined for each user.
2.Most queries typed in the DaLIA search box, populate filters with values. Click Reset all to clear all filter data if the next query (for DaLIA) will not consume all of the existing filter values. This will help with accurate results being generated.
3.When a key-value, that is part of the query, is identified by VA as one of the supported entities, then this entity is set in the context like: ‘Program’, ‘Sponsor’, ‘CRO’, ’Study Name’, Study ID’, ‘Region’, ‘Country, ‘Site ID’, ‘Investigator’, ‘Therapeutic Area’, ‘Indication’, ‘Phase’, ‘CRA’, and ‘Milestone Name -> study level; site level; country-level’ appears as a criterion unless it is manually changed.
4.Support entities, like more than/less than, which are applied in query formation and taken into account by DaLIA, are not maintained in context for the next query. Few examples text like ‘more’, ‘less’, ‘equal’ and %, numbers, and so on.
5.When querying on a study or on a site, it is recommended that Study ID/Name be preceded by the term ‘study’ and Site ID be preceded by the term ‘site’.
6.If the desired data has is not present in the database then DaLIA will respond as “No Data Present” . For example, for the query: <studies that have achieved all milestones>, DaLIA displays the above message since there may not be any study that has achieved all milestones so far.
If a query cannot be answered because it lacks relevant columns, DaLIA will respond as “Cannot calculate as required columns not found”. For example, for the query: <status of Australia>, DaLIA displays the above message since there are no relevant columns in the DB for the query.
7.DaLIA has not been trained on queries, forms, and on the following keywords, such as protocol deviation, SDV, missing pages, issues, pages, other issues, missing forms, forms, randomized, budget, spend, data point, data point entered.
8.Answers will be received in decimals if query contains the term ‘rate’. Answers will be received in percentage if query contains the term ‘percentage’ or the symbol ‘%’.
9.Responses for non-specific ( with no entity mentioned, i.e. studyID, siteID, site country, site region, study name) queries will be limited to 5000 records (max). Responses to entity specific queries have no limit.
10.Summary card value will be blank if the value is zero/NA (not available), for a query.
11.Queries with the word ‘count’ will give a DaLIA output containing both the count and the list.
12.Non-specific queries, for instance, pd count or pd rate will give the pd count and pd rate for all studies, respectively.
13.Count of Protocol Deviations is a cumulative count of all protocol deviations recorded with and without the Start Date.
14.Count of AEs, for a specific study/site/region/country or for a specific entity combination, is the cumulative count of all adverse events presented categorically. Thus count of AEs = count of serious & related AEs + count of serious & non-related AEs + count of non-serious & related AEs + count of non-serious & non-related AEs + incomplete data (where AE data is incomplete or relatedness to IP is unknown)

Percentage (%) AE is calculated for each category as follows:
% of Serious & Related AEs = (count of AEs that are serious & related/total count of AEs for a specific entity or entity combination) * 100
% AE for all other categories can be calculated in a similar way. 
15.All disposition events can be queried upon, either one-at-a-time or by clubbing two or more of them by using the AND & OR operators except for the dispositions events, namely, Screening and Enrollment that cannot be clubbed with other disposition events for querying. Additionally, time frames such as, a date range, month, year, are not considered when two disposition events are clubbed together for querying.
16.When querying on a subject, it is recommended that the Subject ID be preceded by the term ‘subject’.
17.Date formats accepted by DaLIA are are follows: 1) dd-mm-yyyy 2) yyyy-dd-mm
18.Subject Visit intents include both scheduled and unscheduled subject visits.
19.Time terminology:
Last N years – This timeframe is calculated from present(current) date to date (covering N years)
Previous N years – This timeframe is calculated to take the previously completed N years which may not include the current year.
20.Adverse Event Count is calculated as the number of AEs related to a specific subject irrespective of subject disposition status.
21.Questions on query status (open/closed/anwered and so on) is answered with respect to the timeframe (mentioned in the question) irrespective of the query’s current status.
22.Site activation percentage (%) in DaLIA is calculated as number of actual Active sites/Total Planned Sites
23.“Issue” values given in issue-based queries are not applied by the DaLIA Smart Search bar when querying. The user needs to specify an “issue value” from the Filters in the left pane to get the correct results.
24.“Visit” values given in visit-based queries are not applied by the DaLIA Smart Search bar when querying. The user needs to specify a “visit value” from the Filters in the left pane to get the correct results.
25.Integer values with keywords such as “visit”, “week”, “day” may give incorrect results. For instance, “tell me lab results for visit Cycle 1 Day 1 for ECG”. If possible, the user needs to specify the “visit”, “week” or “day” values from the Filters in the left pane to get the correct results.
26.DaLIA Audit Trail Report can be accessed by a user with Admin access only.
27.There are query suggestions and entity suggestions (like, site ID, study ID/name, country and so on) provided in the search box as you create your query. It is important to note that if a query is not tied to a specific entity, then DaLIA’s response is determined by the first query suggestion that appears in the search box dropdown. Click on the correct query suggestion, as circled below, to get expected results. For example, for the query: <enrollment rate>, the following query suggestions would populate as seen below, where () indicates Dashboard, () indicates Report Analytics and () indicates DaLIA Search.