Creating
SDV marks for questions
You can create SDV marks for questions, eForms, visits or subjects, but you can only create one SDV mark for each item.
An SDV mark can be raised for a question that has been frozen but not for a question that has been locked. More information...
Creating
SDV marks for questions
To create an SDV mark for a question, you
need the 'Create SDV at question level' permission
There are two ways to create an SDV mark for a question. Note that if an SDV mark already exists for the question, you will not be given the option of creating another one.
Right click the question status icon and select SDV Mark > Add from the popup menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters.
Click
a circle to set the status
of the new SDV mark to Planned 
, Queried 
or Done 
.
Click OK. A new SDV with the specified status will be created.
Select View >
Search Panel or click the Open Search Panel icon 
to open the search panel. General help on using the search
panel
When you open the search panel, it will appear as it was when the panel was last closed.
At any
time you can clear all the search fields by clicking
the Clear Search fields icon 
at the top of the panel.
To save
a search for future use, click
the Save Search icon 
at the top
of the panel to save the current combination of search
settings. Enter a name for the new search or
click Replace Search and select a search to overwrite.
Click Save. Searches are stored separately for each
user. To open a
previously stored search, click the arrow to the right
of the Open Stored Search icon 
at the top of the panel and select a search from the
drop down list.
Select Data from the drop down list at the top.
Select your search criteria. Help on each field within the search panel
Detail |
Select the level of detail to which you want to see data. |
Study |
If you are permitted access to data from more than one study, you can choose to view data from all studies, or from a particular study only. Select your choice from the drop down list. |
Site |
If you are permitted access to data from more than one site, you can choose to view data from all sites, or from a particular site only. Select your choice from the drop down list. |
Subject |
You can choose to view data entered for a particular subject only, by entering the subject label (part or whole), or the subject ID. The subject list will open, containing only those subjects who fit your search criteria. |
Select/Clear All |
Use this toggle to either check all the status boxes or to clear all checks. Hover over a status icon to see the status label as a tooltip. |
status |
Click these check boxes to include all questions with a particular status or combination of statuses. You can select multiple check boxes. |
Comments |
You can choose to:
Select your choice from the drop down list. |
Notes |
You can choose to:
Select your choice from the drop down list. |
Frozen/Locked |
You can choose to:
Select your choice from the drop down list. |
DCR |
Select a status from the list to include questions with DCRs of that status. The statuses are raised, responded, closed, printed or received. This section is only available if your user permissions allow you access to DCR data. |
SDV |
Select a status from the list to include questions with SDV marks of that status. The statuses are planned, queried, done or cancelled. This section is only available if your user permissions allow you access to SDV data. |
Visit |
You can include data from all visits, or from a particular visit only. Select your choice from the drop down list. |
eForm |
You can include data from all eForms, or from a particular eForm only. Select your choice from the drop down list. This list will only contain eForms available in the selected visit. |
Question |
You can include data from a particular question only. Select your choice from the drop down list. This list will only contain questions available in the selected visit/eForm combination. |
User |
You can include data entered by all users, or by a particular user only. To specify a particular user, select the name from the drop down list. |
Search |
You can search for data before or after a certain date, during a certain period or with no date restrictions. Select your choice from the drop down list. |
From |
Enter the date from which you want to search by clicking the arrow and selecting the date form the popup calendar. |
To |
Enter the date to which you want to search by clicking the arrow and selecting the date form the popup calendar. |
Type |
You can choose to view thesaurus questions associated with all MedDRA dictionaries, or from a particular dictionary only. Select your choice from the drop down list. |
Statuses |
You can choose to view thesaurus questions with a specific coding status. Select your choice from the drop down list. |
Click
the Execute search button
to
display the data in the Data Browser in the main window. What to do if you are told your
search exceeds the maximum number of records
You will be alerted if your search results exceed the maximum number of records allowed in a browser report. If this happens the DCR browser will not open until you change your search criteria to reduce the number of DCRs in the results.
Once the report is open in the browser, the number of records displayed is shown at the bottom of the browser.
To change the maximum records limit, go to Tools > Options.../Administrator Options...
Right click the question and select New Question SDV Mark from the popup menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters..
Click
a circle to set the status
of the new SDV mark to Planned, Queried or Done.
Click OK. A new SDV with the specified status will be created.
Creating
SDV marks for eForms To create an SDV mark for an eForm, you
need the 'Create SDV at eForm level' permission
There are two ways to create an SDV mark for an eForm. Note that if an SDV mark already exists for the eForm, you will not be able to create another one.
Right click on the eForm for which you wish to create an SDV and select Create/Edit eForm SDV... from the drop down menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters.
Click
a circle to set the status
of the new SDV mark to Planned, Queried or Done.
Click OK. A new SDV with the specified status will be created.
Select View >
Search Panel or click the Open Search Panel icon
to open the search panel. General help on using the search
panel
When you open the search panel, it will appear as it was when the panel was last closed.
At any
time you can clear all the search fields by clicking
the Clear Search fields icon
at the top of the panel.
To save
a search for future use, click
the Save Search icon at the top
of the panel to save the current combination of search
settings. Enter a name for the new search or
click Replace Search and select a search to overwrite.
Click Save. Searches are stored separately for each
user. To open a
previously stored search, click the arrow to the right
of the Open Stored Search icon
at the top of the panel and select a search from the
drop down list.
Select Data from the drop down list at the top.
Select your search criteria. Help on each field within the search panel
Detail |
Select the level of detail to which you want to see data. |
Study |
If you are permitted access to data from more than one study, you can choose to view data from all studies, or from a particular study only. Select your choice from the drop down list. |
Site |
If you are permitted access to data from more than one site, you can choose to view data from all sites, or from a particular site only. Select your choice from the drop down list. |
Subject |
You can choose to view data entered for a particular subject only, by entering the subject label (part or whole), or the subject ID. The subject list will open, containing only those subjects who fit your search criteria. |
Select/Clear All |
Use this toggle to either check all the status boxes or to clear all checks. Hover over a status icon to see the status label as a tooltip. |
status |
Click these check boxes to include all questions with a particular status or combination of statuses. You can select multiple check boxes. |
Comments |
You can choose to:
Select your choice from the drop down list. |
Notes |
You can choose to:
Select your choice from the drop down list. |
Frozen/Locked |
You can choose to:
Select your choice from the drop down list. |
DCR |
Select a status from the list to include questions with DCRs of that status. The statuses are raised, responded, closed, printed or received. This section is only available if your user permissions allow you access to DCR data. |
SDV |
Select a status from the list to include questions with SDV marks of that status. The statuses are planned, queried, done or cancelled. This section is only available if your user permissions allow you access to SDV data. |
Visit |
You can include data from all visits, or from a particular visit only. Select your choice from the drop down list. |
eForm |
You can include data from all eForms, or from a particular eForm only. Select your choice from the drop down list. This list will only contain eForms available in the selected visit. |
Question |
You can include data from a particular question only. Select your choice from the drop down list. This list will only contain questions available in the selected visit/eForm combination. |
User |
You can include data entered by all users, or by a particular user only. To specify a particular user, select the name from the drop down list. |
Search |
You can search for data before or after a certain date, during a certain period or with no date restrictions. Select your choice from the drop down list. |
From |
Enter the date from which you want to search by clicking the arrow and selecting the date form the popup calendar. |
To |
Enter the date to which you want to search by clicking the arrow and selecting the date form the popup calendar. |
Type |
You can choose to view thesaurus questions associated with all MedDRA dictionaries, or from a particular dictionary only. Select your choice from the drop down list. |
Statuses |
You can choose to view thesaurus questions with a specific coding status. Select your choice from the drop down list. |
Click
the Execute search buttonto
display the data in the Data Browser in the main window. What to do if you are told your
search exceeds the maximum number of records
You will be alerted if your search results exceed the maximum number of records allowed in a browser report. If this happens the DCR browser will not open until you change your search criteria to reduce the number of DCRs in the results.
Once the report is open in the browser, the number of records displayed is shown at the bottom of the browser.
To change the maximum records limit, go to Tools > Options.../Administrator Options...
Right click the eForm and select New eForm SDV Mark from the popup menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters.
Click
a circle to set the status
of the new SDV mark to Planned, Queried or Done.
Click OK. A new SDV with the specified status will be created.
Creating
SDV marks for visits To create an SDV mark for a visit, you need
the 'Create SDV at visit level' permission
There are two ways to create an SDV mark for a visit. Note that if an SDV mark already exists for the visit, you will not be able to create another one.
Right click on the visit for which you wish to create an SDV and select Create/Edit Visit SDV... from the drop down menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters.
Click
a circle to set the status
of the new SDV mark to Planned, Queried or Done.
Click OK. A new SDV with the specified status will be created.
Select View >
Search Panel or click the Open Search Panel icon
to open the search panel. General help on using the search
panel
When you open the search panel, it will appear as it was when the panel was last closed.
At any
time you can clear all the search fields by clicking
the Clear Search fields icon
at the top of the panel.
To save
a search for future use, click
the Save Search icon at the top
of the panel to save the current combination of search
settings. Enter a name for the new search or
click Replace Search and select a search to overwrite.
Click Save. Searches are stored separately for each
user. To open a
previously stored search, click the arrow to the right
of the Open Stored Search icon
at the top of the panel and select a search from the
drop down list.
Select Data from the drop down list at the top.
Select your search criteria. Help on each field within the search panel
Detail |
Select the level of detail to which you want to see data. |
Study |
If you are permitted access to data from more than one study, you can choose to view data from all studies, or from a particular study only. Select your choice from the drop down list. |
Site |
If you are permitted access to data from more than one site, you can choose to view data from all sites, or from a particular site only. Select your choice from the drop down list. |
Subject |
You can choose to view data entered for a particular subject only, by entering the subject label (part or whole), or the subject ID. The subject list will open, containing only those subjects who fit your search criteria. |
Select/Clear All |
Use this toggle to either check all the status boxes or to clear all checks. Hover over a status icon to see the status label as a tooltip. |
status |
Click these check boxes to include all questions with a particular status or combination of statuses. You can select multiple check boxes. |
Comments |
You can choose to:
Select your choice from the drop down list. |
Notes |
You can choose to:
Select your choice from the drop down list. |
Frozen/Locked |
You can choose to:
Select your choice from the drop down list. |
DCR |
Select a status from the list to include questions with DCRs of that status. The statuses are raised, responded, closed, printed or received. This section is only available if your user permissions allow you access to DCR data. |
SDV |
Select a status from the list to include questions with SDV marks of that status. The statuses are planned, queried, done or cancelled. This section is only available if your user permissions allow you access to SDV data. |
Visit |
You can include data from all visits, or from a particular visit only. Select your choice from the drop down list. |
eForm |
You can include data from all eForms, or from a particular eForm only. Select your choice from the drop down list. This list will only contain eForms available in the selected visit. |
Question |
You can include data from a particular question only. Select your choice from the drop down list. This list will only contain questions available in the selected visit/eForm combination. |
User |
You can include data entered by all users, or by a particular user only. To specify a particular user, select the name from the drop down list. |
Search |
You can search for data before or after a certain date, during a certain period or with no date restrictions. Select your choice from the drop down list. |
From |
Enter the date from which you want to search by clicking the arrow and selecting the date form the popup calendar. |
To |
Enter the date to which you want to search by clicking the arrow and selecting the date form the popup calendar. |
Type |
You can choose to view thesaurus questions associated with all MedDRA dictionaries, or from a particular dictionary only. Select your choice from the drop down list. |
Statuses |
You can choose to view thesaurus questions with a specific coding status. Select your choice from the drop down list. |
Click
the Execute search buttonto
display the data in the Data Browser in the main window. What to do if you are told your
search exceeds the maximum number of records
You will be alerted if your search results exceed the maximum number of records allowed in a browser report. If this happens the DCR browser will not open until you change your search criteria to reduce the number of DCRs in the results.
Once the report is open in the browser, the number of records displayed is shown at the bottom of the browser.
To change the maximum records limit, go to Tools > Options.../Administrator Options...
Right click the visit and select New Visit SDV Mark from the popup menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters.
Click
a circle to set the status
of the new SDV mark to Planned, Queried or Done.
Click OK. A new SDV with the specified status will be created.
Creating
SDV marks for subjects To create an SDV mark for a subject, you
need the 'Create SDV at subject level' permission
There are two ways to create an SDV mark for a subject. Note that if an SDV mark already exists for the subject, you will not be able to create another one.
Right click on the subject label and select Create/Edit Subject SDV... from the drop down menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters.
Click
a circle to set the status
of the new SDV mark to Planned, Queried or Done.
Click OK. A new SDV with the specified status will be created.
Select View >
Search Panel or click the Open Search Panel icon
to open the search panel. General help on using the search
panel
When you open the search panel, it will appear as it was when the panel was last closed.
At any
time you can clear all the search fields by clicking
the Clear Search fields icon
at the top of the panel.
To save
a search for future use, click
the Save Search icon at the top
of the panel to save the current combination of search
settings. Enter a name for the new search or
click Replace Search and select a search to overwrite.
Click Save. Searches are stored separately for each
user. To open a
previously stored search, click the arrow to the right
of the Open Stored Search icon
at the top of the panel and select a search from the
drop down list.
Select Data from the drop down list at the top.
Select your search criteria. Help on each field within the search panel
Detail |
Select the level of detail to which you want to see data. |
Study |
If you are permitted access to data from more than one study, you can choose to view data from all studies, or from a particular study only. Select your choice from the drop down list. |
Site |
If you are permitted access to data from more than one site, you can choose to view data from all sites, or from a particular site only. Select your choice from the drop down list. |
Subject |
You can choose to view data entered for a particular subject only, by entering the subject label (part or whole), or the subject ID. The subject list will open, containing only those subjects who fit your search criteria. |
Select/Clear All |
Use this toggle to either check all the status boxes or to clear all checks. Hover over a status icon to see the status label as a tooltip. |
status |
Click these check boxes to include all questions with a particular status or combination of statuses. You can select multiple check boxes. |
Comments |
You can choose to:
Select your choice from the drop down list. |
Notes |
You can choose to:
Select your choice from the drop down list. |
Frozen/Locked |
You can choose to:
Select your choice from the drop down list. |
DCR |
Select a status from the list to include questions with DCRs of that status. The statuses are raised, responded, closed, printed or received. This section is only available if your user permissions allow you access to DCR data. |
SDV |
Select a status from the list to include questions with SDV marks of that status. The statuses are planned, queried, done or cancelled. This section is only available if your user permissions allow you access to SDV data. |
Visit |
You can include data from all visits, or from a particular visit only. Select your choice from the drop down list. |
eForm |
You can include data from all eForms, or from a particular eForm only. Select your choice from the drop down list. This list will only contain eForms available in the selected visit. |
Question |
You can include data from a particular question only. Select your choice from the drop down list. This list will only contain questions available in the selected visit/eForm combination. |
User |
You can include data entered by all users, or by a particular user only. To specify a particular user, select the name from the drop down list. |
Search |
You can search for data before or after a certain date, during a certain period or with no date restrictions. Select your choice from the drop down list. |
From |
Enter the date from which you want to search by clicking the arrow and selecting the date form the popup calendar. |
To |
Enter the date to which you want to search by clicking the arrow and selecting the date form the popup calendar. |
Type |
You can choose to view thesaurus questions associated with all MedDRA dictionaries, or from a particular dictionary only. Select your choice from the drop down list. |
Statuses |
You can choose to view thesaurus questions with a specific coding status. Select your choice from the drop down list. |
Click
the Execute search buttonto
display the data in the Data Browser in the main window. What to do if you are told your
search exceeds the maximum number of records
You will be alerted if your search results exceed the maximum number of records allowed in a browser report. If this happens the DCR browser will not open until you change your search criteria to reduce the number of DCRs in the results.
Once the report is open in the browser, the number of records displayed is shown at the bottom of the browser.
To change the maximum records limit, go to Tools > Options.../Administrator Options...
Right click the subject and select New Subject SDV Mark from the popup menu. The New SDV window is displayed.
Enter your text into the text field to give details of the data verification. There is a limit of 2000 characters.
Click
a circle to set the status
of the new SDV mark to Planned, Queried or Done.
Click OK. A new SDV with the specified status will be created.