XML4Pharma's ODM Study Designer New features of version 2010-R1 and 2010-R2

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1 XML4Pharma's ODM Study Designer New features of version 2010-R1 and 2010-R2 Author: Jozef Aerts, XML4Pharma Last Version: September 7, 2010 New features of version 2010-R2 Search panel further improved The Search panel (introduced in version 2009-R2) which can at all times be opened or closed in the designer panels, has been further improved. New buttons in the design panels New buttons have been added to the design panels that come for each ODM element. These allow to move rows up and down, to copy rows, to automatically assign the OrderNumber, or to sort the rows by OrderNumber. This better allows to order the rows in a natural order. Improved local validation for non-schema rules The Validate button now also executes validation for non-schema rules, this using a Schematron. As such a deep validation takes more time than a strict schema-validation, the deep validation can be switched off / on from the Options menu. XML tree view Upon request of some of our customers, we have added the possibility for an XML tree view. ODM Study Designer 2010_R1_R2 new features 1

2 This advanced feature allows to inspect the generated XML in very user-friendly way. Deep ODM Tree View A deep view facility has been added to the software. It generates a deep view, i.e. allowing to drill down from a StudyEvent (visit) to the indivual Items and associated CodeLists, and showing a tabular presentation in HTML format of the information. This HTML also contains hyperlinks that can be followed in order to obtain even more information and to drill deeper down. This view also contains a number of search facilities. ODM Study Designer 2010_R1_R2 new features 2

3 Performance improvements Successful efforts have been taken to further improve the memory usage of the software. The new version is now also able to load (very) large libraries such as the public Lilly ODM library. New features of version 2010-R1 Star and Web view of the study design New menu items have been added that enable to generate star and web views of the study design. An example of such a star view is given below. It allows to obtain a quick visual overview of the study structure: which forms are used in which visits, which panels (ItemGroups) in which forms, etc.. The web view differs from the star view that it also shows how items (Forms, ItemGroups, Items) are being reused in the design. Full HTML view of the study design The complete study design can now be transformed into HTML with views of the CRFs. A stylesheet to do so is delivered with the software and can be further tailored to individual requirements (or taste). The HTML view cannot only be saved to file but also be transformed into a PDF document. This HTML view has been found extremely useful by our customers to discuss the study design with colleagues, investigators, etc.. ODM Study Designer 2010_R1_R2 new features 3

4 The items in the forms are annotated with SDTM and CDASH information if this information has been added to the study design. This information is already included when CDASH forms are loaded from the internal library. ODM Study Designer 2010_R1_R2 new features 4

5 Individual annotated CRFs Individual annotated CRFs can be generated (Swing format). These can then be transformed into annotated PDFs. Annotations include datatype, allowed (CodeList) values, and of course SDTM and CDASH information. Much faster navigation for insertion of new forms, itemgroups, etc. A menu has been added to directly add a new form, itemgroup, etc. to the study design. ODM Study Designer 2010_R1_R2 new features 5

6 New features of version 2009-R2 Search facilities When working with large or complex study designs, or with large libraries of e.g. CRF questions (ItemDefs), codelists etc., it is often not very easy to find a specific item. For example, when one has loaded a library with over 1000 CRF questions, and wants to add the question about the subject's birth date, one needs to find that Item first in the list of over 1000 ItemDefs, in order to be able to drag-and-drop the question on the subform (ItemGroupDef). This is where search facilities come to help. 1. Finding an item in a large table Let us take the example of a large table with ItemDefs. In version 2009-R2 an extra Search button (near the bottom) has been added. It allows to show / hide an extra panel allowing to search in the table: ODM Study Designer 2010_R1_R2 new features 6

7 When the Show Search Panel is clicked, an extra panel becomes available at the top (above the table): allowing to search in the table. One can select where (i.e. in which attributes) one want to search using any of the checkboxes (there is a checkbox for each attribute). For example, if one wants to search for the term Medication (in any of the fields), one enters the search term in the text field Search for and then clicks the button Search. The result is that the first table cell where the word medication occurs is selected, and is scrolled to: ODM Study Designer 2010_R1_R2 new features 7

8 Further occurrences can be found using the Find Next button. 2. Finding an item for drag-and-drop Let us try to add a question (ItemDef) to a subform (ItemGroupDef). If one has a large number of ItemDefs, this is not always an easy task: one might e.g. only now that the question is about non-study medication, but one does (of course) not know what the OID is. When double-clicking an ItemGroupDef Add Information icon 1, one can add additional Items using either drag-and-drop or by double-clicking the cell. Let us first at the new Search facilities for the drag-and-drop: 1 This is the icon in the first column: ODM Study Designer 2010_R1_R2 new features 8

9 One notices a new Search button below the list of all possible ItemDefs. When it is clicked, a new window is shown: Now the user knows that the question (ItemDef) is about non-study medications, but does not know what the OID is. The user may go through all the entries in the list on the right side, as each of them have a tooltip with the name of the Item (taken from the Name attribute in ItemDef), but when having several hundreds of entries or more, this takes too much time. Instead one can use the new search facilities. One can search for the term Medication either in the list of OIDs, or in the list of Item names (the latter are only visible as tooltips). When entering Medication in the Search for: field and clicking the Search button, the first entry in the list on the right for which a match is found is selected. At the same time, the fully text of the match is shown in the Search window itself: ODM Study Designer 2010_R1_R2 new features 9

10 Further matches can be found using the Search from Selected Index button. If this is the Item the user was looking for, he/she can now drag-and-drop it in the table of Items for the specific subform (ItemGroupDef), i.e.: As usual, using the Validate button (at the right near the bottom) is always a good idea to check whether all necessary information has been added. One obtains: ODM Study Designer 2010_R1_R2 new features 10

11 The Mandatory attribute is... mandatory, so we need to add a value. This is done using the dropdown list, as only the values Yes and No are allowed according to the ODM standard: The OrderNumber is not mandatory, but as it was assigned for the other items, one can also add one here. 3. Finding an item from the extended table Some users do not like to use the drag-and-drop facilities, but just to like to be able to select the item from a table with the OIDs and names (Name attribute). This can be done by a double-click in the cell for the ItemOID attribute. A new window is displayed, showing all possible Items that are currently present in the system, with OID and Name: ODM Study Designer 2010_R1_R2 new features 11

12 Also here, one notices the new Search button. When clicked, the same window shows up as in the previous case: ODM Study Designer 2010_R1_R2 new features 12

13 When entering the search term medication and clicking the Seach button, the systems find the first match in the table (in this case as well for the OID as for the Name), and jumps to the first cell for which a match is found: The cell is automatically selected. When this was the Item that was looked for, one can close the Search window, and click OK in the dialog with the table of all Items. The selected information (OID) is then automatically added to the list of Items to be used in the subform (ItemGroupDef). ODM Study Designer 2010_R1_R2 new features 13

14 These three search facilities are not only available for ItemDef or ItemGroupDef, but in principle for each panel where it is useful. The first search facility is essentially present in each panel where definitions are added or presented. For example for the ODM elements MeasurementUnitDef, CodeList, MethodDef, but also for e.g. for the RangeCheck element. The second and third search facilities are present for each case where one wants to use (reference) an item for which there is an OID exists (StudyEvent, Form, ItemGroup, Item, CodeLists, Method, MeasurementUnit), within another item. I.e. whenever the ODM Ref-Def mechanism is present. For example, in order to add a unit of measurement (MeasurementUnitRef) to a question (ItemDef), one can also use the search facility: These new search facilities make it considerably easier to work with large libraries, such as have been developed by several sponsors and organizations. ODM Study Designer 2010_R1_R2 new features 14

15 New features of version 2009-R1 Version 2009-R1 of the ODM Study Designer has a number of new features. These include: extended support for define.xml vendor extensions: loading reference-definition pairs for extension elements CDASH forms included Schedule of Visits Views cleaning up functionality 1. Extended support for define.xml At startup time, when choosing for define.xml, an additional checkbox shows up asking whether ODM elements not used by define.xml should be disabled. When checking this box, no GUI elements for ODM elements that are defined by the ODM 1.2 standard, but that are not used by define.xml (such as Protocol, StudyEventDef, FormDef, will be created. This functionality is especially useful when working on standard define.xml files which will be used for submission to the FDA only. 2. Vendor extensions, loading reference-definition pairs for extension elements ODM Study Designer 2010_R1_R2 new features 15

16 Many ODM Vendor Extensions (based on the vendor extension mechanism as of ODM XML- Schema 1.2.1) use the, similarly to the ODM itself, so-named reference-definition or Ref- Def mechanims. For example in the ODM, a form is defined using the FormDef element, whereas it is referenced by the StudyEventDef element by use of the FormRef element. Similarly, when an extension element has been defined that has an OID, it can be referenced by another element/attribute combination. For example, suppose we have defined a vendor extension element (in its own namespace) my:armdef with an attribute OID and an attribute Name. Suppose that in the StudyEventRef element, we have added an extra attribute my:armoid, referencing the ArmDef with the same OID. Now, the relation between ArmOID and ArmDef OID cannot be expressed in an XML- Schema, so we need to express it explicitely, just by providing is as a pair: my:armoid my:armdef A number of such pairs (one pair per line) can be added to a simple text file for a specific vendor extension. This file is the file that can then be loaded after the system has asked for the XML-Schema of the vendor extension. The distribution comes with a sample directory CDISC_ODM_1_3_Vendor_Extensions which contains a very simple vendor extension example, and for which the schema file is mysimple.xsd. The directory also contains a file RefDef_for_extension.txt containing the above shown line defining the ref-def relationship between ArmOID and ArmDef 2. So when starting working with this vendor extension, one will have the following sequence: 2 Remark that no prefix should be given in the case a regular ODM element is referenced, e.g. when the vendor extension attribute my:previousstudyeventoid referenced the StudyEventDef element, the line in the file is simply: my:previousstudyeventoid StudyEventDef ODM Study Designer 2010_R1_R2 new features 16

17 and ODM Study Designer 2010_R1_R2 new features 17

18 In the Study MetaData part, one now finds a new (vendor extension) element ArmDef, with two (mandatory) attributes OID and Name. Once we have defined some arms, they can be referenced. After having defined some StudyEvents, and when one now goes to the Protocol element, and clicks the + icon to add StudyEvents, one sees: When clicking in the ArmOID cell 3, the right side of the window changes, and the previous defined Arms are shown: One can now drag-and-drop one of them into the ArmOID cell. The result is e.g.: 3 Remark that the column title for this attribute is colored blue, reminding us that it is an extension attribute ODM Study Designer 2010_R1_R2 new features 18

19 P.S.: In the sample extension, the VisitSchedule and ScheduleReference allow to add timeplanning of visits, e.g. visit SE.005 should e.g. come 10 days after the previous visit, or e.g. 30 days after the first visit. 3. CDASH forms Version 2009-R1 of the software implements the CDASH forms. Using the menu CDASH -> Load CDASH forms, one can select which CDASH forms one wants to add to the study design: After having selected the desired forms, the software will ask for the default text Length for the ItemDefs that are loaded, as the CDASH standard does not define what these lengths should be: ODM Study Designer 2010_R1_R2 new features 19

20 One can now immediately use the CDASH forms (e.g. in the ecrf view), but one is advised to first look at the individually loaded ItemDefs and ItemGroupDefs, and to tailor these to the specific study, this as the published CDASH forms have a lot of defaults in them, wich may not be applicable to your study. Also, you might want to add additional fields to the loaded CDASH forms. Remark: in near future, one will be able to load different implementations (i.e. different scenarios as defined in the CDASH document) of the same CDASH form. Another CDASH functionality is that one can inspect the properties of the loaded CDASH variables, using the menu CDASH -> Show CDASH Variable Properties. For example: ODM Study Designer 2010_R1_R2 new features 20

21 This essentially gives you the information from the documentation of the CDASH 1.0 standard. ODM Study Designer 2010_R1_R2 new features 21

22 4. Schedule of Visits Views Using the menus View Schedule of Visits (table) and View Schedule of Visits (grid), the user can now inspect the schedule of vists. Using the first menu, a table of all the visits (as listed in the Protocol ) is given together with the list of Forms used in each visit. Using the menu View Schedule of Visits (grid), the user obtains a grid view of the schedule of visits. The button Switch View allows to switch between a view where the visits (StudyEvents) are on the vertical axis, and a view where the visits are on the horizontal axis. ODM Study Designer 2010_R1_R2 new features 22

23 In the table, it is shown whether the used form is optional (O) or mandatory (M), and whether it is repeating ((R)). 5. Cleaning up facilities Companies will typically use libraries of CodeLists, ItemDefs, ItemGroupDefs, etc.., which can be loaded using the Load from Library buttons. This may mean that one has e.g. much more ItemDefs loaded than are actually used (i.e. referenced from ItemGroupDef elements). All these loaded ItemDefs will also appear in the ODM file when one saves the study design using File -> Save Study. In order to have a smaller ODM file, one can use the Edit -> Clean menu. The following window will appear: Using this wizard, one can first view e.g. which StudyEvents are not referenced (by the Protocol element), and then remove them from the study design if desired. Similarly for CodeLists and ItemDefs, one can inspect which ones are not used, and remove them if desired. ODM Study Designer 2010_R1_R2 new features 23

24 Remark that cleaning up is potentially dangerous when you are not ready yet with your study design. So it is always wise to first make a save of everything, before cleaning up the study design. 6. Other small improvements and new features validation is now possible when loading an existing ODM file with a study design. When the user loads an existing ODM file with study design information, the user is asked whether validation should be performed immediately. Faster navigation using the Add menu. A new menu Add has been added to allow faster navigation. It allows to quickly add a new StudyEvent, Form,..., etc. without needing to select the corresponding tab. When selected, the system immediately selects the corresponding tab, adds a new row to the table when necessary, and positions the cursor in the first cell of the row. ODM Study Designer 2010_R1_R2 new features 24

25 New features of version 2008-R1 Version 2008-R1 of the ODM Study Designer has a number of new features. These include: Faster menu navigation through menu shortcuts Full support for ODM 1.3 and all vendor extensions based on ODM 1.3 Improved validation against the ODM standard Create, view and test prototype Annotated CRFs In version 1.1, it is possible to create and test prototype annotated CRFs. In order to do so, use the menu View Annotated CRFs (Ctrl-E). You will be presented a list of forms you have created sofar, and a list of all the languages for which translations of items have been given. Choose the form of your choice, and the language in wich the selected form should appear. Then click OK. An prototype annotated version of the ecrf is shown in a separate window. For example: ODM Study Designer 2010_R1_R2 new features 25

26 Now you can try out the ecrf. It allows you to check whether you have set the correct data types, whether your codelists are complete, but also whether you provided all necessary translations for the questions, group labels, and codelist items. For example, if you did not provide the french translation for the Item F (Female) in the codelist, and you try out the french version of the form, you will see that when you try the use the combobox for Gender, one of the Items is given as ERROR: NO TRANSLATION given yet. Furthermore, you can test the data types. If for example, you have defined Site Number as an integer, than it should only be possible to enter an integer in the corresponding text field. For a good number of data types (like dates, times, datetimes, durations), special widgets are provided. The annotations become visible when one holds the mouse over a label or widget. When one holds the mouse over a widget, the data type is shown, and whether a codelist is involved. When holding the mouse over a group label, the associated SDTM Domain is made visible (if one has been defined). Similarly, when one holds the mouse over a question label, the SDTM Variable Name is shown, if one has been defined in the study design (ODM SDSVarName attribute). ODM Study Designer 2010_R1_R2 new features 26

27 P.S. Conditional occurrence of questions (ODM 1.3) has not been implemented yet in the ecrf prototype viewer. ODM Study Designer 2010_R1_R2 new features 27