Viedoc Repeating Item Groups Webinar Q&A
Webinar Recording
This video is a recording of the Repeating Item Groups webinar, part of the "Working Smarter series":
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Note! After discussion with Antti 18/3 add ROW link here..not China link.
Repeating Item Groups - Q&A
Below are questions and answers from the Repeating Item Groups Webinar.
Form design
Q: What are typical use cases for repeating item groups?
A: Common use cases include lab analytes, physical examination, vital signs collected multiple times, and capturing multiple episodes within a single form, such as adverse events. They are useful both when the number of entries may vary between subjects and when the number of entries is fixed.
Q: When should you choose a fixed structure versus a dynamic structure?
A: Use a fixed structure when the number of expected entries is predefined and consistent. Use a dynamic structure when the number of entries may vary and flexibility is required at site level.
Q: Do you have to define a maximum number of repeats, or is it possible to have item groups repeat ad libitum?
A: A maximum number of occurrences must be defined. The highest number that can be configured is 50.
Q: Are optional item groups possible, like a minimum repetition number of zero?
A: The minimum number of occurrences that can be configured is 1. Items within a repeating item group can be optional, but this means they will be optional in all occurrences. If there is a possibility that no occurrences will be entered, we recommend using a leading Yes/No question to trigger the repeating item group, for example: Was any [data from the repeating item group] collected? Yes/No.
Q: Can you define two separate unique repeating groups in one form? And if so, will each of them have a separate dataset in the export?
A: Yes, it is possible to have multiple repeating item groups within one form. If the new default export structure is used (“repeating item group as a separate form”), each repeating item group will be exported as its own separate dataset.
Q: Can we use repeating item groups in forms having multiple timepoints like PK, PD?
A: Yes, this is possible. This can be designed either as one form per timepoint and one form per activity, as a repeating form, or as one form with a repeating item group to capture multiple timepoints within a single form.
Q: Vital sign can be collected hourly. Instead of a number can we display e.g. “1-hour vital signs” for the occurrences.
A: No, the number displayed in Viedoc Clinic is a system setting and will always be shown as a sequence number to the user. This also means that in some scenarios it may not match the ItemGroupRepeatKey, since certain occurrences could be hidden for a user. However, you can populate desired text in an item within the group, to clarify to the user that it is in fact the “1-hour vital signs”.
Q: Will the new variable names always have the ending REP, e.g. LBTESTREP?
A: No, this was for demonstration purposes only. The designer can configure the OID of the items and item group.
Q: If we set 17 occurrences, will we always see 17? or 17 is the max we can see, but we can see for example 5, according to data entry?
A: The minimum number of occurrences is what the user will see when opening the form (assuming there are no visibility conditions configured). Users will not be able to remove occurrences below the minimum number.
The maximum number of repeats is the maximum number of occurrences that can be displayed in a form. Users cannot add more occurrences if the maximum is already reached.
This means that the minimum and maximum configured by the designer define the boundaries of how rows can be removed and added in Clinic.
Thus, using the same number as minimum and maximum means that a fixed structure is used, always showing the same number of occurrences (assuming no visibility conditions are used) and without the possibility to add/remove rows.
Q: I'm interested in the labels using the dropdown field and the item repeat key. I'm wondering, is the site able to edit the dropdown values that were assigned in Designer?
A: This depends on your configuration.
- If you are using a function, the site staff will not be able to change it.
- If you are using a default value, the site will be able to change it.
Q: Can form-link fields be added in the repeating item group?
A: Yes, form-link items can be used in a repeating item group. However, you cannot use a form-link item that refers to an item collected in a repeating item group.
Q: Can we program repeating item groups with functions to display the Variables with the value we would like to display?
A: Yes, with the use of the ItemGroupRepeatKey this is possible.
Form design – lab forms
Q: If a dynamic structure is used, and sites add rows as needed, can we use a dropdown item to allow them to select an analyte rather than typing in a free text field?
A: Yes, you can use the item type that suits your study and you are not restricted to the item types demonstrated in the webinar.
Q: If I need to change the item names (for example change "RBC" into "Red Blood Cell Count"), what is the recommended approach?
A: This will depend on your configuration. E.g.:
- If you are using a free text field to populate the analyte name, you will need to update your expression to populate the desired text for the desired occurrence.
- If you are using a drop-down item, you can use code list values matching the ItemGroupRepeatKey and then just update the code list label.
Q: What is the practicality of using a repeating item group to ensure that only clinically significant analytes being registered are visible to the site, instead of displaying all 17 analytes?
A: This can be designed in different ways, for both options we recommend using the Reference Data Editor:
- With the use of a dynamic structure:
- A Yes/No question asking whether any analytes were out of range and clinically significant.
- Visibility conditions are set on the repeating item group to display it only when “Yes”.
- repeating item group configured with a dynamic structure (min:1 and max:X) and analytes in a dropdown.
- With this approach, the sites would simply add as many rows as needed and select analytes as relevant.
- With the use of a fixed structure:
- A Yes/No question asking whether any analytes were out of range and clinically significant.
- A checkbox question where sites select which analytes were out of range and clinically significant.
- Visibility conditions are set on the items within the repeating item group, so that the analytes selected in the checkbox item will trigger the correct occurrences.
- A repeating item group configured with a fixed structure (min:X and max:X) and analytes in a dropdown.
- Based on the entry in the checkbox, the correct row is displayed in the repeating item group.
- With this approach, you will lock the ItemGroupRepeatKey to consistently be used for one analyte, but it could be seen as a more complex configuration.
Q: How do you ensure the same order of the analytes across the visits? How do you ensure the same analyte is not selected twice in the same group?
A: The recommended approach would be to populate the analyte name for a specific occurrence. This way you know that a specific analyte will always be placed in the same occurrence and that an analyte will not be selected twice.
Q: Is there a way to use the repeating item group in the design while forcing the names of the analytes to be entered and ensuring that all expected analytes are either completed or marked as “Not done”?
A: The recommended approach would be to populate the analyte name for a specific occurrence. This way you know that a specific analyte will always be placed in the same occurrence and that an analyte will not be selected twice. It is possible to add checkboxes for “not done” or use the system functionality to confirm an item or even a full item group occurrence as missing.
Q: Can you customize the analyte in the same CRF per different visit? As the visits might have different parameters and the sponsors don't want to see extra analytes in the dropdown.
A: The recommended approach would be to populate the analyte name for a specific occurrence. This way, you know that a specific analyte will always be placed in the same occurrence and that an analyte will not be selected twice. If a specific analyte is not required on a specific event, you can use the ItemGroupRepeatKey to populate the specific occurrence only at selected events.
Q: Does the setup of the lab reference ranges change with repeating item groups?
A: Yes, the recommended way is to use a dropdown item to populate the analyte name. In the reference data scope configuration, the “variable type” can be set to dynamic, and the result will be a significantly smaller reference data scope configuration.
Q: In the case that a study does not use reference data scopes, do you have a suggestion how to check if the site uses a unit that makes sense for the analyte in a lab form when you put all possible units in the same dropdown?
A: To start with, our strong recommendation would be to use the Reference Data Editor, since this makes data entry easier. If this for some reason is not used, the options are limited to:
- add validation checks to prevent an incorrect combination of units and analytes, but this would increase the complexity of the setup of the form.
- Simply rely on the site user to select the correct unit, possibly with some custom reports to identify inconsistencies.
Again, our recommendation would be to leverage the Reference Data Editor for this.
aCRF
Q: How will a repeating item group look like in the aCRF (form print)? Will it only appear once or show the minimum number of repeats?
A: A repeating item group will follow the same pattern as other groups and items and will be displayed as it looks in Viedoc Designer, i.e. the repeat icon in the top left corner of the item group will be displayed, but each individual occurrence will not be displayed in the aCRF.
Q: Will all Body Systems be displayed if fixed?
A: All body systems would not automatically be displayed if you are using a fixed structure. However, if you are using e.g. a dropdown list, you will always have the code list displayed in the aCRF, meaning that the aCRF will still display the body systems reviewed (same approach can be used with lab analytes etc.)
Q: Referring to the static text "Body system" it would be very helpful that this text is displayed in the CRF as well.
A: The example with a static text on the first occurrence, replacing a label on the item itself, will result in the static text not being displayed in the “form preview”, but it will be displayed in the aCRF.
Exports
Q: Will these new variables (Item group ID and Item group seq no) be included in items.csv?
A: This depends on the selected export format:
- If the new default is used, each unique item as well as the sequence no. will be listed in the items.csv.
- If the old structure is used, each item and repeat will be listed, i.e. [ITEMOID]$[SEQNO].
Q: If we use the approach with no label on the item, but a static text displayed at the first repeat, will not the missing labels cause problems in the export?
A: No, you can always use an output label to get the desired label in the export.
Q: Will there always be two datasets when exporting, e.g. LBHM and LBHMREPGROUP?
A: Yes, if the new default export structure is used, and a repeating item group is designed, this will result in two datasets – one for the form except the content in the repeating item group, and a separate dataset for the content in the repeating item group.
Q: When exporting data from a form with repeating item groups, will there be any indication in the form export that there is a repeating item group in that form?
A: There will be no indication in the source form, but a separate dataset will be generated (assuming the new default export structure is used).
Reports
Q: Any consequences to existing custom reports?
A: Theoretically yes, but any impact of release 4.92 on custom reports is unlikely. Please see the full explanation in the release notes and the section of breaking changes here: https://www.viedoc.com/support/release-notes.
Q: In case the IDs will have to be used with [ITEMOID]$[SEQNO], will the custom reports work currently after 4.92 update until the next update where that might change?
A: If you design a study with repeating item groups after 4.92, the datasets available in Viedoc Reports will follow the old structure, [ITEMOID]$[SEQNO]. So configuring a custom report based on data in repeating item groups will have to account for this. However, in a release in the near future, Viedoc Reports will be updated to use the new default export structure for the datasets available for custom reports. Any custom reports configured using [ITEMOID]$[SEQNO] will then have to be updated.
CRF updates
Q: Can we use repeating item groups in our ongoing studies?
A: Yes, but careful planning is recommended. Structural changes mid-study will affect exports, integrations, and reporting, so impact assessments should be performed before making any changes to ongoing studies.
Q: I would like to ask about mid-study changes (e.g. additional analyte needs to be added, or number of repeating blocks should be increased/decreased) and possible challenges.
A: In revisions, you can make the same updates to the items that you would be able to do in a non-repeating item group, i.e. you can update settings for the items as well as expressions. You will also be able to increase the minimum and maximum number as well as decrease the minimum number of occurrences of a repeating item group
In a revision, you will not be able to enable or disable a repeating item group, and you will not be able to decrease the maximum number of occurrences of a repeating item group
Q: Once the study went live what are the impacts when we update a repeating item?
A: For revisions, please see above. For fully customizable versions, any changes are allowed. Before enabling repeating item groups in ongoing studies, we recommend you be mindful of how the data will be exported and that changing this mid-study may add complexity
Q: Will this new capability be added to already initiated designs?
A: The option to enable repeating item groups will be added in Designer across all studies at the time of the release.
Viedoc Clinic
Q: is it possible for site staff to delete/inactivate rows?
A: Yes, the site users will be able to remove rows, from the bottom, until the minimum number of occurrences is reached. This is fully audit trailed.
Q: How will the item group repeat key be affected by deleted rows/groups and/or reset of the form?
A: The ItemGroupRepeatKey will be re-used if a new row is later added, e.g. if occurrence number 5 is removed, and later is added again, the new values will also be added for occurrence number 5.
Templates and documentation
Q: Will your examples also be available as templates in Viedoc? (e.g. physical examination repeating mix) These can serve as good examples on how to use repeating items groups.
A: The template studies will be updated with some recommended use-cases. However, if you are looking for examples on how to use the ItemGroupRepeatKey in a design, you can take inspiration from the examples in the design I used during the webinar. This example design can be found here in Viedoc's GitHub repository. Please note that this should be seen as examples only, and that OIDs and other configurations were not reviewed. And before using anything in these designs, please ensure it is properly tested in Clinic so that it works the way you expect.
Q: Will there be an eLearning page on repeating item groups?
A: Multiple lessons in the Viedoc Learning will be updated to account for the new capabilities brought by the repeating item groups.
Q: Can you please explain CDISC compliance in more detail?
A: The new feature repeating item groups is using the CDISC standard ItemGroupRepeatKey to identify each occurrence of the repeat. Using industry standards helps users understand Viedoc designs and export as well as simplify integrations with other systems.
Q: Could you please demonstrate how it has been displayed AE form and now with the repeating group items. Thank you for the informative session!
A: There was no AE form example in the webinar, but repeating item groups can be used in forms in common events as well, they will behave the same way. For example, if you want to capture multiple episodes within one AE, you can use a repeating item group to capture start date (of that episode), severity, action taken etc.
Other
Q: When will repeating groups be supported in Viedoc Coder?
A: This will be in a release in the near future. Work is ongoing but a release has not yet been confirmed.
Q: How is it impacting the study workflow (visit customizations)?
A: The designer will only see the unique items in the event customization in the study workflow. If it is required to trigger specific occurrences based on event, or specific items in specific occurrences based on event, this will be done through a JavaScript expression within the form design.
Q: Any consequences for lab file imports?
A: There is no impact for ongoing lab imports in ongoing studies, since repeating item groups are not used in any ongoing study. For new studies, repeating item groups will bring new possibilities on how to map data in a smoother way. To import data to repeating item groups, the ItemGroupRepeatKey will be used. If data is imported through the Viedoc Import Application, the new version released with 4.92 must be used.
Q: How do repeating item groups impact integrations with external systems?
A: Integrations in ongoing studies will not be impacted, since they have not used repeating item groups. For future integrations it will be possible to both export this data as well as import data to a repeating item group. Since the feature uses the ItemGroupRepeatKey aligned with CDISC standards, integrations are typically simplified. However, downstream systems must be prepared to handle the separate dataset structure (if using the new default export).
Q: How will the SDV be checked for the item repeating group?
A: SDV is defined for each unique item, i.e.– if an item requires SDV, it will require SDV for that item in all occurrences.