Standards

a standard is a collection of assets that have been defined as an organizational standard standards are used to create consistency between studies, improve data quality and to speed up study design standards are often used to define horizontal slices across the clinical life cycle for example an adverse event (ae) standard may define an adverse event form and its associated terminology and edit checks, along with the related ae sdtm dataset and mappings to it when all the related content is approved as a standard it can then be used to rapidly build studies, knowing that the content is approved and consistent across the clinical life cycle standards and studies group related content into one of the following asset group types data acquisition sdtm datasets send datasets adam datasets proprietary datasets generic published standards published standards are pre approved standards that are provided by formedix published standards can be imported to your repository from repository settings > published tab once imported, a published standard cannot be removed from the repository published standards are read only, to update or edit assets in a published standard, you must import the content into a new standard creating standards when a user creates a standard or study, that user is set as the owner the user can set access permissions for other users admin users can change the owner of a standard or study access to standards is managed by granting roles to user groups to create a standard select repository from the navigation bar, then select standards select create standard enter a label this is a mandatory field (optional) enter a name (optional) enter an identifier this field is automatically populated but you can enter your own identifier this field can be edited after the standard has been created (optional) select a sponsor and program if there are any available (optional) enter a therapeutic area by typing and then choosing from the list you can add multiple therapeutic areas by repeating this step (optional) enter a version label for example, '0 1' select create deleting standards you can only delete a standard if it is the first version and in its initial state (for example, 'draft' status, version '1') to delete a standard select repository from the navigation bar, then select standards do one of the following select the options icon next to the standard you want to delete, then select remove this standard open the standard that you want to delete, then select the "remove standard" icon select yes, i'm sure searching for standards select repository from the navigation bar, then select standards you can enter the standard label in the text box next to and search by label you can also filter your results using the following fields updated use the calendar icon to select a date range version number enter the version number of the standard this is the version assigned by formedix ryze version label enter the version label of the standard this is the free text label that you can use to identify the version of a standard name enter the standard name identifier enter the identifier of the standard therapeutic area select one or more therapeutic areas from the drop down list sponsor select one or more sponsors from the drop down list program select one or more programs from the drop down list state select the state of the standard for example, 'draft' owner select the current owner of the standard if you select more than one option from the drop down lists, an or condition is created for example, if you select 'draft' and 'in progress' from the state drop down list formedix ryze searches for 'draft' or 'in progress' to remove a filter option, click the close icon next to it you can also select clear all at the top of the search screen to reset the search to view your filter settings, select show applied filters opening and viewing standards opening a standard select repository from the navigation bar, then select standards you can do one of the following select the options icon next to standard you want to view, then select view click on the standard you want to open you can search and filter the list of standards to find the one you want if there are multiple versions of a standard, you can view a specific version select the appropriate version using the drop down list in the properties section adding a standard to favorites you can favorite specific standards so that you can access them quickly in the future favorite standards appear in the favorites section of your home screen to favorite a standard select repository from the navigation bar, then select standards open the standard that you want to favorite, then select the 'add standard to favorites' star icon viewing the repository log you can view the history of a standard and you can filter the results or change the columns displayed you can also download a copy to your computer by selecting the download button and and you can filter the results or change the columns displayed to add a filter open the standard that you want to view the history of and select the "view logs" icon select the select a filter drop down list select a filter from the list select or enter information into the contains text box as prompted select add filter repeat steps above to add more filters to change the table columns displayed select the visible columns drop down list select the columns that you want to view click off the visible columns drop down list to close it editing standards you can edit the properties of a standard including the label, name, identifier and version label select repository from the navigation bar, then select standards do one of the following select next to the standard you want to edit, then select edit open the standard that you want to edit, then select the "edit standard" icon change or update label , name , identifier , sponsor , program, therapeutic area or version label as required select update if the standard is in a non editable state (for example, "production"), it cannot be edited until a new draft version is created see transitioning standards and creating a new draft version the version label is a free text label that you can use to identify the version of a standard it appears in the breadcrumbs for a standard changing standard ownership you can change the standard owner if you have the correct permissions to change standard ownership open the standard you want to view select the "standard owner" icon select a name from the list and select assign transitioning standards you can transition standards from one state to another in the lifecycle see metadata lifecycle for more information you may be prevented from transitioning a standard or study from one state to another if you are not in a specific user group to transition a standard select repository from the navigation bar, then select standards do one of the following open the standard that you want to transition, then select the " transition this standard " icon select the cog icon next to the standard you want to transition, then select transition this standard select the state to transition to if you want to transition from an editable state to a non editable state, a warning message will appear select transition the lifecycle and lifecycle transitioning is entirely separate to, and unrelated to change requests updating permissions access to standards is controlled through user groups for a standard, each user group can have one or more roles that define the permissions of the users in those groups standard owners can update permissions and permissions can be updated after a standard has been transitioned, see transitioning standards to add a role to a user group open the standard you want to update permissions for select the "update permissions" icon select a user group from the user groups list select the role you want to assign to that user group from the roles drop down list select add role to remove a role from a user group select the down arrow icon next to the role you want to remove select remove role updating permissions will affect all versions to view permissions select the user group you want to view from the user groups list select the down arrow icon next to the role you want to view permissions for select view permissions viewing permissions you can view the user permissions for a standard open the standard you want to view permissions for select the "view permissions" icon you can set visible column options and you can download the report the viewing permissions report has a column for "container roles" this shows all roles which apply to the user for that standard if a user is the owner of the standard, "manager" and "editor" roles are automatically assigned, and will show in the "container roles" column associating libraries you can associate libraries to, and remove them from standards if you have the correct permissions to do this, you must have the "associate libraries" permission which is set in admin / repository / roles to associate libraries open the standard you want to associate a library to select the "update libraries" icon select standards or studies from the drop down list (optional) enter the name of the standard or study to filter results select the down arrow icon next to the standard or study you want to associate select the plus icon next to the standard or study you want to associate to remove associated libraries, select the cross icon next to the associated library in the associated libraries list you want to remove deleting a draft version you can delete a draft version of a standard to delete a draft version select repository from the navigation bar, then select standards do one of the following open the standard that you want to delete, then select the "delete draft version" icon select the cog icon next to the standard you want to delete, then select delete draft version select yes, i'm sure