Studies

a study is a collection of assets that represent part of the life cycle of a clinical trial for example, a study will commonly contain a visit schedule, forms, terminologies and edit checks that define the edc system used to collect the data, and also datasets that define the sdtm and adam submission 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 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 studies published studies are pre approved studies that are provided by formedix published studies can be imported to your repository from repository settings > published tab once imported, a published study cannot be removed from the repository published studies are read only, to update or edit assets in a published study , you must import the content into a new study creating a study 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 studies is managed by granting roles to user groups to create a study select repository from the navigation bar, then select study select create study 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 study has been created (optional) select a sponsor (mandatory) select a docid 3vxktbrdhnsf8v9ogphcc (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 a study you can only delete a study if it is the first version and in its initial state (for example, 'draft' status, version '1') to delete a study select repository from the navigation bar, then select studies do one of the following select the options icon next to the study you want to delete, then select remove this study open the study that you want to delete, then select the "remove study" icon select yes, i'm sure searching for studies select repository from the navigation bar, then select studies you can enter the study 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 study version label enter the version label of the study this is the free text label that you can use to identify the version of a study name enter the study name identifier enter the identifier of the study 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 study for example, 'draft' owner select the current owner of the study 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 studies opening a study select repository from the navigation bar, then select studies you can do one of the following select the options icon next to study you want to view, then select view click on the study you want to open you can search and filter the list of studies to find the one you want if there are multiple versions of a study, you can view a specific version select the appropriate version using the drop down list in the properties section exporting a study you can export a study or an asset group by clicking the download exports icon when you export a file (asset group) as odm xml or define xml, ryze properties are mapped as follows study identifier becomes study @oid study label becomes study name for studies, protocol title becomes study description for standards, standard name becomes study description for studies, protocol name becomes protocol name for standards, standard name becomes protocol name adding a study to favorites you can favorite specific studies so that you can access them quickly in the future favorite studies appear in the favorites section of your home screen to favorite a study select repository from the navigation bar, then select studies open the study that you want to favorite, then select the 'add study to favorites' star icon viewing the repository log you can view the history of a study 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 study 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 studies you can edit the properties of a study including the label, name, identifier and version label select repository from the navigation bar, then select studies do one of the following select next to the study you want to edit, then select edit open the study that you want to edit, then select the "edit study" icon change or update label , name , identifier , sponsor , program, therapeutic area or version label as required select update if the study is in a non editable state (for example, "production"), it cannot be edited until a new draft version is created the version label is a free text label that you can use to identify the version of a study it appears in the breadcrumbs for a study changing study ownership you can change the study owner if you have the correct permissions to change study ownership open the study you want to view select the "study owner" icon select a name from the list and select assign transitioning studies you can transition studies 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 study select repository from the navigation bar, then select studies do one of the following open the study that you want to transition, then select the " transition this study " icon select the cog icon next to the study you want to transition, then select transition this study 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 studies is controlled through user groups for a study, each user group can have one or more roles that define the permissions of the users in those groups study owners can update permissions and permissions can be updated after a study has been transitioned, see transitioning studies to add a role to a user group open the study 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 study open the study 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 study if a user is the owner of the study, "manager" and "editor" roles are automatically assigned, and will show in the "container roles" column associating libraries associating a library allows you to import content from another source you can associate libraries to, and remove them from studies 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 study you want to associate a library to select the "update libraries" icon select studies from the drop down list (optional) enter the name of the study to filter results select the down arrow icon next to the study you want to associate select the plus icon next to the 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 to delete a draft version select repository from the navigation bar, then select studies do one of the following open the study that you want to delete, then select the "delete draft version" icon select the cog icon next to the study you want to delete, then select delete draft version select yes, i'm sure