Best Practice for Organizing your Standards/Studies

this guide covers suggested best practice when managing content in your clinical metadata repository (cmdr) the examples described in this guide outline how users typically manage content in the system these guidelines are only a recommendation for more information on how to configure your own repository, please speak to the mailto\ support\@formedix com why are standards important? standards are often used to define horizontal slices across the clinical life cycle for example, an adverse event standard may include an adverse event form associated terminology and edit checks a related ae sdtm dataset and mappings when all the related content is approved as a standard, it can then be used to rapidly build studies the standardized content is approved and consistent across the clinical life cycle storing in ryze, standardized content is divided into assets (for example, forms, datasets, terminologies and so on) size matters how you store your content depends on the size of the content and how the content is to be used for example, a standard might contain a small number of crfs relating to a particular therapeutic area or a standard might be a global standard that is used for submission ready datasets and organizing large sets of study data each of these standards might be managed differently, as standards which are frequently updated should be kept small in number for example, questionnaires should be stored as a separate standard as they may be used under license from other companies be consistent when storing your assets, it is a good idea to use human readable naming conventions and aim for consistency across the system when creating a standard you may want to include the following label this should be a simple, human readable label for the standard for example, cdash nci, or demographics crfs this is the text that is displayed when browsing the standards in your repository name this can be used for any proprietary naming conventions identifier this should be an abbreviated version of the label or name for example, for a collection of demographics forms; the identifier should be dm version label when creating or editing standards, it is good practice to add or update the version label for example, for the first version; you could add the date as a version label (01 july 22) when you create a new draft or update the standard, you can add the new date to make it easier to track changes to the standard within standards, assets are organized into asset groups you should group asset groups by type, such as crfs, sdtm datasets, adam and so on see, docid\ z xijkcwtkkyl69ptnfpa organizing efficient storage helps with searchability of your content as well as traceability when working with derived assets organize by using tags when organizing your standards or studies you might want to organize content by using tags for example, you can use a tag for a specific therapeutic area (ta) this allows you to filter content by ta ryze includes some therapeutic areas by default but additional or more specialized ta’s can be added by an administrator organize by project you can also choose to organize content by project where you group all content related to a specific project under one standard create subsets of published standards ryze provides published standards such as nci controlled terminology as these standards are quite large they can be difficult to work with if you are copying or importing them frequently one of the things you can do with published standards is copy them into another standard with this method, you can subset published terminologies into your own version the subset can include a smaller set of your commonly used terminologies or can be extended to include things like sponsor defined terms you can also include sponsor defined terminologies in the same standard, making it easier to manage your terminology standard versioning versioning your standards can help track and keep up to date with proprietary and industry changes how you manage versioning can depend on the content for example, for a global standard that is widely used, you might want to have the content peer reviewed before making it available in your repository you can configure docid 7xsbhlbictwknx4bfp6n2 https //community formedix com/kb/articles/6 lifecycle and docid 6buuiuqqdi6iara77qxes to manage reviews if you're working on something smaller like a dm form that is not widely used, you might not need to peer review and can publish a new version as soon as you update retire old standards it’s good practice to retire old versions of standards by using the not in use lifecycle status, this is important to prevent out of date content being used in studies for example, if version 3 of a standard is updated to version 4, you might want to retire the out of date content in version 3 version and subset versioning can be used with subsets of a standard for example, a subset of a global standard might have a version that is used with a third party this provides traceability back to the parent global standard tips on working with studies standardize as much as possible you can have many assets in a standard and sometimes you have content that is study specific, such as a new covid 19 form the question is whether this form is going to be used only with this study or can you standardize the content of the form you should try to keep as much of your content standardized as possible peer reviews and internal discussions can help determine if there should be a link between a study and standard you can develop a form as part of a study but if the form is often reused then the best practice is to rewrite it as a standard naming conventions it is important to use consistent naming conventions in your cmdr as ryze allows the use of duplicate identifiers across the system care should be taken to distinguish between similar content, the following properties can be used to help differentiate between studies protocol title use a long descriptive name for the study study label study label should relate to your code base version label this can be milestone based, for example, “initial draft”, “final analysis” or “interim analysis” see also, https //www cdisc org/standards/foundational/cdash/cdash model v1 2 use rules rules define how standardized content is used in subsequent studies for example, how a form is used in a study can be configured in the parent standard see docid\ dbt8tgyjtza6pjsxp2c q , for more information