It doesn’t have to be like this! If your study design is in an ODM-based design tool it becomes possible to integrate with ODM-friendly EDC systems to remove some of the manual processes.įurthermore, if you’re using a study design environment with advanced EDC integration it is possible to automatically build the EDC system. This is time-consuming and error-prone, often taking many weeks over multiple frustrating review cycles. This means someone interpreting the CRF specifications and coding the eCRFs. The problem here is that the EDC build is traditionally a manual process. This is can sometimes be done by sponsors, but more often is handed over to a CRO or an EDC provider. Building EDC systemsĪfter creating your CRF design the EDC database then needs to be built. We can help you make use of CDASH to design SDTM-friendly forms that are optimized for your EDC system. ODM and CDASH together give you the ability to define standardized forms that can be used across EDC systems and map very easily to SDTM. It also makes it simple to convert the collected data into SDTM, greatly reducing the cost of data mappings and conversions. This means there’s a reduced risk of collecting poor or inadequate data. Using CDASH to design your CRFs not only gives you guidelines for what data to collect but ensures that it’s collected in a manner that’s consistent with SDTM. The mission of CDASH is to harmonize your data acquisition with your SDTM submission. The “2.0” version is a major improvement, providing a core model that standardizes how to design forms that are aligned to the SDTM core model and an implementation guide that defines forms that match the domains in the SDTM implementation guide. This is where the Clinical Data Acquisition Standards Harmonization standard (CDASH) comes in. ODM is a data model rather than a content model, meaning it says how you describe forms but doesn’t define any actual standard form content. Here's an example of a form viewed as it would look in Medidata Rave, Oracle InForm and Parexel DataLabs, all generated from a single ODM-based form specification: What you review are the actual forms, so there’s no manual interpretation to introduce mistakes or elongate your study build. What you see is what you get. With advanced EDC integrations, you can design CRFs that use the full capabilities of your chosen EDC system, and view what the CRFs look like instantly at design time. The ODM standard can be extended to support these system-specific capabilities, and Formedix has developed such extensions to fully support study build in many of the leading EDC systems. For example, system-specific layout capabilities and complex edit checks. question text, datatype, controlled terms), with the remaining details being left to the capabilities of each data collection system. The core ODM model standardizes the 80% sweet spot of form design (e.g. You just create the form and the tool does the rest. Thankfully there are form design tools available, so you don’t need to understand XML. ODM provides a standardized way of describing these objects in XML so they can be understood by any system that reads ODM. For the purpose of this article, we’ll focus on CRFs.ĬRFs consist of groupings of questions, controlled terminologies, and some dynamic behavior such as edit checks, conditional logic, and derivations. If you are interested you can read our blog on Everything you need to know about CRFs.Īs mentioned in the introduction to CDISC standards, one of ODM’s primary uses is to describe the data collected as part of a study. They can also take control of their EDC build to save time and money. Standardizing your data collection means greatly reduced future study build cost due to reuse and increased consistency between studies. With the right tools in place sponsors and CROs can define data collection standards while remaining flexible in their EDC choice. Finally, they can be used to drive your data collection system. These forms can then be turned into organizational standards, driving data quality and consistency. Why should you be interested in it? Because it can be used as a standard way to define forms, independent of the data collection system. This post shines a spotlight on the lesser-known Operational Data Model (ODM) standard, which is often overlooked as it’s not required by any regulators. This has largely been driven by regulation, with national regulators such as FDA and PMDA mandating the use of submission standards such as SEND, SDTM, and ADaM. Over the last few years, our industry has become familiar with CDISC standards.
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