26 April 2021 News
Data managers all over the world come across this question: how to handle the codes already assigned to eCRF terms when the next MedDRA / WHODrug version becomes available. And what to do if this happens again and again because the study lasts for years.
An ongoing study keeps the data live – you never wait till the database lock time to start coding as the codes are widely used for reporting adverse events and concomitant medications, performing routine data reviews, preparing safety listings for DSMB sessions and interim analyses, etc.
FDA recognizes that standards development organizations may release version updates to standards in the interval between the start of a study and the submission of study data to the Agency and encourages sponsors or applicants to use the current version of MedDRA / WHODrug / LOINC by the time of data submission. This is particularly important for meta-analyses pulling data from multiple studies and using the global version control.
AE coding with MedDRA, according to FDA Data Standards Catalog, is required by the Center for Drugs (CDER) and the Center for Biologics (CBER). It is also used by the Center for Foods (CFSAN).
Typically, WHODrug Global is used to code concomitant medications. The variable --DECOD should be populated with the active substances from the WHODrug Global Dictionary, and --CLAS populated with the drug class.
The Catalog clearly states the dates that the terminology standard version requirement begins and ends, for both MedDRA and WHODrug.
In 2020 we have witnessed the importance and criticality of the MedDRA dictionary up-versioning as the new disease caused by COVID-19 brought in a big challenge for ongoing and starting studies.
MedDRA and WHODrug providers offer web-based tools comparing older and newer versions of the dictionary so the datasets with coded data can be converted to the current dictionary version.
To facilitate the cross-functional team’s work, Data Management 365 has developed a powerful and regulatory compliant system MainEDC™ that allows to code eCRF data with MedDRA, WHODrug, and other dictionaries like ATC, ICD-10, directly from EDC. The team usually includes Investigators, CRA, Data Manager, Medical Coder, and Medical Monitor, united by workflows with separated query dialogues enforced.
It is very convenient to assign codes from the chosen version of the dictionary via a built-in coding tool, see the eCRF data, and raise queries, where required.
AI-based automated coding is also enabled.
The workflow incorporates a quality control step where a Medical Monitor / Medical Reviewer checks the coding results and prompts the coder to corrections.
As a result, you have the consolidated clinical database export with the coded data, available in real-time mode.
Data Management activities presume AE coding results reconciliation with the external Safety database / Pharmacovigilance system. The other and better way is to integrate the systems so that the clinical data and codes can be exchanged and reconciled instantly.
DM 365 has been a software partner of the MedDRA provider (MSSO) and WHODrug provider.
We have been compliant with the data exchange and licensure rules while working with a great number of CROs and Sponsors.
In 2021 we have made the next step toward higher usability of MainEDC™. Now it is possible to upgrade the MedDRA and WHODrug version in an ongoing study, detect and re-code only those data that have shown a conflict between the codes assigned and the new dictionary version. You can do that directly in EDC where the data reside, and the full range of automated tools is at your disposal.
Therefore, DM 365 proudly offers a validated integrated system that helps you resolve all the difficulties you may encounter while managing clinical data and preparing them for regulatory submissions.
26 April 2021 News
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