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Requirements for Clinical Study/Trial data in OHDSI


(Waqar Ali) #21

Hi All, I am looking to map a clinical trial dataset in SDTM to OMOP CDM and was wondering if there are any resources to help get me started? The SDTM dataset is from a safety study, and contains AE and EX tables among others. I understand that there is a Clinical Trials WG that has worked on some recommendations - is there any update on how those might be taken forward? (or any example implementations). I am relatively new to OHDSI, so apologies if this is not the most appropriate thread for this query!


(Katy Sadowski) #22

Hi there! There is indeed a CT WG; we meet every other Friday at 10AM EST and welcome new members. Our leader @sonia should be able to set you up with an invite if you’re interested.

In the meantime, you can check out the conventions we’ve proposed on our GitHub Wiki here: https://github.com/OHDSI/ClinicalTrialsWGETL/wiki


(Waqar Ali) #23

Thanks @katy-sadowski!

Yes, it would be great to join the CT WG meetings, kindly add me to the invite list. Thanks also for pointing me to the proposed conventions. Are these currently under discussion, or can one go ahead with implementing these locally?


(Katy Sadowski) #24

The conventions are still under review with the CDM Working Group, and the CT WG is currently in the process of testing them out for the first time on an SDTM dataset. You are welcome to use them as a guide (and of course join the conversation with the WG!) but should consider them to be in “pre-release” status.


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