Re: How do we merge CM(Conmeds) and AE(adverse events) datasets?

RAVI2000 · Posted 01-23-2021 06:25 PM

How do we merge CM and AE datasets?
Can you specify exact merge condition?
Do we get any notes or warnings in the log?
In what situation we merge CM and AE? What are the variables that you are going to use while merging from CM and AE?

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mkeintz · Posted 01-24-2021 03:02 AM

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singhsahab · Posted 01-24-2021 09:20 AM

@RAVI2000

It’s depends upon requirement type as per study protocol…

Below are some criteria which you can try based on your study protocol/study eCRF design…

Based on subject number if there is not specific variable present into CM with respect to AE
Based on subject number and AE sequence number if considered into CM
Based on Subject number and AETERM if AETERM considered into CM

RAVI2000 · Posted 01-24-2021 02:02 PM

Can you please provide me an example? or a situation?

RAVI2000 · Posted 01-26-2021 11:42 AM

Is this merging at SDTM or ADaM level?

blueskyxyz · Posted 01-24-2021 10:01 AM

1. Refer to the eCRF, is there any clue? RELREC? the link variable

2. see AE and CM in EDC

3. ask DM

RAVI2000 · Posted 01-24-2021 02:03 PM

How do we merge them if there is any link? what variables do we use for it?

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