duration to create SDTM , ADaM datasets, and TFLs

cuan — Sun, 31 Oct 2021 04:06:37 GMT

Hi SAS community,

I would like to know how many hours you spend to create the next individual datasets, because my budget:

SAFETY datasets:

SDTM

DM (how many hours)

AE. (same as above)

Efficacy:

Then how many hours to create these ADaM datasets:

ADSL

ADAE

ADSV

ADVS

ADLB

ADCM

ADLB

ADTTE

An also, the next TFL outputs:

Listings:

Tables:

Figures:

**please, specify the hours per datasets.

Thank you in advance.

Cuan.

Re: duration to create SDTM , ADaM datasets, and TFLs

japelin — Mon, 01 Nov 2021 01:37:24 GMT

If it's a budget issue, at the very least, there should be information about what kind of data structure and how much volume.

The number of man-hours will vary greatly depending on whether the variable names in the original data are CDASH compliant or SDTM compliant, how standardized the data is, and whether there are standardized procedures or programs, so an estimate without this information is completely meaningless, or rather, impossible to derive.

For example, the difference between generating SDTM from EDC data in rave and creating SDTM data set from Excel data, and whether TFL is 10 tables or 100 tables, you can at least understand that these differences have a great impact on the estimate.

topic duration to create SDTM , ADaM datasets, and TFLs in SAS Health and Life Sciences

duration to create SDTM , ADaM datasets, and TFLs

Re: duration to create SDTM , ADaM datasets, and TFLs