CDISC

Two Common Programming Issues When Pooling Data from Multiple Studies

T.Y. - Apr 11, 2018 Comments Off

In clinical trial industry, we need to pool data across several trials and combine data from multiple studies into a single dataset. And analyses can be run on the new

ADaM CDISC

Noval approach to derive PARAMTYP and DETYPE for BDS ADaM dataset

T.Y. - Jul 6, 2017 16

For BDS dataset, variables such as PARAMTYP and DTYPE may be required to be created when coming to complicated study. This post will introduce the difference among these two variables

ADaM

Introduction on how to create ADaM

J.L. - Jun 24, 2017 Comments Off

In this post, I will make an introduction on the process of creating ADaM (Analysis Data Model) , CDISC documents and then make a summary of some tips. Flowchart of

SAS SDTM

SDTM TV – How to consolidate all timing variables within a library into one variable

J.L. - Jun 3, 2017 1

Trial Visits (TV) dataset in the Trial Design model describe the planned visits of the study, but it is also necessary to collect corresponding actual data in Subject Visits (SV)

Regulations SDTM

Split Long Text String into Multiple Shorter Parts without Spliting a Word using SAS

J.L. - Feb 25, 2017 Comments Off

Text strings that exceed the maximum length of variables should be handled per the instructions in section 4.1.5.3 of SDTM 3.2. Per the instructions, we sometimes need to split long

Regulations SDTM

SDTM Model Concepts and Terms

J.L. - Feb 24, 2017 Comments Off

SDTM provides a general framework for describing the organization of information collected during human and animal studies and submitted to regulatory authorities. The model is built around following concepts: Observation