layout: post title: Define.xml
tags: [SDTM,Clinical Trail]
Background Story:
Once, we need to check a define file, one of my colleagues found many miscellaneous issues, such as punctuation, typos in algorithms, and variable is not on the correct CRF pages. I was surprised by how meticulous he worked. Define file is the critical document while filing an FDA submission, so today we will go over the general structure of Define.pdf/ Define.xml for ADaM and SDTM.
DEFINE.XML DEFINE.PDF ADAM CONTENTS: Study Datasets: INTO1-2021 Dataset, Description, Class, Structure, Purpose, Key, Location, Documentation Individual Datasets: ADSL, ADAE … Variable, Label, Type, Length/Display format, Controlled Terms or ISO Format, Source/Derivation/Method/Comments, Condition Code list: List all the code number and decoded values permitted value, Display Value (Decode) Ex.
*AEDOSCN: dose action 1 dose not changed; 2 dose reduced; 3 drug interrupted; 4 drug withdrawn;
Methods: All the derivation rules ex.
*ADSL.RANDFL if subjects are enrolled and randomized date(RANDDT non-missing) then RANDFL=”y”. otherwise RANDFL=”n”.
Sample Mini ADaM Define.xml Document:
DEFINE.XML DEFINE.PDF SDTM CONTENTS: Annotated CRF, CSRG Clinical Trial Reviewer’s Guide Study Datasets: INTO1-2021 Dataset, Description, Class, Structure, Purpose, Key, Location, Documentation Individual Datasets: DM,AE,VS, EX … Variable, Label, Type, Control Terminology, Origin, Role, Comments Value List: variable, value, label, result variable, type, control Terminology, origin, comments ex. Heart Rate, Diastolic blood pressure…
5. Controlled terms Reference Name, Code Value, Display Value ex. various Windowing rule, test name, and Visit numbers.
Sample Mini SDTM Define.xml Document:
Note: While review the Define files, we need to make sure the variable order is the same as the dataset.
Thanks Manesh, Renee, Cindy, 77’s help so I can put this define summary together.
Happy studying!