ADAM & SDTM specs checks

Get Started. It's Free
or sign up with your email address
Rocket clouds
ADAM & SDTM specs checks by Mind Map: ADAM & SDTM specs checks

1. Check for duplicate variables

2. Structural

2.1. Check if tab exist in specs / Tabs defined in SDTM or ADAM doc (link) should exist

2.1.1. Check if required column exist / SDTM or ADAM required columns should be present

2.1.1.1. Check required columns for null values / null values should not exist

2.1.1.2. Check for hyperlinks / they should not exist

2.1.1.3. Does the order matter?

2.1.1.3.1. Try: change order of columns and see if P21 adapter works

2.1.1.3.2. Try: change order of columns and see if DTS macros work

2.1.1.4. Check for duplicates

2.1.1.5. Highlight non-standard column

2.1.2. Check for duplicates

2.2. Check vs the source for tabs and columns (current template on globalshare/gdsr?)

2.2.1. Do columns/tabs gets renames?

3. Content

3.1. Check if domain matches the spec

3.1.1. Check if variables in spec match the dataset

3.1.1.1. Should we check the label, length, type?

3.1.1.1.1. Check with Ram

3.2. Controlled Terminology

3.2.1. Remove unused codelists

3.2.1.1. Concern: Custom formats

3.2.1.2. New checks to be added

3.2.2. Copy SDTMv codelist (the ones which are referenced in SDTMv domain-level specs) into ADAM spec?

3.3. SDTM(v) specs

3.3.1. Extra Derivation Information

3.3.1.1. 3.2

3.3.1.1.1. Check if "<domain>.Origin" = "Derived" have a link via "<domain>.Extra Derivation Information" in "Extra Derivation Information.Derivation Name" / All derived variables should have Derivation specified in "Extra Derivation Information" tab

3.3.1.1.2. Column "SDTM Derivation" has to be rephrased from standard text to esub-compliant text

3.3.1.2. 3.1.2

3.3.1.2.1. ? / No place for this in specs?

3.3.2. Value Level Metadata

3.3.2.1. Out of scope

3.3.3. Data Level Mapping Processing

3.3.3.1. Not relevant

3.3.4. <domain>

3.3.4.1. Programmer Derivation / Comment

3.3.4.2. Origin

3.3.4.2.1. Clarify what origins mean and determine where to keep information relevant for define.xml (simple rules)

3.4. ADAM specs (ADaM_1.1)

3.4.1. Check CT of Predecessors / Predecessors have to be consistent with SDTM with CT and rest of metadata

3.4.2. <Domain>

3.4.2.1. Check Variable names in spec and whether they match with data (https://github.roche.com/Rpackages/eSubCheck)

3.4.2.2. Check Variable labels in spec and whether they match with data (https://github.roche.com/Rpackages/eSubCheck)

3.4.2.3. Check whether each variable mentioned in "Derivation / Comment" actually exists in SDTM, VADs (sas7bdat), reference datasets (AEG, ACG...). Typo in variable names and SDTMv variable names can be identified. (https://github.roche.com/Rpackages/eSubCheck)

3.4.3. Analysis Concepts

3.4.3.1. Check for duplicate variables

3.4.4. TODO: Adam branch needs expanding on other tabs

3.4.5. TODO: Existing Jennifer's check to be listed here

4. this background - a check to do

5. this background - a fix to do