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Proper Parenting:  A Guide in Using ADaM Flag/Criterion Variables and When to Create a Child Dataset

Richann Watson; Karl Miller; Paul Slagle

Determining when to use AVALCATy, ANLzzFL, CRITy/CRITyFL or create a new data set can be challenging.  This paper provides guidance on the proper use of these variables or when a parent-child data set option is more feasible.

Considerations in ADaM Occurrence Data: Handling Crossover Records for Non-Typical Analysis

Karl Miller; Richann Watson

In this paper, the authors will discuss the creation of ADaM occurrence data for specific cases outside the common or typical analysis where analysis requires a record in SDTM data, which spans across multiple study treatments, periods or phases, to be replicated for inclusion in non-typical analysis with a record being analyzed under multiple study treatments, periods or phases.

Standardized, Customized or Both? Defining and Implementing (MedDRA) Queries in ADaM Data Sets

Richann Watson; Karl Miller

Standardized MedDRA Queries (SMQs) is a unique feature of MedDRA which provides a consistent and efficient structure to support safety analysis, reporting, and also address important topics for regulatory and industry users.  But there is also the ability outside of the specific SMQs in allowing the ability to develop Customized Queries (CQs).  Within this paper, the authors discuss the proper use of SMQ and CQ and when one should use a CQ instead of an SMQ.

Avoiding Sinkholes: Common Mistakes During ADaM Data Set Implementation

Richann Watson; Karl Miller

When working with ADaM data sets, non-compliance and other related issues are likely the number one source for numerous hours of re-work.  This paper will assist you in creating compliant ADaM data sets, provide the reasoning on why you should avoid “sinkholes”, all of which will help minimize re-work and likely eliminate the need for additional work.

Traceability: Some Thoughts and Examples for ADaM Needs

Sandra Minjoe; Wayne Zhong; Quan (Jenny) Zhou; Kent Letourneau; Richann Watson

One of the fundamental principles of ADaM is that datasets and associated metadata must include traceability as a link between analysis results, ADaM datasets, and SDTM datasets. An ADaM sub-team is currently developing a Traceability Examples Document, showing how traceability can be employed in a wide variety of practical scenarios. As members of the Traceability Examples ADaM sub-team, we are including in this paper a selection of examples that demonstrate the power of traceability in complex analyses.

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