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ADaM IG, May 2008 ADaM Implementation Guide: Its Almost Here. Are You Ready? Sandra Minjoe Principal Statistical Programmer Analyst Genentech, Inc.

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Presentation on theme: "ADaM IG, May 2008 ADaM Implementation Guide: Its Almost Here. Are You Ready? Sandra Minjoe Principal Statistical Programmer Analyst Genentech, Inc."— Presentation transcript:

1 ADaM IG, May 2008 ADaM Implementation Guide: Its Almost Here. Are You Ready? Sandra Minjoe Principal Statistical Programmer Analyst Genentech, Inc

2 ADaM IG, May 2008 Outline Purposes for Analysis Datasets and ADaM Major Sections of ADaM IG Basic ADaM structure ADSL Timing of IG Release

3 ADaM IG, May 2008 Purposes for Analysis Datasets and ADaM

4 ADaM IG, May 2008 Purposes for Analysis Datasets Combine data needed for specific analysis(es) Imputed data Target windows Selection Flags Allow One Proc Away Analysis Generated with minimal programming Allow alternate analysis(es) and exploration

5 ADaM IG, May 2008 Other Needs for Analysis Datasets Provide information How to appropriately use data How to replicate results and explore alternate analyses Convey traceability How variables and observations were derived

6 ADaM IG, May 2008 Purposes of ADaM Combine data across domains Provide derived data Variables and observations used for statistical analyses Provide metadata Explain the analysis and results Provide traceability Back to collected data

7 ADaM IG, May 2008 ADaM and Reviewers ADaM helps the reviewer trace: What you said you would do What you did Why they are different Traceability is important Does NOT replace communication with FDA

8 ADaM IG, May 2008 Major Sections of ADaM IG

9 ADaM IG, May 2008 Major Sections of ADaM IG ADaM Data Structure Standard ADaM Metadata Categories of variables ADSL Implementation Issues & Solutions Columns vs. Rows Examples

10 ADaM IG, May 2008 Basic ADaM Structure A vertical structure One record per subject per analysis parameter per analysis time point Includes observations for Observed values Derived values required for analysis Value-level metadata is needed Allows flexibility Predictable structure

11 ADaM IG, May 2008 Categories of Variables Subject Identifiers SDTM Identifiers ADaM Timing Identifiers (e.g. AVISIT) ADaM Parameter Identifiers (e.g. PARAM) ADaM Analysis Values (e.g. AVAL) Analysis Enabling Variables (e.g. ANLFL, TRTP) Supportive Variables (e.g. --SEQ)

12 ADaM IG, May 2008 ADSL Subject Level Analysis Data Required if any ADaM data is submitted

13 ADaM IG, May 2008 ADSL Content Contains basic subject information Demographic, baseline, disposition data Used as source for these variables in other analysis datasets Has standard names and attributes Tools can be built to use it Use it for Baseline and Disposition table programming

14 ADaM IG, May 2008 ADSL Structure Structure: 1 record per subject Regardless of trial design Allows simple merging with any other dataset Even SDTM Use it for population denominators

15 ADaM IG, May 2008 What goes into ADSL Required variables Study identifiers Subject demographics Population indicator(s) Treatment variables Trial dates Permissible variables Numeric equivalents of flags Stratification variables Treatment duration and compliance variables Other key visit dates and durations Protocol specific event information, such as death/survival

16 ADaM IG, May 2008 Required ADSL Category: Study Identifiers Required variables: Likely from the SDTM DM domain STUDYID USUBJID SITEID Optional study-specific identifiers, e.g: SITEGRP (pooled group of sites used for analysis)

17 ADaM IG, May 2008 Required ADSL Category: Subject Demographics Required variables: Likely from the SDTM DM domain AGE SEX RACE Optional study-specific identifiers, e.g.: AGEGRP (age group) RACEGRP (race group)

18 ADaM IG, May 2008 Required ADSL Category: Population Indicator(s) Required variables: At least one flag Flag for each population defined in SAP Character flag is required Numeric flags can be included Some common example flags: FASFL (full analysis set) ITTFL (intent-to-treat population) PPROTFL (per-protocol population) SAFFL (safety population)

19 ADaM IG, May 2008 Population Indicators: Conversions between SDTM & ADaM * Include only population flag(s) needed for analysis SDTM QNAM Description ADSL indicator variables* FULLSETFull analysis flagFASFL, FASFN ITT Intent-to-treat population flag ITTFL, ITTFN PPROT Per-protocol population flag PPROTFL, PPORTFN SAFETY Safety population flag SAFFL, SAFFN

20 ADaM IG, May 2008 Required ADSL Category: Treatment Variables Required variables: ARM (planned arm) TRTP (planned treatment) Optional study-specific variables, e.g.: TRTA (actual treatment) Use when subject received something other than planned treatment TRTxA and TRTxP Used instead of TRTA and TRTP For when multiple treatment regimens are assigned, e.g., cross-over design

21 ADaM IG, May 2008 Required ADSL Category: Trial Dates Required SDTM variables RFSTDTC and RFENDTC Retained for reference, traceability Required numeric dates RANDDT (if trial is randomized) TRTSTDT (Date of 1st treatment start) TRTENDT (Date of last treatment end) Format to be human-readable If appropriate, instead use TRTxSTDT and TRTxENDT Date-time if appropriate

22 ADaM IG, May 2008 Implementation Issues & Solutions Building Analysis Datasets Step 1: bring in data from elsewhere Step 2: derive new data Columns Rows Step 3: clean up

23 ADaM IG, May 2008 Rules for Rows vs. Columns Add column if all data needed for derivation is in the row Change from baseline Add row if need more than one row to derive new information LOCF, Average across a visit, AUC Add row for transformations that go across all analysis variables Log10

24 ADaM IG, May 2008 After Derivations How much SDTM to keep in AD? Data used to derive analysis variables but otherwise not needed for analysis Consider keeping if: Helps with traceability Easy to subset to get analysis records Extra data will allow for derivation of alternate analyses Keep audience in mind

25 ADaM IG, May 2008 Timing of IG Release

26 ADaM IG, May 2008 Timing of IG Release Jan 30, 2008 Released for internal CDISC review March – May, 2008 ADaM making doc modifications May 30, 2008 Planned date for public review release Late August, 2008 Approximate review due date

27 ADaM IG, May 2008 IG Review Review process will be similar to other CDISC reviews Spreadsheet to collect comments Review can be done by: Company Individual Other?

28 ADaM IG, May 2008 IG Review

29 ADaM IG, May 2008 Summary Purposes for Analysis Datasets/ADaM Major Sections of ADaM IG Basic ADaM structure ADSL Timing of IG Release Questions?


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