by M.Fournier Groupe Utilisateurs Francophones du CDISC – 08/02/05

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Presentation transcript:

by M.Fournier Groupe Utilisateurs Francophones du CDISC – 08/02/05 Experience of implementation of this “A harmonized, report-friendly SDTM and ADaM Data Flow” by M.Fournier Groupe Utilisateurs Francophones du CDISC – 08/02/05

Pre-requisites Internal document ADS-SDS on : SDTM 3.1.1 Adam General Consideration 2.0 Work with our standard group so that all teams work in same direction and exchange on these topics Basis : CT4 data (OC just coming) “Strategically” CDISC thought at BS&P level mainly (things changing slowly…) Problèmes rencontrés pas uniquement liés à CDISC mais aux choix “stratégiques” de SA et de la BS&P…

What was done What was NOT done Programmation of “plenty” of ADS-SDS Mainly phase II / III studies (and oncology phase I) Used to run analyses Extraction of “pure” SDS from our ADS-SDS RELREC, SUPQUAL, Trial designs

Main issues encountered… “Forced” controlled terminology Study/project/therapeutic area specificities Content of variables versus reporting Far from a “one-proc-away” principle Interpretation of the recommendations

Main issues encountered… “Forced” controlled terminology CDISC not thought from beginning… Should we “map” and lose the original meaning? 2 examples

Main issues encountered… 1. “Forced” controlled terminology OUTCOM Label in CT4 (or OC) CDISC Submission Value FATAL NOT RECOVERED NOT RECOVERED/NOT RESOLVED RECOVERED RECOVERED/RESOLVED RECOVERED WITH SEQUELAE RECOVERED/RESOLVED WITH SEQUELAE RECOVERING RECOVERING/RESOLVING UNKNOWN

Main issues encountered Main issues encountered… 1. “Forced” controlled terminology (cont’d) Main issues encountered ACTION Label in CT4 or OC CDISC Submission Value NONE DOSE NOT CHANGED PERMANENTLY DISCONTINUED DRUG WITHDRAWN DOSE REDUCED INTERRUPTED DRUG INTERRUPTED NOT APPLICABLE UNKNOWN DOSE INCREASED DELAYED AND REDUCED DELAYED Problèmes rencontrés pas uniquement liés à CDISC mais aux choix “stratégiques” de SA et de la BS&P… ? ? ? ?

Main issues encountered… Study/project/therapeutic area specificities Attach the data to an existing domain or create a new one? What in case of two candidate structures? Should we limit SUPPQUAL data?

Main issues encountered…. 2 Main issues encountered… 2. Study/project/therapeutic area specificities CM CMBORTH … Will go to a SUPPQUAL… CMGRPID

Main issues encountered…. 2 Main issues encountered… 2. Study/project/therapeutic area specificities (cont’d) MH (Use of MHCAT) Convention for dates

Main issues encountered…. 2 Main issues encountered… 2. Study/project/therapeutic area specificities (cont’d) Food intake assessment CDISC has defined ML (Meal Data) – Interventions; Which content for this reserved name? We need to store this data as quantitative results (change from baseline) Should we take a Findings model?

Main issues encountered… 3. Content of variables versus reporting

Main issues encountered… 4. Far from a “one-proc-away” principle Visit Value Bas. EOT 1 23 2 22 Y 3 4 25 5 24 One row needed per timepoint + EOT is one of the Visits xx ! Visit (2) Value Baseline 22 3 23 4 25 5 24 EOT

“Funny and tricky” occupation Not very-very comfortable Conclusion… “Funny and tricky” occupation Not very-very comfortable MERCI!