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aCRF Design Manual German CDISC User Group Markus Stoll

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1 aCRF Design Manual German CDISC User Group Markus Stoll
Principle Data Manager, Merck KGaA Global Data Management, Processes & Systems Development German CDISC User Group Kronberg/Ts 2012-Mar-20

2 SDTM annotations on CRF
Current Situation No explicit manual / guideline for SDTM aCRF set up available Information on „how to“ to be gathered from multiple examples from reg. authorities Wide variety of potential notation terminology, design and implementation technique (comments or direct text) possible Notation is often a manual process (error prone) Cross check (QC) between data, metadata definitions and blank.crf barely possible (if at all) Annotations not machine readable without clear concept on notation and implementation method

3 Proposal for Future… Subteam „aCRF Concept Sheet“
Focus 1: Discuss and gather examples and references from official guidelines Set up manual / recommendation on „how to“ for SDTM annotations in aCRF Focus 2: Discuss concept and requirements for (fully) machine readable annotations Set up manual / recommendation on „how to“ for machine readable annotations in SDTM aCRF

4 Required Small subteam of experienced and motivated German CDISC UG volunteers Preferable experienced in at least one of the following fields: annotation techniques (pdf comments + export) software for annotations (Acrobat, Open Source etc.) regulatory documents (related guidelines) programming skills (concept for terminology and analysis of pdf comments export) Proposed Timeline (2012) To have draft guidance on focus 1 by end Q3 Ta have draft guidance for focus 2 by end Q4

5 Thank you! Markus Stoll, Principal Clincal Data Manager, Standard Librarian Merck KGaA, Darmstadt

6 CRF annotation constraints
Recommended annotation terms and expressions based on interpretation rules D = V d.X[=V] [S d.X=[V] [S...]] [IN D] [WHERE d.X [=V]] d.Xn - d.Xm [in D [WHERE d.X [=V]]] --DTC(xxDTC [S xxDTC [S...]]) - content/definition&explanation: see guideline --(xxDTC [S xxDTC [S...]]) - content/definition&explanation: see guideline xxTESTCD=<X> - X out of (a,A,b,B,...,z,Z) <X>=V - X in (a,A,b,B,...,z,Z)

7 CRF annotation constraints
Current Exception and Exclusion Rules for programmatic QC checks on CRF annotations The following texts with length<=8 are not seen as items and therefore are ignored: CRF / PDF / NOT / USUBJID / DOMAINS / DOMAIN / DATE / SUBJECT / ELIGIBLE/ FOR / STUDY / NO / YES / CHECKED The following left-aligned text will be ignored: ... WHERE ... IF ... AND An annotation is ignored if it contains [NOT SUBMITTED] or variants Any right-aligned text in balanced brackets (any of { }, ( ), [ ] ) will be ignored

8 CRF annotation constraints
Prerequisites for interpretation rules of programmatic QC checks on CRF annotations D required 2/4 Domain name, also 6/8 SUPPDomain name D. required 2/4 Domain name, also 6/8 SUPPDomain name d. optional 2/4 Domain name, also 6/8 SUPPDomain name X,Y item names V item value, with value in balanced quotes (" or ') or… if no quotes, then V is an item, unless X is domain [...] indicates that the text in [] is optional S indicates a separator between expressions (blank, comma, slash, semi-colon) n,m indicates the start (n) or end (m) of a range xxDTC indicates any allowed DTC item from any domain xxTESTCD indicates any allowed TESTCD item from any domain


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