a CRF Design Manual Markus Stoll Principle Data

a. CRF Design Manual Markus Stoll Principle Data Manager, Merck KGa. A Global Data Management, Processes & Systems Development German CDISC User Group Kronberg/Ts 2012 -Mar-20

SDTM annotations on CRF § Current Situation – No explicit manual / guideline for SDTM a. CRF 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

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

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– programming skills (concept for terminology and analysis of pdf comments export) § Proposed Timeline (2012) – To have draft guidance on focus 1 by end Q 3 – Ta have draft guidance for focus 2 by end Q 4

Thank you! Markus Stoll, Principal Clincal Data Manager, Standard Librarian Merck KGa. A, Darmstadt Markus. Stoll@merckgroup. com

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(xx. DTC [S. . . ]]) - content/definition&explanation: see guideline --(xx. DTC [S. . . ]]) - content/definition&explanation: see guideline xx. TESTCD=<X> - X out of (a, A, b, B, . . . , z, Z) <X>=V - X in (a, A, b, B, . . . , z, Z)

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

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 – xx. DTC indicates any allowed DTC item from any domain – xx. TESTCD indicates any allowed TESTCD item from any domain