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To have draft guidance on focus 1 by end Q3
Ta have draft guidance for focus 2 by end Q4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