FA vs SUPPQUAL

Report
FA vs. SUPPQUAL
Facilitator: Riekert Henning, 11 April 2013
Copyright © 2013 Quintiles
Agenda
• Introduction
• Guidelines for Resolution
• Decision Chart
• Some Examples
• FAQ & Discussion
• Conclusion
2
Introduction
• More people are becoming familiar with CDISC and the SDTM data standard
and it seems that it should be getting easier.
• In practice virtually every study seems to have forms or modules that
challenge even the most seasoned CDISC users.
• One of these challenges is the “floating supplemental qualifier” or “lost child”
This situation is not CDISC compliant, so we need to address it !
3
Guidelines for Resolution
1) Does it actually belong in a SDTM domain and not SUPPQUAL?
> Is it actually topic data and possibly just not presented in the same way as other
topic data? Does it have qualifiers of its own?
> It may not be the same class as other data collected on the page, but is still topic
data – perhaps it is Findings About an Event or Intervention. Use the new FA
domain!
2) Is there a not-so-obvious parent?
> Review the context to determine what this data is describing or related to. It may be
related to information in another section of the form or on another form altogether.
Alternately, it may be related to the entire form or be a subject-level qualifier.
4
Guidelines for Resolution
Continued…
3) Is the data actually needed?
> If the data is purely administrative (prompt questions, etc.), it does not need to be
mapped.
> Is the data clinically important or useful for medical review?
> Is the data needed for any tables, figures, or listings?
4) When all else fails: It’s time to get creative
> Perhaps the collection field itself indicates the topic data and a record can be
generated in one of the SDTM domains to link the qualifier to.
> If there is no other solution and you must have this data captured in SDTM, then you
may need to create a custom domain to hold the values from these data fields.
5
Guidelines for Resolution
A few options are available:
Floating
Variable
(“Lost Child”)
Find a Parent
Do Not Map
Find Alternate
Mapping
New Record
in Existing
Domain
Custom
Domain
SUPPQUAL
FA
6
Decision Chart
7
Examples
Example 1:
8
Examples
Example 1 continued…
9
Examples
Example 2:
10
Examples
Example 2 continued…
11
Examples
Example 3
12
FAQ & Discussion
Today’s Panel:
• Sunet Botha – Clindata Biostats
• Yolande van Rooyen – Clindata Biostats
• Amorette Kruger – Quintiles Biostats
• Laurent Marais – Quintiles IPT/DM
• Riekert Henning – Quintiles IPT/DM
13
FAQ & Discussion
Questions
• What does the term ‘Findings About’ refer to ?
a) Data that do not describe an event or intervention as a whole .
b) data that indicate the occurrence of related symptoms.
• The variable, --OBJ, is unique to Findings About. In conjunction with
FATEST/CD, it describes what the topic of the observation is.
How do we determine what goes into FAOBJ and FATEST/CD ?
a) FAOBJ is to link FA to an Events or Interventions domain;
b) FATEST Codelistis findings associated with the event in FAOBJ;
• How are the FA records linked back to the original record ?
a) Record may be linked back via RELREC.
14
FAQ & Discussion
• What does the term ‘Findings About’ refer to ?
a) Data that do not describe an event or intervention as a whole .
b) data that indicate the occurrence of related symptoms.
• The variable, --OBJ, is unique to Findings About. In conjunction with
FATEST/CD, it describes what the topic of the observation is.
How do we determine what goes into FAOBJ and FATEST/CD ?
a) FAOBJ is to link FA to an Events or Interventions domain;
b) FATEST Codelistis findings associated with the event in FAOBJ;
• How are the FA records linked back to the original record ?
a) Record may be linked back via RELREC.
15
FAQ & Discussion
• What does the term ‘Findings About’ refer to ?
a) Data that do not describe an event or intervention as a whole .
b) data that indicate the occurrence of related symptoms.
• The variable, --OBJ, is unique to Findings About. In conjunction with
FATEST/CD, it describes what the topic of the observation is.
How do we determine what goes into FAOBJ and FATEST/CD ?
a) FAOBJ is to link FA to an Events or Interventions domain;
b) FATEST Codelistis findings associated with the event in FAOBJ;
• How are the FA records linked back to the original record ?
a) Record may be linked back via RELREC.
16
FAQ & Discussion
How do we determine what goes into FAOBJ and FATEST/CD ?
17
FAQ & Discussion
How do we determine what goes into FAOBJ and FATEST/CD ?
18
FAQ & Discussion
• What does the term ‘Findings About’ refer to ?
a) Data that do not describe an event or intervention as a whole .
b) data that indicate the occurrence of related symptoms.
• The variable, --OBJ, is unique to Findings About. In conjunction with
FATEST/CD, it describes what the topic of the observation is.
How do we determine what goes into FAOBJ and FATEST/CD ?
a) FAOBJ is to link FA to an Events or Interventions domain;
b) FATEST Codelist is findings associated with the event in FAOBJ;
• How are the FA records linked back to the original record ?
a) Record may be linked back via RELREC.
19
FAQ & Discussion
• What does the term ‘Findings About’ refer to ?
a) Data that do not describe an event or intervention as a whole .
b) data that indicate the occurrence of related symptoms.
• The variable, --OBJ, is unique to Findings About. In conjunction with
FATEST/CD, it describes what the topic of the observation is.
How do we determine what goes into FAOBJ and FATEST/CD ?
a) FAOBJ is to link FA to an Events or Interventions domain;
b) FATEST Codelist is findings associated with the event in FAOBJ;
• How are the FA records linked back to the original record ?
a) Record may be linked back via RELREC.
20
FAQ & Discussion
How are the FA records linked back to the original record ?
21
FAQ & Discussion
• What does the term ‘Findings About’ refer to ?
a) Data that do not describe an event or intervention as a whole .
b) data that indicate the occurrence of related symptoms.
• The variable, --OBJ, is unique to Findings About. In conjunction with
FATEST/CD, it describes what the topic of the observation is.
How do we determine what goes into FAOBJ and FATEST/CD ?
a) FAOBJ is to link FA to an Events or Interventions domain;
b) FATEST Codelist is findings associated with the event in FAOBJ;
• How are the FA records linked back to the original record ?
a) Record may be linked back via RELREC.
22
CONCLUSION
The floating supplemental qualifier is a compliance issue which must
be addressed prior to submitting data. Any “lost children” will be
identified by compliance checking tools such as WebSDM or
OpenCDISC.
A thorough review of mapping specifications can help to catch this
issue up front, but one must be careful in determining an appropriate
solution which adheres to CDISC SDTM guidelines and
specifications, keeping in mind the full context of the situation and the
impact of the modified mapping strategy in terms of programming,
medical review, and regulatory review.
23
Any Other Question ?
24

similar documents