Clinical Data Acquisition Standards Harmonization

CDASH

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ardsdevelopment_feb2006.pdf.
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Considerations for CRF Design
Only collect necessary data.
CRFs should avoid redundant data and focus on collecting
only the data needed to answer the protocol questions and
to provide adequate safety data.
Control the process for the design, print and distribution
of CRFs.
Account for unused CRFs.
An adequate review process needs to be in place and
ideally should consist of those involved with the
development of the protocol and the SAP.
All research-related data on the CRF should be referenced
in the protocol to specify how and when it will be collected.
The team developing the data collection instruments
should consider the workflow at the site and the standard
of care.
Standards should be employed to collect consistent data
across the compounds and therapeutic areas.
Rationale and Benefits
It is costly and time consuming to collect unnecessary data.
Only the data that is used for analysis should be on the CRF.
When available the Statistical Analysis Plan (SAP) needs to be
reviewed to ensure the parameters needed for analysis are
collected and easily analyzed.
The CRF development lifecycle should be a controlled process
using a formalized, documented process that incorporates
design, review, approval and versioning steps.
Staff involved in CRF design should review the protocol to
ensure that it is possible to collect the proposed data.
Statisticians should review the CRF against their planned
analyses to make sure all required data will be collected in an
appropriate form for those analyses.
Clinical Operations staff should review the CRF to make sure the
questions are unambiguous and that it is possible to collect the
data being requested.
Scientific experts should provide input on the efficacy and/or
safety data collection fields, and educate the CDM staff on the
type and methods of collecting those data.
Regulatory experts should review the CRF for compliance with
all applicable regulations.
Data Entry is an important user of the CRF and their
perspective should be included in the review.
The CRF needs to be quick and easy for the site personnel to
complete.
The CRF should be designed so that it mirrors the order of the
assessments completed by the site personnel.
Using standards saves time and money across the whole clinical
research process.
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Considerations for CRF Design
Keeping clarity paramount and avoiding leading questions
to influence a site.
Translations of CRFs into other languages should be a
parallel process following the same set of steps with
separate reviews and approval by appropriate experts.
CRF Completion Guidelines:
CRF questions should be clear and not need explanations
so no instructions are needed.
Any instructions that are given should be concise and
should be standardized as much as possible.
Rationale and Benefits
For CRFs, standards:
Questions should be clear and unambiguous. There should be no
bias or errors.
Clearly trials are global and cultural and language issues must be
considered to ensure consistent meaning.
Putting short instructions and prompts on the CRF increases the
probability that they will be read and followed and can reduce
the number of queries and the overall data cleaning costs.
Well-designed Completion Guidelines ensure that there are
decreased data management costs (due to decreased data entry
costs), allow CRFs to have a familiar format, so fields become
recognisable and the format of the page is less cluttered and
makes data entry and review easier.