Emmanuelle Denis M.Sc., MICR Global Health Clinical Trials Research Programme
What is CDISC?
Where do I start?
Secondary Objectives
Other major pre-planned analysis
Keep the end-user in mind so that CRF is quick and easy for site personnel to complete. Also, consider the source data.
Keep the CRF questions clear and unambiguous to ensure that they do not lead Avoid collecting free text as it will require coding before it can be analysed
ALCOA Principle
Data quality refers to the essential characteristics of each piece of data; in particular, quality data should be:
Accurate Legible Complete and Contemporaneous Original Attributable to the person who generated the data
WHO Handbook for Good Clinical Research Practice (GCP) : Guidance for Implementation, 2005
ALCOA Principle
Quality data should be:
Accurate
Trial database accurately captures the source data Any corrections or changes are documented Audit trail!
WHO Handbook for Good Clinical Research Practice (GCP) : Guidance for Implementation, 2005
ALCOA Principle
Quality data should be:
Legible
Clear handwriting on CRFs Do not obliterate information when making changes/corrections All data (including meta-data and audit trails) must be in human-readable form
WHO Handbook for Good Clinical Research Practice (GCP) : Guidance for Implementation, 2005
ALCOA Principle
Quality data should be:
WHO Handbook for Good Clinical Research Practice (GCP) : Guidance for Implementation, 2005
ALCOA Principle
Quality data should be:
Original
Original data (e.g. lab results, study questionnaires Accurate transcriptions of source data
WHO Handbook for Good Clinical Research Practice (GCP) : Guidance for Implementation, 2005
ALCOA Principle
Quality data should be:
Attributable
Who recorded the information Only designated study staff should have access to data Audit trail!
WHO Handbook for Good Clinical Research Practice (GCP) : Guidance for Implementation, 2005
References
Food and Drug Administration (FDA). Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application. 2003; Available from: http://www.fda.gov/CDER/GUIDANCE/5667fnl.htm
CDISC. Clinical Data Interchange Standards Consortium. Available from: http://www.cdisc.org/about/index.html CDISC. Clinical Data Acquisition Standards Harmonization (CDASH). 2008; Available from: http://www.cdisc.org/standards/cdash/index.html Fegan, G.W. and T.A. Lang, Could an open-source clinical trial data-management system be what we have all been looking for? PLoS Med, 2008. 5(3): p. e6 Mats Lrstad, Data quality of the clinical trial process - costly regulatory compliance at the expense of scientific proficiency. The Quality Assurance Journal, 2004. 8(3): p. 177-182 Knatterud, G.L., Guidelines for Quality Assurance in Multicenter Trials A Position Paper. Controlled clinical trials, 1998. 19(5): p. 477 Baigent, C., Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clinical Trials, 2008. 5(1): p. 49