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European Pharmaceutical Contractor
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| Kristof Schellis and Joris De Bondt of SGS Life Science Services consider the highs and lows of putting CDISC SDTM and ADaM datasets into practice
CDISC has offered the medical research industry a standard by which data collection can be measured, which has already led to an enormous improvement for the business world. The FDA is recognising these standards and is encouraging submissions that include SDTM datasets, ADaM analysis datasets and metadata provided in define.xml files. On the other hand, getting a database to the point of full compliance and associated metadata ready for submission to the FDA is a labour-intensive job that requires a clearly thought-out management plan.
USING CDISC STANDARDS FOR A SUBMISSION
The starting point for each submission is to decide which version of the CDISC model will be used for preparation of the data. Ideally, all data will be found in one and the same model in order to avoid confusing the reviewers at the registration authorities. After the choice has been made, it is possible that new models can appear before your submission has occurred. Experience has shown that this is not really an issue, as it is practically impossible to comply with all the latest guidelines. One option is to compose a guideline for your specific situation, where the applicable domains for the planned submission are specified in detail. Such a guideline might be the sponsor’s completion of the CDISC SDTM 3.1.1 model and will contain, for example, the definition for the ‘subject reference end date/time’. One sponsor might have a preference for one definition: ‘The value of RFENDTC equals to the date of last contact’; another sponsor can opt for a definition that fits more closely to the design: ‘The value of RFENDTC equals the date/time of last medication intake’. The many permutations of CDISC creates the opportunity to invent your own interpretation, such as the identification of observations to be flagged as a baseline value. The starting point for each submission is to decide which version of the CDISC model will be used for preparation of the data. Ideally, all data will be found in one and the same model in order to avoid confusing the reviewers at the registration authorities. After the choice has been made, it is possible that new models can appear before your submission has occurred. Experience has shown that this is not really an issue, as it is practically impossible to comply with all the latest guidelines. One option is to compose a guideline for your specific situation, where the applicable domains for the planned submission are specified in detail. Such a guideline might be the sponsor’s completion of the CDISC SDTM 3.1.1 model and will contain, for example, the definition for the ‘subject reference end date/time’. One sponsor might have a preference for one definition: ‘The value of RFENDTC equals to the date of last contact’; another sponsor can opt for a definition that fits more closely to the design: ‘The value of RFENDTC equals the date/time of last medication intake’. The many permutations of CDISC creates the opportunity to invent your own interpretation, such as the identification of observations to be flagged as a baseline value. |
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BIO-Europe Spring® 2012 — 6th International Partnering Conference
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