Conformant collection and representation of tobacco product study data is ensured by full adherence standards per this guide. When this is not possible.... At a minimum, the following guidelines must be followed.
Guidelines for Data Collection
Determining whether a product faithfully implements a standard or specification is essential to creating robust, interoperable solutions. Specific points for assessing and to take into account when practicing for conformance are below
Standards for Data Collection
The following guidelines should be followed to ensure implementation of CDASH compliant CRFs
| Metadataspec |
|---|
| Guidelines | Description |
|---|
| 1 | Core designations must be followed. | - All Highly Recommended and applicable Recommended/Conditional fields must be present in the CRF and/or operational database. Match language in metadata description
| | 2 | CDISC Controlled Terminology must be used. | - Specified controlled terminology must be used to collect the data in the CRF. All codelists displayed in the CRF must use or directly map to the current published CDISC CT submission values, when it is available. Subsets of published CT, such as those provided in CDASH terminology, can be used.
| | 3 | Best practices for CRF design must be followed. | | | 4 | The wording of CRF questions should be standardized. | - Specified Question Text or Prompts must be used to ask the question per associated guidance.
| | 5 | Variable naming conventions should be used in the operational database. | - Variable naming conventions should be included in the operational database as specified in this guide.
| | 6 | Data output by the operational database into a tabulation dataset variable should require no additional processing if the CDASH and SDTM variable names are the same. | - An SDTM data programmer should be able to assume that data in an SDTMIG variable is SDTMIG-compliant. Minimal processing (e.g., changing case) does not affect conformance. This helps to ensure a quality deliverable, even if the programmer is unfamiliar with data capture practices.
| | 7 | Validated questionnaires, ratings, or scales must present the questions and reply choices as validated. | - his must be followed to maintain the validity of a validated instrument. (See Section 8.3.12, QRS - Questionnaires, Ratings, and Scales).
- In some cases, this may result in CRFs that do not conform to CDASH best practices; however, restructuring these questionnaires should not be done because it could invalidate them.
- The use of such questionnaires in their native format should not be considered to affect conformance to CDASH.
|
|
...