Each TA team will have at least one Clinical TA Expert. The primary responsibility of the Clinical TA Expert is to ensure the appropriate core concepts are identified and that the standards under development are aligned with current medical practice and thinking. The Clinical TA Expert is responsible for completing the literature review for the therapeutic area and working with the Project Manager and the ADaM Representative to compile a reference list. Important sources (e.g. medical association publications, scientific papers, seminal TA articles, etc.) must be included and cited appropriately in the standard.
If diagrams or figures are used in the documents, permissions must be acquired from the author/copyright holder prior to publication. Documentation of permissions must be archived. Any text, diagrams or figures used must be appropriately annotated, using American Medical Association (AMA) format for citation and reference management, and listed in the works cited section. No diagram or figure may be used without the expressed permission from the copyright holder.
- Please see Appendix C for detailed instructions on reference management.
- The CDISC TA User Guide Template contains annotations and bibliography examples.