Following on from our previous blog posts on Integrated Summary tips, another aspect that can be considered is the cost and quality of producing integrated summaries and how CDISC and CDASH can aid in reducing costs and improving quality for ISS ISE submissions.
Some factors that may reduce cost include, but are not limited to, the following –
- Make all studies similar in structure (e.g., CDASH format as standard).
- Make full use of available macros. Standardise reporting across the clinical program for efficient re-use of macros, along with standard formats for tables, listings and figures.
- Supply all data as CDISC SDTM SAS transport files or SAS datasets. Integrated summaries based on SDTM and AdAM domains provide a platform for FDA submission.
- Supply clean and complete data.
- Code all studies to the same dictionaries and same version.
- Prepare submission-ready documents throughout the project lifecycle, applying consistent style and formatting.
- Reduce the number of review cycles and agree the key messages upfront.
There are several recommendations that can be made when performing quality control of integrated summary studies.
Preparation of Datasets/Domains
- Carefully check data received for validity, appropriateness and completeness.
- Where mapping to SDTM is required, use double programming as part of the QC methodology.
- Note the version of SDTM in all programming.
- Note the version of MedDRA where applicable.
- Ensure all SDTM domains created follow the same version of IG..
- Create an SDTM Data Warehouse for each required domain.
- eCTD requirements: Create define.xml, blankcrf.pdf & SAS transport files.
- Ensure define.xml is created for all studies plus an overall define.xml for the ISS/ISE.
- Agree level of hyperlinking on blankcrf.pdf.
- Agree style and formatting requirements and include checks for same on document QC checklists.
Integrated Summary Analysis Plans
- Allow for multiple reviews to ensure high level and full team input to minimise late changes on the critical path.
- Produce a QC plan documenting level of QC, type of QC and documents to QC against.
- Document all QC stored electronically for ease of team reference.
- Ensure that the differences between dictionaries and study level summaries are documented carefully.
Taking these factors into consideration should aid in producing quality integrated summaries for regulatory submissions at a low cost. CDISC SDTM domains as mentioned are important in this process as the FDA recommends submissions to be made in this format.
Related Blog Posts
- Integrated Summary Tips
- Integrated Summaries of Safety & Efficacy for Regulatory Submissions
- Creating Custom or Non-Standard CDISC SDTM Domains
- CDISC SDTM v3.1.2 Theory and Application