WASHINGTON, D.C. – April 20, 2017 – Tips from CVM to Streamline Submissions
At the recent SQA Conference, we had an opportunity to meet with numerous representatives of the FDA Center for Veterinary Medicine (CVM). We spoke at length about protocols for data submissions and their review process. Several sessions included significant sections on EDC and submissions.
Highlights from Conversations and Presentations
CVM is pro-technology, seeing the benefits for everyone involved. Their requests for more information come from a genuine interest in learning more. They want to engage in dialogue with sponsors to understand and clarify, not prevent the adoption of new systems.
They are realistic and know there is no such thing as a “perfect study”. Many of the issues raised by reviewers which result in “refusal to review” or “rejection because of incomplete tech sections” could be eliminated if they avoided many of these very common problems:
- Lack of clarity on how data was initially collected. It is difficult to determine if copies of raw data were submitted and where to find that data in the submission.
- Submissions are often made without a full copy of study database as electronic files (XPT or non-propietary XML).
- Files received were not in English.
- Inconsistencies in data when compared to audit trail or PDF copies.
- Data variable formats changing (e.g. date format) when moving from XML to XPT.
- Large files which are difficult to open and review.
- Inadequate documentation of files and incomplete “readme” files.
- Variable description is not clear, missing units or coding description.
- Variable names don’t correspond well to the questions or field labels.
- Insufficient description of data flow from collection through analysis and how it relates to electronic data files.
How to improve your back-end data submissions after trial is complete
- Data recording must be credible corroborated and consistent.
- XML files are preferred, but should be submitted with a “readme” file describing the XML structure and the relationship to the forms the site filled out.
- Avoid large data arrays presented in huge spread sheets. A hierarchy that consolidates patient information by nesting related data simplifies the audit process.
- Provide the audit trail close to the actual variable.
- Provide a summary in the final report to match raw data.
- Document and explain deviations.
- Fully describe procedures with data flow so the reviewer can reconstruct the study conduct.
- Provide data as close to “raw” as possible. (Reviewers will check the study report against the raw).
- While ordinary PDFs are acceptable, they are awkward and there is NO requirement for all cases to be in PDF. However, an annotated Case Report Form (CRF) in PDF format that shows mapping of variables to pages for a single blank case is very helpful.
HTML on the Horizon?
One of the more interesting conversations we had focused on the acceptability of HTML for submissions. While CVM’s eSubmitter does not currently support HTML we were encouraged that many CVM members, including Debi Garvin, Director at CVM, are interested in seeing such a system developed.
We are planning follow up conversations with members of CVM to present a case for HTML to be added to the legal formats for submission.
If you would like to know more about our conversations or the presentations at the SQA conference, please give us a call.
Prelude Dynamics is a global provider of innovative software for conducting both human and veterinary clinical trials. Prelude’s VISION™ software system, the only Clinical Trial Optimization Platform (CTOP) available in the industry, takes EDC to the next level by supporting a continuum of study development options that fully integrate into your workflow through do-it-yourself and full-service custom study builds.
Jim Pedzinski – VP of Business Development
jpedzinski[at]preludedynamics.com – 512-476-5100 ext. 210