Editor’s note: This entry was written by Kathie Clark, former Director, Professional Services at GlobalSubmit. Kathie is now the Vice President of Product Management at Wingspan Technology.
The role of eCTD-ready source documents and their impact on submission timelines and publishing efficiency is a topic that has been debated for many years. There a lot of naysayers claiming that it’s not possible to compel scientists to produce submission-ready documents, CROs cannot be made to comply with requirements, etc.
Although there are different definitions of submission-ready, most people would agree that to be considered submission-ready, a document must be structured according to ICH/regional granularity rules, be bookmarked and internally hyperlinked, have a TOC if required, and have acceptable (preferably standard) headers, footers, and pagination. Others might go further to enforcing standard fonts, margins, etc.
I had begun to think that there was a light at the end of the tunnel when several recent DIA presentations reported that their rate of re-work due to receiving non-submission ready documents had decreased within the span of a year from a number in excess of 50% to less than 5% of submission documents. This was confirmed by the metrics cited during the presentations and panel discussions.
Interestingly, companies took several approaches to ensuring submission-ready documents:
- Company A cited the creation of an SOP assigning responsibility for the submission-ready state of a document to its owner as one success factor. Templates, work instructions, and checklists supported this approach. Non-compliant documents are often rejected, with reports given back to the owner (e.g. rejection due to password protection). Requirements are now written into all CRO contracts. As a result, non-compliance has been reduced from 50% to 60% down to about 5%.
- Company B described the establishment of submission-readiness groups in CMC and Clinical to aid departmental authors as a key factor. Readiness is now at 80% to 85%, a dramatic improvement over previous metrics. They have checklists instead of a governing SOP.
- Company C related the tactic adopted by their group: a filter built into the document management system that prevented the import of non-compliant documents. Although this was announced in advance, when it was rolled out, a significant rate of non-compliance was uncovered, with a negative effect on the EDMS. This got the attention of senior management, who then provided full support for the initiative.
- Company D described a two-step process, the first state being QC of MS Word documents against requirements, and the second stage involving QC of PDFs. This has been a big step for this company, who was very heavily paper-based just a few years ago.
Many sponsors report that source document QC is a tremendously time-consuming part of the submission process. GlobalSubmit 2010 has powerful features for accelerating the QC process, including:
- Detailed error reports that include over 30 new PDF, bookmark, hyperlink, and fillable form validation errors
- CROSSCHECK™, a sophisticated user interface for QC of bookmarks and hyperlinks, which includes information about the source and destination of each navigation element (including the status of the destination document, such as Withdrawn or Replaced), and details about problems associated with the navigation element
- Split-screen viewing of the source and destination, so a reviewer can tell if a technically correct link or bookmark actually goes to the right place
We welcome any new ideas or feedback on how we can help you ensure submission-ready source documents.