Maybe it’s just a new season. The end of a Boston winter, even a mild winter, is a fine thing. A still better thing is a sensible, forward-looking statement by the FDA in the Federal Register.

Earlier this month, the FDA announced a pilot project to help it figure out how to wean the industry off of PDF-based case report forms (CRFs). Who’da thunk it? Bless their bureaucratic hearts.

We’ve got a link to the document below. On a certain level, there is a wry undercurrent to it. A mild humor. The author(s) didn’t say so explicitly, but they might as well have joked, “folks, in an industry like this, where lives are at stake, frozen electronic snapshots of paper forms make as much as sense as cast-iron horse shoes on a jet airplane.”

For grim, fact-oriented readers, here’s part of what the notice in the Federal Register stated: “Based on our experience, PDF-based CRFs from clinical trials that employ EDC are not ideal to support all review activity. Although the PDF-based CRFs for trials that use EDC can provide a record of the observations collected during the trial (i.e., the data) and additional information about what was collected (metadata), they typically do not provide an audit trail. CDER and CBER are interested in adopting a new, standard format that can replace the PDF-based CRF and that can reliably provide all three components of the CRF in an electronic format: Data, metadata, and audit trail. The ODM is an XML-based standard that facilitates the electronic exchange of clinical trial data, metadata, and audit trail. We are working with CDISC to develop the capabilities within CDER and CBER to review CRFs using ODM. CDISC employed the current production version (Version 1.2) of the ODM on the CDISC website, and we performed some initial testing of limited CRF data in ODM. To help in this development, we are launching this pilot project and seeking sponsors willing to provide CRFs in ODM format to test our capabilities to review these files.”

The announcement will give a few selected sponsors the opportunity to work with the agency. The goal, to recap: refine an electronic counterpart to the hallowed paper case report form that includes metadata and an audit trail. We would not be shocked to learn if a few sponsors had already quietly stepped forward to participate.

It’s worth noticing that this is the latest nudge from the FDA to work with data standards from CDISC, following a much more explicit endorsement of its Study Data Tabulation Model (SDTM). Some of the abbreviations continue to give this reporter a headache, largely because we can’t quite commit them to memory.

For the record, CDISC’s ODM, as its website will tell you, “provides a format for representing the study metadata, study data and administrative data associated with a clinical trial. It represents only the data that would be transferred among different software systems during a trial, or archived after a trial. It need not represent any information internal to a single system, for example, information about how the data would be stored in a particular database.”

The FDA pilot project will take time. PDFs are not going anywhere tomorrow.

But reading between the lines, it’s clear the agency is newly worried about being saddled with digital horse shoes—sorry, saddled with archaic, static, hard-to-aggregate, confusingly named PDFs from clinical trials that are generated by every software vendor and sponsor in the industry. A more explicit migration path away from the PDF is a distant prospect. But the fact that the ODM is on the FDA hit list in a serious way restores our confidence that the industry and the FDA will in time move forward—and not just discuss doing so.

The ODM has more or less received what amounts to a tacit endorsement from the agency. So the pilot project is also a testament to many unheralded CDISC volunteers (and the managers who let them toil in the data standards vineyards).

The full ASCII text of the FDA notice (not the odious PDF, naturally) can be found here. Readers with ODM-savvy tools or services are encouraged to contact the .(JavaScript must be enabled to view this email address).