Hi Al,

I work in the Pharma world and am very familiar with the requirements. There is no application 'certified' as compliant because the full 21-CFR-11 Regulation require the specific customized instance of an application to be 'validated', which means fully tested and verified according to a documented in-house quality process (like CMM, RUP, IEE, or home-grown). The applications you mentioned are the 'plumbing' and have the basic technical tools (audit trail, e-sig capability) to become compliant, but each clinical trial requires customization and programming specific to that trial. On top of that, the company running the trial must have standard operating procedures in place to define all aspects of the development process and roll-out.

The tools you mentioned are data management tools, which store the data for analysis after it is captured. Collecting the data via the web can be done with Oracle Clinical or with Phaseforward (www.phaseforward.com), or do a search on 'electronic data capture' for more vendors.

As a side note, I have out together several clinical trial systems using VFP and we able to meet the requirements without too many problems. It ended up being cheaper and faster than licensing some of these systems. Check out my website at www.jagclincial.com for pretty screen caps of a VFP-based clinical trial system.

If you would like to speak more directly, feel free to drop me a private e-mail at rickd@jagsys.net. Or we can keep it public on the UT at the risk of boring other with FDA regulatory requirements :-).

Rick Dochterman


>>Hi Al,
>>
>>21 CFR 11 provides the regulations for the submission of certain required documents in electronic rather than paper form, and permits the use of electronic signatures rather than handwritten signatures to authenticate electronic documents.
>>
>>Exactly what is your questions.
>
>In the clinical trials business, to the best of my knowledge there are only 2 software programs "certified" to comply: ClinTrial and Oracle Clinical. These are expensive - licenses alone start at the $250K ballpark.
>
>It seems the FDA specifically tried to lay out principles it wants followed, rather than specific technologies or implementations. I was wondering if anyone has used either of the above-mentioned programs, or any other "compliant" applications in any other FDA-related industry and could comment on:
>
>- how well these programs actually comply with the "principles" of the regulations;
>- which portions are of most real-world interest to the FDA;
>- if any de-facto technology standards have arisen in response to these regulations;
>- any idea on the steps involved in seeking certification