We’re digesting our DIA notes from this year’s annual meeting in Atlanta. Still. One of memorable presentations was from Susan Flynn, chief quality officer at Clinsys Clinical Research, a contract research organization. The company has 300 clinical research professionals; its headquarters are in New Jersey.

Flynn speaks with the benefit of 20 years in the industry. She both audits clinical sites herself and supervises those who do. Her presentation zeroed in on electronic data capture (EDC), and what she’s seen over the years in auditing the technology at clinical sites. EDC being used at a site will add to the time needed to audit it, she says.

Her presentation, Flynn added, was not about the regulations, guidelines and good clinical practice (GCP) rules themselves. “It’s going to be the practical application of all of those,” she said. Most sites do have the necessary documentation to show an inspector, Flynn said. But that is not universally the case. Says Flynn: “We do run into sites that are using commercially available systems and the only thing they have is a certificate from the vendor.”

Print Everything

Flynn noted that working with IT support staff at a site can be delicate, even if a CD with the data has been burned and provided in advance. “You can review the data listings. But be careful about the data listings,” says Flynn. “Ask the IT people to put it in a certain order. Don’t get a data dump. If you’re not specific, you’ll be surprised what you get.”

In some cases, a site may be able to lend an auditor a computer. In other cases, there may be a need to print out hard copies to look at. Only in rare circumstances (if a key person is absent) might an audit be canceled. “At what point do you stop the audit and decide to come back?” she asked. “Our philosophy is, we don’t stop the audit. We keep moving on.”

Hybrid Approach

The reality of most data-system audits for now, she says, is they will include a mixture of paper and electronic systems. Preparation, she says, is what allows an audit to proceed smoothly. “Planning is really the key,” Flynn says. “The use of checklists and forms—I can’t stress it enough. It is going to make your life easier.”

She suggested that a great deal of material be requested of the site before the audit. “This is a lot of information to get ahead of time,” Flynn conceded. “But the more information you get ahead of time, the smoother your audit is going to go.”

One Password For The Whole World

There’s nothing that really compares with actually going on site, she says. Passwords, technically, are not supposed to be shared. “The reality is, it still happens,” she says ruefully. “Is there a little sticky note there with the same password, and everyone is using the same password? You want to look for that.”

Sometimes, she reports, it can be illuminating to confirm that procedures from the initial training of investigators for the trial are being followed. Are documents being signed electronically? Is that in fact happening? In short, the real world implementation of technology may not be as neat, tidy and productivity-enhancing as it is sometimes imagined to be.