The FDA’s draft guidance on the use of electronic records and electronic signatures encourages electronic systems to improve quality and efficiency of clinical investigations.1

The draft guidance, published June 20, 2017, also expands the use of a risk-based approach in validating and establishing audit trails for electronic systems.1

It’s the validation part of the proposed guidance that could introduce a new problem. The draft says that “sponsors and other regulated entities should have electronic systems validated if those systems process critical records (e.g., records containing laboratory and study endpoint data, information on serious adverse events and study participant deaths, information on drug and device accountability and administration) that are submitted to the FDA.”

“It puts responsibility on sponsors,” says Raymond Nomizu, JD, co-founder of Clinical Research IO of Cambridge, MA.

“As a software vendor, I do worry about proposing regulatory liability on sponsors and whether it will make them unwilling to innovate,” Nomizu says. “On one hand, the FDA is encouraging use of electronic systems and integration across systems. But they’re imposing regulatory liability on the sponsors to ensure that the systems and the integrations are validated and working appropriately.”

This creates a disincentive for integration, he adds.

“You can’t really have it both ways,” Nomizu says. “I don’t think the FDA is fully sensitive to how much of a stultifying impact their words can have.”

For instance, if a technology vendor has a new offering that could be an improvement, the sponsor has a disincentive to switch from its existing electronic system because of the need to validate the change, he says.

While liability for electronic technology should be the vendors’ responsibility, the FDA does not have jurisdiction over vendors, which is likely why the proposed guidance was written this way, Nomizu says.

Research institutions also might have responsibility for validating their electronic systems, but doing this could be complicated, says Susan Rose, PhD, executive director of the office for the protection of research subjects at the University of Southern California in Los Angeles.

“The goals of the guidance is to expand the risk-based approach, data trails, and archiving of records,” Rose says.

The guidance says that electronic records should be archived in a way that records can be searched, sorted, or analyzed and have the same capacity as other records when inspected by the FDA.1

This will be a cost that studies need to anticipate, Rose says. “Studies need to save enough money to store data after studies are done.”

The FDA’s guidance also says that processes should be in place to control electronic system changes and to evaluate whether and how much to revalidate with changes. It reads, “When changes are made to the electronic system (e.g., system and software upgrades, including security and performance patches, equipment or component replacement, or new instrumentation), sponsors and other regulated entities should evaluate the effect of the changes and validate the changes using a risk-based approach.”1

The guidance adds that major changes “may require additional revalidation and critical changes could trigger a revalidation of the entire system.”

The FDA will focus on implementation of electronic systems and changes made to the system during inspections. And the FDA recommends sponsors and other regulated entities perform periodic audits, conducted by trusted third parties, of the vendor’s electronic systems and products.1

Validation also is necessary when mobile technology is used in clinical investigations. The FDA states, “Validation ensures that the mobile technology is reliably capturing, transmitting, and recording data to produce accurate, reliable, and complete records. For example, if a wearable biosensor detects a blood glucose level of 87 milligrams per deciliter, the validation should ensure that the value is correctly and reliably captured, transmitted, and recorded in the sponsor’s EDC system.”1

In some ways, the FDA’s guidance is just acknowledging the reality of an electronic future, Rose notes.

“People were doing a lot of [work electronically], but were questioning whether or not it would be okay, so now clinical trials — depending on the intervention — could do a huge amount of the trial electronically,” she says.