Gaps and gray areas in federal training requirements wind up putting pressure on principal investigators when the burden rightly belongs on sponsors’ shoulders.

But in practice, says Jan S. Peterson, vice president of regulatory affairs and quality for Global Regulatory Partners, investigators may find themselves taking on responsibility for training the rest of the staff.

In the face of minimal guidance from the FDA or ICH, “the sponsor should be driving this training/training documentation issue using clear, written requirements,” Peterson says. Investigators and sites should be prepared to walk away if they don’t get sufficient guidance and time to train properly.

FDA regulations say only that sponsors must hire investigators “qualified by training and experience.” The ICH E6 GCP guideline says investigators must ensure that all trial staff are “informed about their obligations.”

“If the PI feels there’s inadequate training,” says Dalfoni Banerjee, CEO of 3Sixty Pharma Solutions, “that could mean there are systemic problems in the trial. A lot of systemic problems begin with a simple one: less than effective communication.”

Banerjee says sponsors can open up — and sustain — lines of communication by beginning a trial with a survey of the PIs. Questions such as, “What are your expectations for this trial?” or “What tools do you need for a successful trial?” can bring back all sorts of useful data on PIs’ needs and concerns, especially regarding training gaps.

Sponsor training programs may not completely satisfy the FDA’s idea of adequate training, however. All parties involved in a trial should keep their eyes on that elusive definition, Peterson recommends. “Consider how regulators are likely to look at training documentation. Regulators, or trial monitors, or auditors, are likely to seek evidence that study employees were trained and qualified for their work,” he says. “It’s always a ‘show me the documentation’ world.”

David Borasky, vice president for IRB compliance at WCG Clinical, says most IRBs have “a baseline expectation” that site staff have at least a basic training on human subjects research.

“There are numerous options, and some IRBs will accept several, and others are more restrictive,” Borasky says. “This also goes for retraining requirements.”

He adds that “GCP training is similar, but with that different angle that ICH GCP is not the same as research ethics. It’s really about running a clinical trial to a certain standard, and the primary overlap is in requirements for IRB review and consent, which is covered in human subjects training. Human subjects training typically doesn’t linger on ICH GCP things like record keeping and documentation practices. In the world of sponsored research, this is really more of a sponsor or institutional prerogative than an IRB prerogative.

A growing number of investigators have expressed concern about the gaps in training requirements and training standards that may have a long-term effect on the industry. The constant back-and-forth among sponsors, CROs and sites on what and how to train is creating burnout that investigator advocates call “the one-and-done” problem — PIs that have a bad first trial experience aren’t willing to take on another.

The broader industry is taking notice of the problem. Late last year, the Association of Clinical Research Professionals announced it was drafting recommendations for clearer training rules. Days later, the Clinical Trials Transformation Initiative (CTTI) offered recommendations of their own. Both efforts carried the tacit approval of FDA officials (CenterWatch Weekly, Dec. 3, 2018).