BETHESDA, Md. — Inspections by the FDA’s Office of Bioresearch Monitoring Operations (BIMO) will soon become more consistent from one trial site to another thanks to a major program alignment, says BIMO’s deputy director.
FDA staffers are currently being trained and more consistent reviews should be fully in place by 2020, David Glasgow told last week’s 13th Annual FDA Inspections Summit hosted by FDAnews.
The alignment – which began in May 2017 – organized staff into specialized teams to improve communications and training and reorganized BIMO into two divisions, BIMO East and BIMO West. The duties were previously dispersed among the agency’s different district offices – increasing the potential of inconsistencies in trial site inspections.
“We’ve completed what we planned for back to basics” and more advanced training is now in progress, paving the way for more uniform inspections, he said.
Glasgow also offered tips on how to prepare for and ace site inspections. Training of site staff should focus “not just on the what, but on why the compliance matters,” he said, noting that most sites provide training “and yet there are still violations.”
Training should be tailored to individual trial requirements and not just follow standard [good clinical practice] training, he said. Mock inspections with staff are helpful, but sites can also use sponsor audits as a tool to assess compliance, he said.
“If I keep asking you a question 16 different ways, it means I’m not getting the answer I expect,” he said. “It’s OK to ask an investigator why they’re asking the questions they are asking.” But sometimes silence can be the best response if you don’t have the answer, he said.
“Assume all studies will be inspected,” he said, and if you need time to retrieve records, be sure to explain why and “be up front” about the delay.
Each day of an inspection should end with a daily-wrap up session, to ask questions, note any concerns and to plan for the following day. If your site receives a Form 483, ask for clarification to be sure the observations are clear, so you can follow up with the proper corrective actions.
“Don’t let the investigator leave without asking what exactly the 483 was for,” he said, adding it is sometimes possible to resolve the issue before the inspector leaves.
It’s important to respond to a 483 in writing, to recap the observation, offer an explanation, and describe the corrective actions and when they will be implemented, including any SOP revisions and staff training. It’s also important to consider the impact on any ongoing or future trials, Glasgow said.
Even if the inspector doesn’t issue a Form 483 but mentions issues that need to be addressed, “consider a written response” because the discussion items will show up in the establishment inspection report (EIR) so it’s important to follow up with planned fixes, he stressed.
A BIMO inspector will not ask for direct hands-on access to electronic records, Glasgow said. “I want you to get the records,” and to watch that process, he said, noting that inspectors want to see that site staff know what they’re doing and can easily access appropriate electronic documents.
Cassandra Kennedy, global head of regulatory compliance and quality assurance at Covance, offered other inspection tips during the session. She suggested using a story board to map out any usual events or CAPAs so the inspector can quickly see what happened. She also recommended maintaining a duplicate set of any documents the investigator takes away from the site.
“Don’t wing it. Have a procedure for handling audits and inspections,” advised Philip Leese, president of Medical Consultants PA, and former vice president for the medical division at Quintiles’ clinical research unit.
-By Declan Conroy