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# Clinical Sites Should Review Own Corrective Actions: FDA
- URL: https://www.fdaweb.com/clinical-sites-should-review-own-corrective-actions-fda/
- Published: 2022-02-28T12:00:00.000Z
- Updated: 2026-09-14T17:34:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151252

Clinical trial sites that routinely identify issues of potential non-compliance with good clinical practice (GCP) should review corrective actions (e.g., changes to SOPs or training) to make sure they have fully addressed the non-compliance, ORA Office of Bioresearch Monitoring Operations director **Chrissy Cochran** told a 2/16 online “CDER BIMO GCP Compliance and Enforcement” Webinar.  

“So really ensuring that you go back and make sure that whatever you did to address a problem actually fixed and corrected the problem is something that we frequently see as an issue, she said. “So, yes, training is important. Yes, procedures are important to be standardized. But, you know, we don't want you to forget to test that correction as well, and that is something that our investigators will be looking for when they’re out on an inspection.” Having a system in place that’s going to assess and monitor the effectiveness of those corrective measures is equally as important as making the corrections, she said.

CDER Office of Scientific Investigations director **David Burrow** told the Webinar audience that having a “culture of quality” to prevent serious non-compliance is really important. “We know that it’s an iterative process, and not something where you can just put a bow on it and say: ‘we've done what we needed to do and that as a result everything that comes out of this trial is going to be guaranteed to result in high quality, reliable and interpretable data,’” he said. “It’s not the way it works, right? Building quality into your culture as an organization really requires that continuous assessment, that prioritization, that refinement, that eye on the horizon of the risks that might come up, maybe even risks that aren’t yet present.”

Another important point for clinical trial operations to be successful, according to Burrow, is the need to focus on the awareness of roles across the silos and for all aspects to be fully integrated. “It's the information from the early risk assessment and mitigation work that feeds into the protocol development, and the quality-by-design and critical quality factors which then feed into how you develop and operationalize a real true risk-based monitoring strategy,” he said. “This can’t happen in silos. So the best piece of advice really is to ensure that all parts of that ecosystem understand the dependencies and have the information that they need to really be able to effectively do their part in support of the larger whole quality conversation at the trial and application level.”

Expanding further, Burrow said when sponsors contract out a specific part of a clinical trial operation, the contractors/vendors need the “full and complete information and line of sight on the precursor steps of the risk-based quality management systems... You just can't copy and paste parts of your trial risk management and operations from one trial to another outright. And I think to the extent the individual components might need to be uniquely tailored to the specific studies, those contractors and vendors would really need to be able to have the full access to the precursor steps and all the associated documentation, the quality-by-design analysis, the risk assessments, and the mitigation strategies that all feed into the trial design considerations, and they need to be incorporated into the downstream operations.”

Asked whether European regulators’ reliance on remote inspections will see FDA following suit for bioresearch monitoring inspections, Cochran said the agency’s current authority for inspecting requires it to perform on-site inspections. The remote assessments are voluntary and are used when there are no other options, such as a safety or public health (Covid-19) issue, she said, adding that they are also very time-consuming for the sites. In the future, FDA is considering a hybrid approach where it requests information and documents upfront and then there would be less time on site for agency investigators.

Additionally, Cochran said FDA has updated its Investigations Operations Manual ([Chapter 5](https://www.fda.gov/media/76769/download?ref=fdaweb.com), page 5-88) to give investigators permission to request "read-only” access to electronic clinical trial records and databases. Investigators must first get the firm’s management to authorize the access and then the investigator’s supervisor must sign-off too, she said.