Introducing the DIGR-ACT® Solution! Part 7



What does ‘T’ stand for?

Everyone talks about learning from when things go wrong. People say it's the best way to learn. But it's not always easy. The DIGR-ACT® solution gives you a way. By taking you through the issue to the root cause, actions and then making sure the actions work, you have learned from the issue. Maybe your learning can be transferred to others? Perhaps the same problem happens to other people too?

Introducing the DIGR-ACT® Solution! Part 6



What does ‘C’ stand for?

Do you care whether the actions you took to try to stop an issue from recurring were completed? Does it matter if they actually worked? Of course! Deciding on actions is only part way to fixing a problem. We need to complete the actions and make sure they were effective. That's why there is the ‘C’ step in the DIGR-ACT® solution, where C stands for ‘Check’.

Exciting Announcement! “The CRC’s Guide to Coordinating Clinical Research, Fourth Edition” to be Released Soon



We are excited to announce Sandra “SAM” Sather’s most recent contribution to CenterWatch, “The CRC’s Guide to Coordinating Clinical Research, Fourth Edition,” will soon be released. The guidebook engages the learner by providing relevant information backed with regulatory sources, frequently asked Q&A, case studies, tools like logs and checklists, and sample forms and SOPs.

Comment Now! Enhancing the Diversity of Clinical Trial Populations (Draft Guidance)



The Food and Drug Administration (FDA) released a draft guidance “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs”. It is the position of the FDA to enroll subjects who are the target audience for the investigational product once approved. Certain populations are underrepresented in clinical trials, even though they are part of the target audience. The draft guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).

Introducing the DIGR-ACT® Solution! Part 5



What does ‘A’ stand for?

Don't waste time on root cause analysis, at least not if you won’t use the results! Proper root cause analysis takes effort and resources, and you need to use the output to determine actions to try to stop the issue recurring. This is the ‘A’ step of the DIGR-ACT® solution. Having dug into the issue, you now need to ‘Act’ on what you found.