Co-founder of Menken Trials | Devoted to finding ways to increase clinical trials efficiency
📝✅ CRA Challenge #7: The Critical Role of Follow-Up Letters in Monitoring 🕒🔍 Let's shift our focus to a key part of monitoring in clinical trials: follow-up letters. These are the letters we send within certain amount of days after monitoring visit, and they're more important than they might seem at first. Initially, I didn't see much value in these letters. They often repeated the same information from visit to visit, just with different action items each time. But everything changed after a tough audit experience. I understood that the sticky notes I left at sites for corrections are being thrown away, and there will not be any record of my instructions. This was a wake-up call about the power of good documentation. In our field, there's a saying: "If it's not documented, it didn't happen." What about you? How do you view follow-up letters? Do you find them useful for you and the sites you work with? Any tips or experiences you'd like to share would be great for all of us to learn from. Let's discuss how we can use these letters effectively! #ClinicalResearch #CRAChallenges #Monitoring #Documentation #ClinicalTrials
Follow-up letters are important in clinical trials because they provide a summary of the findings and actions taken during the interim or close-out visits by the monitors. They also help to ensure the quality and integrity of the data collected, the compliance with the protocol and regulations, and the safety and well-being of the participants. Follow-up letters can also give insight into the oversight and availability of the principal investigator and the study staff, and identify any issues or concerns that need to be addressed or resolved. According to a systematic review protocol, post-trial follow-up methods vary depending on the type and duration of the trial, the outcomes of interest, and the resources available. Some of the common methods of post-trial follow-up include surveys, interviews, focus group discussions, linkage to administrative databases, and use of patient registration. Post-trial follow-up can provide valuable information on the long-term effects and safety of the interventions tested, as well as the perspectives and experiences of the trial participants.
Yes, I find follow up letters extremely functional practice to know the trail of my open action items (keep crossing the tasks completed). and as per the golden rule of Clinical research, "If it is not documented it did not happen". follow up letters are crucial 😀
Compliance Program Administrator @ W3R Consulting | Regulatory Compliance and Implementation
10moDuring my time as a regulatory analyst at a large AMC, follow-up IMV letters played a crucial role in ensuring protocol compliance and accountability. In other words, these letters serve as feedback that sites need to act on. The most effective follow-up letters were concise and well-organized, clearly detailing each issue or deviation, identifying the responsible party, and setting specific resolution deadlines. They were distributed to both me and the PI and CRC via email. Each letter listed action items with brief descriptions and designated responsible parties, aiding clarity and efficiency in compliance. Besides emailing these letters, I also filed them in our eReg binder and communicated the required actions and deadlines to all involved parties. This was particularly important because email notifications alone can sometimes fail to convey the urgency of tasks. Our system was designed to reduce information overload and effectively organize critical tasks and actions. However, receipt of the follow-up letters was essential in ensuring protocol compliance.