You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
Your standard operating procedures (SOPs) provide the framework for a well-controlled, compliant clinical trial.
These procedures are so fundamental, you may not have given them a second thought during busier times. Now, with many site activities stalled, your team members are looking for ways to stay productive. There’s no time like the present to revisit your SOPs to ensure they are up to date. Here are a few things to consider as you do.
Topics: Standard Operating Procedures, COVID-19
As monitors, we often encounter sites that utilize Standard Operating Procedures (SOPs) to help ensure clinical research trials are consistently conducted according to FDA regulations. According to the International Conference on Harmonisation (ICH), SOPs are “detailed, written instructions to achieve uniformity of the performance of a specific function.” While most would not argue the value of SOPs when it comes to the successful completion of a clinical trial, it’s important to take a closer look and think about them critically prior to implementation.
Topics: Monitors, Standard Operating Procedures, FDA