How exciting, it’s finally time to close the Study! Not so exciting – the task list and documentation required to get things in order.
Many of our customers have CRA’s or other personnel who are responsible for ‘End of Study’ (EOS) tasks when closing out a trial. Most companies have unique policies, procedures, and documentation that must be strictly followed. There are also a number of regulatory processes that must be completed to maintain compliance.
Although specific studies will often have unique activities, EOS tasks will generally fall into one of the following categories:
– Verify subject records for completeness, subject closure, outstanding AE’s, referrals, etc.
– Data entry or verification, query reviews, data analysis, database locked.
– Drugs returned and records reconciled
– Results and specimens processed
– Rental equipment returned
– Notify IRB / R&D, pharmacy, labs, etc. of study closure
– Follow up IRB
– Verify regulatory documents up to date and on file
– Final reports submitted
– Update financial disclosure / conflict
Record Archiving & Retention
– Review for completeness all essential documents
– Keep documents accessible until study monitor / RCO visit
– Close out after visit
– Create Trial masters
– Create Investigator site specific documentation & make available to sites
– Verify the data is not corrupt and is readily available to the site.
– Verify the data would be accessible from the site during a possible audit.
– Verify that site files are not corrupt and are truly accessible at the site and even more importantly accessible through the retention period.
– Regulations indicate that sites should have ready access to trial data for purposes of review at the site.
If you are closing out a study, accuracy and completeness are of monumental importance. Just looking at the above list, you can see that the job can be daunting. There are many different tasks and subtasks on different timelines.
Like anything, when you’re faced with multiple pieces of project on a tight timeline, it’s always good to step back and take inventory. Ask yourself the following:
Do I really need to be working on this piece right now? Can I efficiently process this task with the attention to detail needed? Is there someone else that can help me? Do I even possess the skills and competency required to accurately process this task?
Invariably some of those activities are best left to the CRA as they have been trained in the protocol and therefore have the core competency to ferret out those areas that need more attention. But, unless you’re superwoman or superman, it’s unlikely that you are great at everything and it may be time to recruit some assistance
What can I outsource, where can I reduce my risk, how can I increase the speed of closure, how can I allow more time to work on more studies?
If you’re asking yourself these questions, t’s probably time to look at outsourcing.
Check out my recent blog post on the pros & cons of outsourcing for a list of 9 critical factors to consider.
Having outsourced numerous projects throughout my career, I can tell you that the biggest issue is oversight of the process. Staying engaged and understanding the risks of who you are entrusting your process is a key component of success or failure.
I have found that it’s better to pay a little bit more for professional service from a vendor that has been there and done that; vendors that understand your risk, your timelines, and can flex when you need them.
Over the years, I have learned that having a strong relationship with those vendors are key to success when I need those resources. Similarly, this has helped me understand what our customers need from us. They need to know that as their vendor, we understand their compliance concerns and that we are not going to let them down; that we understand compliance, accuracy, and speed, in that order. It is an absolute critical part of our responsibility.
The take away here should be considering outside resources wherever possible. In addition, vet and on-board a vendor so that you have help waiting in the wings. Finally, choose a vendor that has broad expertise and will give you the oversight that you need to feel confident in the outcome.