If you hoped this would be a post about preparing for an FDA audit, you’re probably not alone. A recent survey of research site professionals reported that over 60% of respondents want more FDA audits training. If you are a member of that majority, I’m sorry to disappoint you. We are going to talk about something with the potential to be far more disruptive to your research site’s operations. And there’s a good chance you haven’t thought much about it.
Like everyone else, I’ve been looking on in horror as a cascade of disasters have ravaged Japan. By most accounts, the Japanese were quite prepared. But CROs are reporting that while their employees are safe and have been accounted for, their operations in northern Japan have been significantly impacted.
Many large CROs made a concerted effort to improve upon their emergency preparedness plans following Katrina and the aftermath of levee failure. But if your research site is like most small and mid-sized businesses, you remain woefully unprepared. According to a recent survey of SMBs by Symantec, half of respondents do not have a disaster plan in place, and less than half of respondents back up their data weekly or more frequently. With the median cost of downtime for SMBs being $12,500 a day, this can be a costly mistake.
Even if your site is one of the few located in an area immune to earthquakes, wildfires, tornadoes, hurricanes or other natural disasters, there are other threats that could disrupt your site operations. You might as well be prepared, especially since it need not cost you much money to do so.
But emergency preparedness will cost you time. And that’s something that many research professionals do not have. With that in mind, the goal of this post is to get you started and make the process a bit less daunting. You don’t need to have a full-proof plan in place. There’s no such thing. But the information in this post can help you put a basic plan together, which you can improve upon as you have time. It’s important to remember that an emergency preparedness plan is a living document.
The First Thing You Should Do
If you do not already back up your site’s essential data, start doing so immediately. It doesn’t take a disaster to result in data loss. In fact, the most common cause of data loss is hard drive failure.
Ideally, your backups should be off-site and automatic. Though many of us have the best of intentions when it comes to backups, this is a task that is very easy to procrastinate. It’s best not to leave such an essential part of your site operations at the mercy of human error, procrastination, or forgetfulness. Several services offer automatic, secure remote backups for businesses at a reasonable price. I personally use Mozy and have been happy with it thus far. And if cost is a concern, just use one of these services to back up your most important files off-site.
4 Major Issues to Consider
Now that the backup discussion is out of the way, I’m going to go over four major issues to consider as you develop an emergency preparedness plan. Contemplating these issues will help you hone in on some more specific questions that need to be asked (and answered) as you work on your plan.
Phone lines quickly become overloaded in the midst of disaster, which can prevent communication for days. What are some communication alternatives? How will you find your employees and patients, and how will they find you? Do you have other contact info in addition to phone numbers? There are a variety of alternative free and low-cost communications solutions, including social media, Skype, teleconference services, and email. You can also set up a special emergency web page on your primary website.
Maintaining Essential Business Functions
Your first order of business will be determining the safety of your employees and patients, and your second priority will be maintaining employee and patient safety. How will you do this? Will you be able to get study medication to patients that are in active studies? Prioritize your most important business functions and determine how you can maintain business continuity.
Getting Access to Essential Documents
In order to protect patient safety, you will also need to have access to certain essential documents. Would you be able to access patient medical records? How about their drug assignments? In addition to important documents related to the conduct of your studies, there is also the issue of basic business documents that you need to function. This might include employee, financial, insurance, or other information.
Maintaining Data Integrity
In addition to protecting your site’s data via backups, you should also consider ways to protect your study data. Many studies still use paper CRFs. Are there any ways you can protect your study binders? What about your samples? Any steps you can take to protect your study data will be much appreciated by sponsors and potentially save you a lot of headaches.
3 Free Emergency Preparedness Resources to Get Started
A variety of free resources exist for businesses that want to improve their disaster preparedness. I’ve selected 3 of the best. Use these websites to help you develop a basic preparedness plan and then you can continue honing that plan as needed or as time allows.
Ready Business outlines practical steps and provides easy-to-use templates for implementing an emergency preparedness plan. Their recommendations reflect the Emergency Preparedness and Business Continuity Standard (NFPA 1600), which has been endorsed by the American National Standards Institute and the Department of Homeland Security.
A variety of publications are available for download, including a sample emergency plan, guidance on the costs of developing a plan, an emergency supplies checklist, an insurance discussion form, and a computer inventory form. The website also provides useful links to resources providing more detailed business continuity and disaster preparedness information.
PrepareMyBusiness.org provides businesses with emergency preparedness resources focusing on education, planning, testing, and disaster assistance. The planning portion of the site has downloadable PDFs to aid in the development of an emergency preparedness plan. In addition, the education section has webinars on many topics, including risk assessment, preparing for hurricane season, crisis communications planning, and disaster recovery best practices.
Red Cross Ready Rating Program
The Ready Rating Program is a self-guided program designed to help businesses and other organizations prepare for emergencies. Participants complete a 123-point self-assessment of preparedness, receive guidance on improving preparedness, update plans based on knowledge gained, and continue the cycle of assessing and planning. The advantage of the Ready Rating Program is that preparedness is measured quantitatively, allowing members to easily identify areas of strength and weakness. Members receive a Ready Rating seal that can be used to publicly display their commitment to preparedness.
Learning From the Past
Since one of the best ways to prepare for the future is by learning from the past, I dug for articles by research professionals who were impacted by Katrina. My favorite of the bunch was an article by Alicia Pouncey of Aureus Research, which is located in the greater New Orleans area. Alicia highlights three lessons from Katrina and has some great insight. I highly recommend you check her article out here: Hurricane Katrina: What Have We Learned?
Hopefully this post will help you institute an emergency preparedness plan for your research site. And I’d love to here some additional suggestions in the comments as well.