Along with sponsors, monitor, and investigative sites, IRBs play a big role in overseeing the conduct of clinical research. Over the past couple years, warning letters have been issued to IRBs at near record levels. Researching and using those warning letters as a tool can be a proactive way to avoid a similar fate.

This white paper provides a random review of warning letters issued to IRBs in recent years and shows 3 key areas in need of improvement including writing procedures, timeliness of continuing review, and adequate documentation.

Are there other areas of improvement that can be added to this list?

We would welcome your thoughts!

This white paper focuses on how the reciprocal acceptance of Good Clinical Practices (GCPs) would facilitate multinational studies and promote the use of clinical data to support regulatory submissions in multiple countries. The white paper was published in the April, 2010 issue of Regulatory Focus, a RAPS publication and was penned by Neal E. Fearnot, PhD, Vice President, Cook Group Incorporated. IMARC's Sandy Maddock was one of many contributors to the article.

The white paper study compares four GCPs important to the conduct of clinical trials in the US and Japan, identified their differences and rated the importance of these differences.

Would the reciprocal acceptance of GCPs help facilitate multinational studies and support regulatory submissions in multiple countries?

IMARC Research will field two teams at MedCity News Cornhole Tournament on Thursday, July 19^th in Cleveland, Ohio at the Gateway Plaza. Fifty teams from Ohio's medical industry look to dethrone the returning champions from Cleveland Clinic Innovations.

For those unfamiliar with Cornhole, is a lawn game in which players take turns throwing cornhole bags (cotton duck bags filled with feed corn) at a raised platform with a hole in the far end. The game has official rules and is a popular game in the Ohio, Kentucky and Indiana areas.

We look forward to a fun event!

In a cyberspace world, where e-mails and text messages are taking the place of face-to-face and telephone communication, it's important to understand the pros and cons of new technology, and realize that the "new" way isn't always the best way. With new technology making its way into every facet of business today, it's no wonder that interpersonal skills have taken a back seat, a point driven home by the following article.

Whether it's cost savings, efficiency, or just plain convenience that we're after, new technology fits the bill, however, what it can't do is provide the human element that is often needed in certain situations. Evident by the fact that every CRA job description has this as a necessary skill set; interpersonal skills are a must in this industry. These skills allow CRAs to build real relationships with sites and sponsors, forming connections that extend beyond a computer screen.

Are we trading in our interpersonal skills for new technology?

I ran across a helpful guide that was posted by the Temple University Health System on ways to improve your written consent forms and other educational documents.  There has been a major emphasis on improving the readability of consent forms by eliminating complex sentence structure and vocabulary and replacing it with simple, plain language.  The goal is to better help the patient understand the procedure to which they are consenting.

What have you done to improve your consent forms?

On August 4, 2010, the FDA issued two comprehensive evaluations providing recommendations addressing three key objectives of the agency's public health mission as it relates to medical devices foster device innovation, create a more predictable regulatory environment, and enhance device safety.

Does this help clarify questions around the 510(k) submission process?

Sandra Maddock, IMARC’s CEO and President will participate on a panel discussion focused on Clinical Data Requirement to Support 510(k)s.  The panel is part of BioOhio’s Regulatory Forum being held on August 17^th at Holiday Inn Cleveland-Strongsville, 15741 Royalton Road in Strongsville, Ohio.

BioOhio's agenda is loaded with FDA officials and industry experts.  Other panel topics will include Corrections & Removals and Drug Device Combination Products.

We hope you can attend.

I ran across a thought provoking article in drudegevcompare.com.  A medical device company can choose to either perform all the steps necessary to develop and market a device, or they can hire a medical device contract research organization (CRO) to perform several or all of those steps.

As business development director of a CRO focused on the medical device market segment, my opinion is probably very obvious.  But, I do believe that CRO’s can be valuable partners in helping medical device companies meet specific FDA requirements.  Our company is a niche CRO, which the article states is a growing trend.

Do you believe CRO’s are a necessary partner?

As monitors and auditors, we have traveled all over the globe.  Certainly from time-to-time, things have gone wrong.  For fun, here is a short collection of travel-gone-wrong. 

Stood up?

A monitor was on a first-time visit to a site.  She went to the hospital where the research was being done and asked the registration desk to page the research coordinator she was visiting.  The receptionist was told that the coordinator was not in her office, and informed the receptionist that the coordinator was in meetings on Monday mornings.  Every Monday morning!  The monitor went back to her hotel and waited to hear from the coordinator.  When she finally did, the coordinator confirmed that she was in meetings, and even stated she never would have scheduled the visit on a Monday!  (The monitor later provided email correspondence confirming the visit days.)  Needless to say, the monitor never scheduled another Monday visit to that site, and routinely IMARC monitors call their sites prior to a visit to ensure the site is expecting them.

That’s not money!

While travelling in Canada, our monitor was tipping the bellhops with Canadian dollar coins.  Or at least, she thought she was.  Later she realized that she was using tokens from her purse instead of her Canadian money!  I’m sure the bellhops were quite pleased with the souvenirs.

But I have a dollar bill!!

Have you ever driven along the toll roads in Illinois?  While the unattended, low cost ($.50) tolls are fast and efficient, if you have no change you are a bit stuck!  One monitor went through the toll and never followed-up.  Well, that $.50 toll turned into a $45 ticket after the rental car company found her!  Another monitor waited for 15 minutes to find another car to come through, so that he could beg for change.  Lesson: if you travel to IL, TAKE CHANGE!

MacGyver-like thinking.

One night in a hotel, a monitor was taking her contact out and it bounced down the drain.  The drain was attached to an S-pipe.  Not willing to go without, she decided that if she had something long enough to reach to the curve and something sticky to pick up the contact maybe the contact could be rescued.  The hangers in the closet were not detachable.  But, her belt was skinny and stiff!  Some chewing gum worked on the end as something sticky.  Once, twice, three times without success.  After a good night’s rest with a prayer and one last attempt, her contact stuck to the gum on the end of the belt and she was able to retrieve it. 

You can’t make this up!

Upon recommendation from a site, our monitor flew into Dulles airport for her monitoring visit.  The only vehicle they had available for rental was a full sized conversion van!  Flying in that morning, she got stuck in road construction on her way from the airport to the site – bad enough that the first day of the visit was missed.  To top it off, on the way back, the van broke down!  After hours of waiting rescue (missing her flight), she was picked up and taken to another vendor to rent a car to return to the airport.  She got to spend an extra night and return home the following day. 

Can you share any of your travel nightmare stories?