The Pursuit of Site Accreditation

Recently, ACRP had the opportunity to attend the Institute of Medicine (IOM) Clinical Trial Site Accreditation Collaborative.  This collaborative was a meeting of the minds on the topic of site accreditation in the United States. The working group consisted of experts in the field of clinical research and leaders within the industry.  It was the working group’s third meeting, but the first that ACRP was asked to attend.

We were thankful for the opportunity to be there and represent our members and those involved in clinical research at sites, AMCs, CROs, and sponsor organizations.  Site accreditation will impact the entire industry, so ACRP’s presence at this meeting, in my opinion, was critical.

The working groups involved in this collaborative did a tremendous job outlining the reasons for site accreditation and the benefits that can be realized across the industry.  I found the presentations extremely interesting and insightful.  The recommendations and outputs of the collaborative will be made into a publication, and once it’s ready, I’ll be sure to post it on my blog so you can all have the opportunity to read it.

However, the collaborative’s work ended there.  The collaborative won’t be the group that carries this initiative forward and there is little clarity as to what the next steps will be.  Clearly this initiative will require capital and leadership from some type of governing body, but both who will govern this and who will fund it remain unknown for a number of reasons.

For now there seems to be industry support of site accreditation by many around the table.  Having said that, I also did hear feedback that it wasn’t a sustainable model, sites would not be able to bear the costs of site accreditation, the standards for accreditation would need to truly impact performance and not just increase red-tape and other, in my opinion, legitimate concerns.

Whether this ever becomes a reality in the United States remains to be seen.  What do you think about site accreditation?  Is it a good idea?  Does it ultimately contribute to the conduct of better research or is it simple bureaucracy?  If you work at a site, would you pursue site accreditation?  If you work for a sponsor or CRO, would you require your sites to be accredited?  I’d love to hear from you and hear your opinions on this.  I’m looking forward to discussing this with you.

Until next time,

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