Independence Day

Happy Fourth of July! Since we are celebrating our nation's birthday today, I thought it might be nice to reflect on one of the often overlooked aspects of clinical research: the general freedom of research sites to conduct business as they like.

The rules and regulations that all research personnel, from sponsor to manufacturers to research site staff, have to follow are written in such a manner that permits flexibility in site research procedures. This flexibility allows a research site to develop its own operating procedures on all aspects of a trial provided that the site is still adhering to the ubiquitous language of the Code of Federal Regulations and ICH guidelines. One principle of quality assurance in the industry is that originality must be maintained in the research process, so I believe the regulations are written in such a way to permit a bit of creative license on the part of the sites to have unique operating procedures. Sites can, and should, take advantage of this fact so that they can say that not only is their site different from other sites, but also that they have their own procedures to ensure that GCP is being observed, staff is trained regularly, protocol visits are done accordingly, etc. The list of aspects of a research site's functioning that can be personalized is really limitless and every effort should be made to distance sites from other sites' practices in addition to sponsor "mandated" procedures.

I cannot tell you how many times I have been given sponsor provided source documentation to "has" to be used in a study, or forms/training documentation that "have" to be implemented during the conduct of a trial. I realize that a lot of such provided items are there to prevent a site from missing key data points, ensuring that site's document critical study procedures, or even ensure that site staff training is documented adequately during a trial. However if source documents are supposed to be original documentation, and every site is using the same ones, then how is that original? Another important fact that gets lost in the start up process is that sponsor provided source documents may only be designed to capture study endpoints. Just because they are given to you by the sponsor doesn't mean that the documents adhere to your site's SOPs or that you would be protected in the event of an audit. The reasoning for this is simple: source documents are supposed to be the original documentation of a study visit procedures at a site, so they need to be able to paint a complete picture of how the study was conducted. This requires a very detailed set of document, and frankly, most sponsor provided source documents do not provide that amount of detail. This won't make many coordinators happy, but I really think that sponsors should not provide source documents to sites for the reasons described above. Naturally if there are detailed questionnaires to be completed, that's another story because there are many assessments that are not consistently used or available in standard clinical practice.

The take home message here to sites is that you should do everything you can to ensure that you conduct studies according to your own procedures (while still following federal guidelines, of course). This includes reviewing sponsor source documents to make sure that you are covered and modifying those documents, if not, to meet your standards. It's also worth noting that before you do that, you need to consult the sponsor first and let them know the reasoning for the changes. So, go forth and celebrate your Independence!

As a patriotic side note, I would highly recommend reading "1776" by David McCullough, it's an excellent look into the happenings of that famous year in the USA.