By Clinical Informatics News Staff

September 18, 2014 | The Alliance for Clinical Research Excellence and Safety (ACRES), an international group aiming to unite clinical trial sites around the world under common standards and data networks, has announced that it will begin drafting global guidelines for the accreditation of research sites. Under the Site Accreditation and Standards Initiative (SASI), ACRES has previously met with site managers, regulators, pharma representatives and other stakeholders to hear suggestions about accreditation standards and metrics by which site performance can be measured. Now, SASI participants will produce a document that defines several sets of tiered standards for trial sites, with the aim of releasing a draft in early 2015.

ACRES plans to create standards that allow sites with fewer resources to meet realistic metrics for accreditation, while making greater demands on high-resource sites that host more complex and demanding clinical trials. Standards will also phase in gradually to give all global sites the opportunity to achieve accreditation. Accredited sites would also, in ACRES' vision, contribute data on their performance to a centralized network that can monitor improvements and consider new quality initiatives. "[Sites] should be properly interconnected so that the information that is derived from the process will not only be the data that support the actual clinical trials themselves, but data that can help to improve operations, to improve safety, and to drive integration and simplification in such processes as monitoring [and] regulatory oversight," Greg Koski, President and CEO of ACRES, told Clinical Informatics News in a previous interview. (See: "Building a Global Clinical Trials Network.")

The current plan is to begin accrediting sites in 2016, after finding suitable accrediting bodies to participate in the program. While it is not yet clear what influence accreditation under the SASI system will have on trial sponsors choosing sites, ACRES ultimately hopes to have a global reach in improving clinical trial quality. "If we were able to have, say, 80% of all of the sites globally that are committed to safety, quality and excellence in performance as part of this network, that network could be used by all of the pharmaceutical companies, device companies, biotech companies, as well as academic institutions, public health entities and [others] to do research in a very efficient and safe way all over the world," said Koski.