The pursuit of optimizing the clinical trial process frequently relies on the intense effort to manage the trial project with a clinical trial management system (CTMS) and the thousands of regulatory documents through an electronic trial master file (ETMF). What we’ve seen as an unmet need is how to optimize Investigator Site Files (ISF) management at trial sites.
Clinical research trial sites are the physical location where drugs, medical devices and other therapies are tested on human subjects. Sites can be any qualified location from a single physician-owned practice to a major academic medical center. For any site to maintain compliance while running clinical trials, they must practice good record keeping in their own document management repositories and investigator site files (ISF), whether in paper or electronic media.
So, who ensures that this happens? In a previous blog, we’ve talked about the unsung heroes that monitor trial conduct. Monitors, sometimes known as Clinical Research Associates (CRA’s) are the frequent flyers of the Clinical Trials world. By definition, their job is to monitor that the study is conducted and data handled in accordance with the protocol, Good Clinical Practice, and applicable ethical and regulatory requirements. That requirement has them hopping on lots of planes to visit sites and check binders filled with site regulatory documents. Yes, you read that right – actual physical binders. Sponsors and CROs must send Monitors out to sites to audit these binders to ensure all required documents are on file at the site and are reconciled with the trial master file (TMF) at the sponsor or CRO. There are many tasks to accomplish during a monitor’s visit and reviewing the regulatory documents requires a substantial time commitment.
Meeting the Unmet Need
Ok, so not everyone still uses physical binders, but lots of sites still do. Many of the larger research centers have attempted to streamline their ISF by using generic document collaboration and extranet tools such as Microsoft SharePoint, Box, and DropBox. However, these solutions are not built to support the highly regulated clinical trials market and do not provide proven compliance with FDA Part 11, HIPAA or EMA records retention. None provide purpose-built site-centric workflows, document eSigning, or a comprehensive site regulatory documentation file structure. And, most importantly those records must be FDA audit-ready when the trial is complete, a milestone that is very difficult to meet with generic document storage tools.
SureClinical just announced SureISF to assist its customers’ sites with compliant, streamlined record keeping. SureISF is based on and is inter-operable with SureETMF, its flagship cloud eTMF management solution.
SureISF is easy to use and supports all popular Microsoft Office file formats. It provides trusted Adobe Digital Certificate eSigning and connectivity to popular cloud applications. With its HIPAA-compliant DICOM medical image support SureISF and SureETMF provide clinical trial stakeholders with a value unavailable in any other ISF solution.
Monitors and auditors can review SureISF archives remotely so they can use their time on site more productively, saving sponsors extra travel costs. With connectivity to the eTMF, reconciliation of the site ISF can be done in minutes rather than days. The ISF will be complete, contemporaneous and audit ready. Trusted digital signing ensures the ISF documents will be crisp and clear.
Hard not to see a win for everyone involve in adopting an inter-operable eISF. In a recently published Applied Clinical Trials case study, benefits to quality, time savings, cost savings, and even the environment were discussed. Best of all, clinical investigator sites win as they stay compliant, save time, space and capacity to focus more on the reason they do what they do – work with patients and promote critical research.
If you want to do your own back of the napkin calculation on the environmental impact of going paperless in your clinical trial, try plugging your own numbers in to https://c.environmentalpaper.org/