On June 11, 2015, the International Conference on Harmonization released the draft update of Good Clinical Practice guidelines. The proposed R2 addendums are a significant update and feature important addendums affecting investigator oversight, document processes, monitoring plans, and validation. (The changes will not be final until November of 2016.). All these pull the tide towards further electronic management of clinical trials.
With R2, investigator oversight responsibilities are increasing.
R2 explicitly makes it the responsibility of the investigator to ensure any changes to source documents are noted and signed with reason for changes. Of note, R2 also requires the sponsor to provide site access to all essential documents before, during, and after the trial. Clearly there will be more focus on clinical trial document management for both the site and sponsor.
A certain transition to digital source
Importantly, R2 makes direct comments on e-source. It supports certified copies with the statement that certified copies of source can be created by the use of dated signatures or via validated processes to produce exact copies as the original. This allows for source documents outside the trial site EHR workflow to be created and maintained in an electronic format.
Inside an Automated Healthcare Practice: Redesigning Care Around People, Not Paperwork
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Standard operating proceeddures (SOPs) give PI’s control
The transition to new processes is truly under control of PIs and their SOP management. We’re glad that R2 provides guidance here, not only for migration to e-source but also regarding software selection. Specifically: “SOPs should cover system setup, installation and use….describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning and decommissioning….responsibilities of … parties with respect to … computerized systems should be clear, and the users should be provided with training”.
What’s it all mean?
The ICH guidance frees up sites to perform more tasks with electronic source, but also mandates reasonable GCP practices for the transition. Without the help of software, PI oversight requirements will increase as a result of this guidance, but if the investigator has a capable source management platform they will be neutral at worst. Now is the time to move beyond three ring binders, scanners and faxes as the tools of choice for source management and embrace software that can help.
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