Site impact of new ICH/GCP guidelines
The industry largely accepts ICH/GCP guidelines as the gold standard regarding conduct in clinical research, which was recently updated in response to the increasing use of technology as well as findings from regulatory inspections. In November 2016, the second revision to ICH Good Clinical Practices E6 R2 contained an integration of 26 new additions to serve as guidance for clinical study conduct.
A large portion of the addendum relates to sponsor conduct; however, there are considerable implications for sites, particularly in areas that are common findings from regulatory inspections. Some areas that relate to investigator conduct include standard operating procedures (SOPs), document storage, record keeping and delegation of authority. Sponsors look to work with sites that act in accordance with ICH/GCP guidelines, and it is critical that appropriate steps be taken to ensure compliance.
Ensuring quality has always been a principle of GCP. In the addendum, there is additional emphasis on “aspects of the trial that are essential to ensure human protection and reliability of trial results.” In order to maintain quality, sites can implement systems related to the informed consent process, SAE reporting, source documentation, etc. All systems should be clearly documented in SOPs or guidance documents. Many sponsors require sites to have these put in place during the feasibility phase.
Safeguarding documents and keeping a record of where they are located is essential for investigators to maintain throughout each clinical study. For many sites, medical records can be stored in multiple locations and be a combination of paper or electronic formats. This addition will involve assembling a locations list of all essential and source documents that relate to a trial. Also included in this section (8.1), the sponsor is required to ensure the investigator has continuous access to the CRF data. Including this process is a helpful addition to a site’s SOP collection.
In addition to the storage of documents, the quality of data is of equal importance. The investigator is tasked with maintaining adequate and accurate source documents and trial records. Source data should be “attributable, legible, contemporaneous, original, accurate and complete” (Guideline for Good Clinical Practice E6(R2) 4.9). Sites can align with this requirement by making sure any changes to source data are documented clearly. Crossing items out or using white ink are not compliant with this addendum; it is essential to leave an audit trail.
Two new items were added by ICH regarding the delegation of authority and training. The investigator is held responsible for any individual or group whom he or she delegates study-related tasks that are conducted on site. This includes making sure functions are delegated to an individual or party that has been vetted by the investigator to ensure qualifications are met. Beyond ensuring training and delegation, Investigators must continue to supervise any party conducted trial-related tasks and documenting all oversight. It may be helpful for sites to keep all correspondence between the investigator and study staff, as well as meeting minutes, phone calls, etc.
Many of these additional guidelines allow for more flexibility with trial design, in hopes of increasing clinical trial efficiency. This addendum is expected to increase adoption of different strategies, such as risk-based and centralized monitoring, and has adjusted some terminology to be more inclusive of multiple media types. Specifically, “evolutions in technology and risk management processes” are stated as reasoning behind the new additions. It will be interesting to witness the evolution of the clinical research industry as sponsors and CROs adapt to these new guidelines and develop new strategies for conducting clinical trials.
Sites can continue to tweak and improve current processes or procedures put in place. Taking the steps necessary to ensure GCP compliance will not only make sites more attractive to sponsors and CROs, but it will also include measures that allow the site to operate at increased efficiency. It is never a bad time to take a step back and address areas for improvement.
Dr. Christophe Berthoux has been the chief executive officer at Synexus since September 2010. Synexus is the world’s leading site management organization (SMO), dedicated to the recruitment and management of clinical trials across the globe for over 24 years. Synexus is proud to be the patient’s choice for clinical research. Email comments and questions to email@example.com.
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