The ICH GCP Guideline integrated Addendum provides a unified standard to facilitate the mutual acceptance of clinical data by regulatory authorities in the European Union, Japan, the United States, Canada and Switzerland.
The ICH GCP E6 guideline was adopted in 1996, and clinical trials have evolved substantially in the past 21 years. The (E2) addendum aims to improved three key areas are the European Medicines Agency (EMA) performed GCP audits and found inadequate quality control and a decrease in sponsor oversight:
- Data Management
- Source Documentation
There have been significant changes that affect the Sponsor making them ultimately responsible for data quality. Implementing a Functional Service Provision outsourcing model can help Sponsors keep track of important changes and employ experts in these fields.
Some important changes include:
- Implementing a risk-based approach to the Quality Management System to identify critical risks in systems and clinical trials and evaluate those risks
- Documenting approval of any subcontracting of trial-related duties and functions by a CRO
- Developing a systematic, prioritized, risk-based approach to monitoring clinical trials by developing a monitoring plan that is tailored to the specific human subject protection and data integrity risks of the trial
- Ensuring the Investigator has control of and continuous access to the CRF data reported
How can an FSP model be applied to your Risk-Based Approach?
One of the key aspects of the new addendum is that Sponsors are responsible for the oversight of clinical trials and the CROs they choose.
FSP provides a scalable team of resources to meet immediate or long-term resourcing needs through on-site or remote full time employees. The key component of an FSP model is relying on expert resources. Sponsors can look to employ resources by their expertise in subject matter and/or therapeutic area as well as their geographic area.
When looking to implement a risk-based approach to a clinical trial, Sponsors may be in need of the following experts:
- Biostatisticians to evaluate data from sites
- Clinical Data Managers with specific EDC system knowledge
- Project Managers
- Quality Assurance Managers
In an FSP approach, the Sponsor can rely on the CRO to take on the Human Resources function and provide coverage in case of absences and determine cultural fit within the company. This helps companies reduce risks related to their resources throughout a project.
More importantly, in an FSP approach, the CRO is responsible for team integration and training on technology, SOPs and processes.
The CRO would provide an FSP Project Manager and implement a Communications Plan so the Sponsor can have full oversight on the project.
Example of FSP applied to a Risk-Based Approach – Risk Management Metrics
Risk Management Metrics (RMM) is a solution for Risk-Based Monitoring in which data managers monitor study data taking into account risk factors and categories in order to track study progression and solve critical situations.
RMM is a suite of threshold reports within EDC technology platforms that Data Managers use to produce real-time information of study progress.
If Sponsors are looking to implement a risk-based approach to monitoring and data management, an FSP solution of taking on a team of data management resources could be a suitable approach. In this case, the CRO would guarantee a selection of data managers that meet the Sponsor’s geographic requirements and culture fit requirements (such as preferred language) as well as provide profiles that match the level of expertise needed – e.g. junior or senior level, EDC system experience, therapeutic area.
Data Managers would then prepare a Risk Management Metrics Plan and help the Sponsor identify metrics that need to be determined using the specified EDC system. The Data Manager reviews the data and track outcomes sharing the tracker with the rest of the study team. Standard and ad hoc reports are created based on Sponsor needs allowing for fast and easy metrics programming. To ensure maximum oversight, the Sponsor can also access the metrics via personal log-in credentials.
CROS NT has a 5-point FSP model based on Sustainable Quality. To learn more about how an FSP model can be applied to a risk-based approach, contact us.