Community Spotlight

GCP-QA Community Creates Tools for ICH E6(R2) for Small- to Medium-Sized Companies

Sandy Mohan
Quality and Compliance
Immune Design
Terry Katz
Global Data Management and Statistics
Merck Animal Health

IA’s GCP-QA Community was actively involved in 2018 and 2019 to create tools to support the 2016 revision of ICH E6(R2), the global standard for Good Clinical Practices (GCP) issued by the International Council for Harmonisation (ICH). This Community project followed a previous cross-community DIA Working Group sponsored by the Good Clinical Practices and Quality Assurance (GCP-QA) Community in 2014 and 2015 to solicit comments and concepts from sponsors and CROs for the ICH E6 revision submitted through the European Medicines Agency (EMA).

The updated ICH GCP guideline now states that Quality Management “throughout all stages of the trial process” has become a formal responsibility of sponsors. Many large pharmaceutical companies had adopted tools from TransCelerate to document their compliance. But these tools were fairly elaborate, so developing tools right-sized for use by small- to medium-sized organizations became the goal of the GCP-QA Community project.

Global Team

Sandy Mohan and Maryrose Petrizzo, both members of the GCP-QA Core Committee, raised the topic to the GCP-QA Chair, Terry Katz, who issued a broadcast for volunteers from the Community. The response was very high, with seven members of the global GCP community joining the initiative. Multiple workstreams with biweekly meetings were started to evaluate existing quality risk management tools, and either modify or replace them with tools geared towards small- to medium-sized companies. The full team agreed that the ultimate deliverable to the Community would be to publish an article in DIA’s peer-reviewed Journal Therapeutic Innovation and Regulatory Science (TIRS) as a place to reference the quality risk management tools.

The team initially decided that the set of tools should consist of a Plan, an SOP, and a risk assessment spreadsheet. The team wanted these tools to be simple enough for small companies to easily adapt and adopt. Accordingly, the team agreed to draft templates for a Risk Management SOP, a Risk Management Plan, and a Risk Log (Excel spreadsheet) that captures risk assessment. Other members of the team emphasized the importance of vendor oversight, and the team agreed to additionally draft templates for a Vendor Oversight Plan and a Vendor Oversight SOP.

After many rounds of review, several members of the team submitted proposals to present the Risk Log (risk assessment spreadsheet) in the Engage and Exchange session at the DIA 2018 Global Annual Meeting in Boston. The team met several times during Q1 and Q2 of 2018 to finalize the drafts in order to present at the Engage and Exchange session. The actual session was well attended, and the response was very strong, especially from representatives of smaller companies.

Feedback from the public workshop was incorporated into the final tools. This led to the drafting of a formal manuscript for TIRS, which was accepted for publication in August 2019. The major content includes SOP templates for clinical risk management (as a framework for risk identification, classification, monitoring, and mitigation throughout the lifecycle of a clinical trial) and vendor oversight (to describe the process for [re]qualification, selection, contracting, and oversight). Templates for a study-level Clinical Risk Management Plan and Vendor Oversight Plan to implement the actions from the SOPs are provided, as is the Clinical Risk Log spreadsheet to identify potential risks, define the primary response strategy, and calculate the Risk Priority Number (RPN). Online additives to the article include the Excel Spreadsheet Tool that generates the Clinical Risk Log. The article is now available online, discoverable, and fully citable on PubMed.