Rationale
Historically, there have been challenges addressing ambiguous regulations/guidances and Health Authority operational expectations. Specific challenges have included one or more of the following elements:
- Substantive ambiguities in text of regulation/guidance, which may result in, among other things, challenges in interpreting regulations/guidances
- Divergence in regulatory requirements and expectations across global Health Authorities
- Real world impediments to operationalizing Health Authority expectations
TransCelerate ICH E6(R3) Solutions for Public Comment
ICH E6(R3), the latest revision of the International Council for Harmonisation’s Good Clinical Practice (GCP) guidelines, introduces critical enhancements to ensure the quality, reliability, and ethical conduct of clinical trials. Among these updates, a dedicated section on data governance has been introduced.
To aid industry in the understanding of this new section, TransCelerate and ACRO have developed a draft tool, Data Life Cycle Framework, to walk stakeholders through data life cycle elements in clinical trials, in accordance with the ICH E6(R3) Annex I, Section 4.2. This tool provides considerations that may help support better understanding of how data is moved and used during a clinical trial, as well to facilitate accurate reporting, verification, and interpretation of clinical trial data, which is critical to support reliability of trial results and the protection of participants.
TransCelerate also has developed a draft trial start-up tool focused on providing general considerations for early trial design through the integration of a critical thinking mindset, quality by design, knowledge management, and operational feasibility principles.
As we strive for greater transparency, TransCelerate and ACRO would like to invite the public to provide their perspectives and input on these tools during a 1-month public comment period.
Stakeholder feedback is critical to help ensure these deliverables address the differing needs of their intended audience, which includes sites, CROs, sponsors, academics, and clinical trial vendors. Please consider providing feedback by using the links below.
For additional information, please see the links below:
- Data Life Cycle Framework (under development) (Co-developed with ACRO)
- Trial Start-up Tool (under development)
- Public Feedback Form
For a full view of finalized TransCelerate ICH E6(R3) tools and solutions, check out our ICH E6 Asset Library.
Benefits
Addressing these challenges will bring value to patients, sponsors and regulators. Examples of this value include:
- Patients: Enhanced patient outcomes/safety through a better understanding and exploration of operational best practices to meet ambiguous regulations/guidances.
- Regulators: Clarification of ambiguous regulations/guidances through proactive sharing of feedback, observations, consequences, and proposed best practices with Health Authorities.
- Sponsors: Reduced compliance risks through better understanding of regulations/guidances. Increased effectiveness and efficiencies in meeting the operational expectations of ambiguous regulations/guidances.
