Today, ACRO announced four new data governance resource, co-developed with TransCelerate BioPharma. Created to assist key industry stakeholders in easing challenges associated with operationalizing the requirements of the new ICH E6(R3) guidelines, these adoption tools, frameworks, and templates are designed to support GCP stakeholders with compliance, data quality, and decision-making.
Resources
Data Governance Framework
- Provides background on data governance, a new section within ICH E6(R3), and its utility in clinical research. The framework connects the entire toolkit of ACRO/TransCelerate data governance solutions to help GCP stakeholders develop a data governance framework.
Data Flow Diagram Framework & Template
- Assists companies in developing maps to illustrate relevant data flows between various data collection tools (e.g., EDC, ePRO, eCOA, central labs) and involved stakeholders (e.g., sponsor, CRO, third-party vendors) in a study.
Safeguarding Blind Considerations Tool
- Explains topics necessary to the concept of safeguarding blinding in clinical research. Topics include what blinded data is, why data is blinded, the importance of maintaining blinding, who may be unblinded, and steps to take in case of unblinding.
ICH E6(R3) Technology Framework
- Explains the computerized systems (CS) requirements outlined in ICH E6(R3) and details potential procedures for using computerized systems, training, security, validation, periodic reviews, system failure, technical support, and user management.