Ethics Committees & IRBs
Regulatory Authorities
Medical Ethics Review Committees or IRBs play a crucial role in the approval and oversight of clinical research to ensure the safety and rights of participating parties. ResearchManager has provided specialized and proven tools and solutions for years to support Ethics Committees in the assessment and management of clinical research, enabling them to effectively carry out their important mission.
Efficient Review and Approval of Protocols with RIMS
ResearchManager RIMS (Regulatory Information Management System) provides Ethics Committees with an advanced tool for the efficient review and approval of research protocols and related documents. With RIMS, committees can centrally store, manage, and share documents, creating a standardized and transparent workflow for protocol review and compliance. Additionally, RIMS features include tracking approval processes and generating reports, simplifying regulatory compliance and enhancing the efficiency of Ethics Committees.
Swift Approval through Digital Signatures (eSign)
With RIMS, Ethics Committees or IRBs can leverage digital signatures (eSign) for the secure and rapid approval and management of documents. This enables committees to expedite the review and approval of documents, resulting in significant time savings and an enhanced research process. Ideal for all parties involved, it is essential for fostering seamless collaboration among various departments and stakeholders.
Data Security and Compliance with Laws and Regulations
RIMS is designed with a focus on compliance with stringent regulations and information security requirements. We ensure adherence to specific standards and ethical guidelines, which is crucial for Ethics Committees. With detailed audit trails, access control, and digital signatures, RIMS provides a solid foundation for regulatory compliance and data security. This allows committees to have confidence in full compliance with all legal requirements throughout the entire process.
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Saskia van Gastel
Accountmanager