Human stem cell research includes research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, human umbilical cord stem cells, and human adult stem cells. Stem cell research is typically overseen by a Research Committee who is responsible for developing research guidelines on issues such as transplantation of human cells into animals, derivation of new lines, donors, and registries; as well as reviewing and approving research protocols.

All researchers conducting Stem Cell research must submit a protocol to a Research Committee. To assure that research involving the use of human stem cells is in compliance with regulations and compliance standards at your research organization, Key Solutions offers a web-based Integrated Research Administration and Compliance module for Stem Cell Research.

Our module helps organizations manage the protocol compliance process as well as the proper documentation of facilities, capital equipment, materials, and data in facilities where both research supported by federal funds is conducted and where non-registered hESC research is conducted.

Key Highlights:

• Online submission, including an automatic check for completeness
• Controlled and secure user access
• Access to review status, as well as reviewer comments and feedback
• Side-by-side changes displayed for version control
• Email notification of comments requiring action steps
• Email messaging between investigator, IRB and reviewers
• Ability to set up meetings with panel members and record minutes
• Ability to generate reports in PDF, HTML or Excel format
• Encrypted signatures for use with Approval Letters and other documents