What’s Important for Compliance? Compliance Requirements Focus Group Results

In January, the eRA Requirements Team held a focus group geared solely towards compliance.  Twelve compliance professionals from NC State participated in the session. This included: eight members of Central Research Administration, two Environmental Health and Safety personnel, and two individuals from Security and Compliance. The focus of this session was to get input from compliance stakeholders on what a new electronic research administration (eRA) system should do to insure and document compliance throughout the sponsored program lifecycle (proposal, award, closeout). This step is critical for our new system, because the entire award lifecycle is encircled by compliance.

 Attendees participated in a large group discussions about what they need the system to do as well as what the system could do to support compliance at NC State. After two discussions, relating pre- and post-award processes to compliance, many requirements for the system were identified. The Word Cloud to the right highlights some of the common themes that were discussed.

Upon further consideration of the extensive list of compliance requirements, the following requirements were identified as the summarized compliance requirements for the eRA system.

1. Workflows and hard stops. Customization of workflows, access and approvals based on identified variables; including hard stops and clear warning indicators for user actions.
2. Notifications. The system should provide automatic and customized notifications to all end users.
3. Record management. A mechanism should be provided for special record retention/destruction (e.g. a national security directive to eliminate all traces of a proposal, an investigative hold preventing normal destruction).
4. Reporting and data requirements. Generate reports and/or submit data electronically as required by regulatory reporting requirements and produce these reports/data in required format. Data fields should be customized and integrate with University and third party applications and data sets.
5. Risk assessments. These should be supported per Uniform Guidance requirements.
6. Compliance triggers. Trigger relevant compliance verification processes (COI, IRB, IACUC, IBC, Required Training,Safety Plans, etc.) as part of proposal preparation. Provide easy navigation to compliance forms/modules/systems through links, etc.
7. System Integration. The system should interface with compliance modules/systems (COI, IRB, IACUC, IBC, Required Training,Safety Plans, etc.) to easily access relevant related protocol information.
8. IRB processes. These processes should be tailored to behavioral trials rather than medical trials.

While the vendor solutions may not be able to give us everything we want, the process of collecting these requirements from each group is extremely important for the development of the RFP that will be sent out. Our new eRA system should help us to improve our compliance efforts.

We would love you hear your thoughts; use the commenting tool below to share them!