Research challenge | Solution(s) or idea(s) |
---|---|
Regulatory requirements | • Involve legal, contracts, and procurements staff early in the process • Be prepared to adjust system architecture and computing center environmental specifications • Take advantage of U.S. funder (NIH) policies such as single IRB and Certificates of Confidentiality • Adjust quality control processes and procedures for monitoring, reporting, and auditing • Be prepared to limit data storage to select partners and data warehouses per DUAs • Negotiate onerous terms and conditions that do not adhere to study design and Prime contractual requirements |
Protocol complexities | • Create an IMS that ∘ Is data-driven ∘ Is web-based ∘ Enables adaptive sampling ∘ Uses multiple linking identification schemas ∘ Uses an agile approach that ensures participants and staff find the IMS user-friendly ∘ Allows tailored event, incentive, reporting, and delivery routines and functionality ∘ Is scalable and flexible enough to accommodate protocol modifications ∘ Adheres to security, privacy, and compliance requirements |
Multiple technology partners and/or platforms | • Plan for differential DUAs and accompanying limitations and understand the implications for the protocol and architecture (e.g., monitoring, security reviews, level of access) • Negotiate system boundaries by partner and platform; adjust if (and level of) system interconnections necessary to accomplish re linkage and data capture, status reporting, and delivery • Budget appropriately to account for software, platform, and technological enhancements (e.g., new versions, downtimes, security changes) and how e-linkages between systems are affected (scalability and flexibility are key constructs) • Ensure specific hardware/sensors, manufacturing and production schedules can achieve main protocol recruitment timelines, sharing/distribution of sensors, and implications on chain of custody and analysis • Plan that participating laboratories often have existing LIMS with unique data linking requirements and may be outdated and separate from laboratory-to-laboratory |