Patient Recruitment

Patient Recruitment and Study Design Factors that may affect patient recruitment and retention should be considered during study design. This includes eligibility/ineligibility criteria, procedural burden, endpoints, number of study visits and trial duration. Learn...

Biospecimen Procurement, Collection, and Management

BioMe® BioBank Program What The BioMe® BioBank Program is an electronic medical record-linked biobank that enables researchers to conduct genetic, epidemiologic, molecular, and genomic studies on large collections of research specimens linked with medical information....

Data Management

Data and Safety Monitoring What The IRB ensures that every research protocol has an adequate monitoring plan in place to assure the safety of research subjects [45 CFR 46.111(a)(6) and 21 CFR 56.111(a)(6)]. The type and degree of monitoring required is related to the...

Subject Matter Expert Guidance

Subject Matter Expert (SME) Guidance Collaboration or consultations with subject matter experts can optimize clinical protocol development. Below is a list of SMEs to consider consulting with when designing a protocol. BioMedical Engineering and Imaging Institute...