Barnett: Are You a QUALIFIED Clinical Research Professional?

SPECIAL ADVERTISING SUPPLEMENT The term qualified is the guiding standard for a clinical research professional’s work assignments.1 Webster’s dictionary defines “qualified” as “being ‘competent’ to perform the assigned work, duty, function, or task.” Given our healthcare industry roots, competency-based training for clinical research professionals is based on the model used to train healthcare professionals (e.g., doctors, nurses). A […]

The ABCs of IRBs and AMCs

Clinical Researcher—April 2018 (Volume 32, Issue 4) MANAGING EDITOR’S MESSAGE Gary W. Cramer [DOI: 10.14524/CR-18-4024]   If letters are the building blocks of the alphabet, then acronyms are surely the building blocks of clinical research. Where would we be without our CRCs, CRAs, and PIs dealing with CROs and handling EDC as they work on […]

Central IRB vs. Institutional IRB—Advantages and Disadvantages for Multicenter Trials

Clinical Researcher—April 2018 (Volume 32, Issue 4) PEER REVIEWED Pranali M. Wandile, MS, CCRP [DOI: 10.14524/CR-17-0009]   U.S. Food and Drug Administration (FDA) guidance documents, particularly the cooperative research guidance given in 21 CFR 56.114 of the Code of Federal Regulations, only provide suggestions and recommendations. These recommendations do not have legal force. Still, the […]

Bringing the Team Together

Clinical Researcher—April 2018 (Volume 32, Issue 4) EXECUTIVE DIRECTOR’S MESSAGE Jim Kremidas [DOI: 10.14524/CR-18-4025]   With our ACRP 2018 annual meeting just 10 days away (as of the posting of this issue of Clinical Researcher), it’s an appropriate time to reflect on how we can all work together toward our common goal: providing the highest […]

Pam Weppler, MA, PMP, CSSBB, Rho

When Big Change is Coming, the Little Things Matter

Who knew that tiny sticky notes could have such a large impact on a change management program? Pam Weppler, MA, PMP, CSSBB, a process and change program leader, and Ryan Bailey, MA, a senior clinical researcher, learned the power of the Post-it several years ago while leading a massive clinical trial program consolidation at Rho, […]