Comments submitted regarding FDA & OHRP joint draft guidance Minutes of Institutional Review Board (IRB) Meetings: Guidance for Institutions and IRBs. (Docket number: FDA-2015-D-3638). Click here to read the comments and impact on ACRP Members.
FOR IMMEDIATE RELEASE: February 2, 2016 CONTACT: Jeremy Glunt + 1.703.258.3506 firstname.lastname@example.org Research Professionals and the Public to Honor Study Volunteers Who Give the Gift of Participation in Clinical Research Washington, DC and Boston, MA – The Association of Clinical Research Professionals (ACRP) and the Center for Information and Study on Clinical Research Participation (CISCRP), two independent non-profit […]
Carla G. Perna, BS, CCRP, recently reflected on her career and lessons learned as she advanced from research assistant to program director, and on the importance of staying on your toes. Q: What advice do you have for clinical research professionals on how to advance their careers? A: Get your degree; get certified! Pick a […]
Standard operating procedures (SOPs) are the foundation for any effective clinical research program, experts agree. The U.S. Food and Drug Administration (FDA) agrees, too. It’s one of the most common areas the agency scrutinizes during an inspection. Officially, SOPs are defined by the International Conference on Harmonization (ICH) in its Good Clinical Practice Guidelines (ICH […]
In the wake of the full sequencing of the human genome, great promise has been stirred around the prospect of “personalized” or “precision” medicine. This term denotes a collection of techniques that combine various “omics” data—genomics, proteomics, metabolomics, and the like—in order to produce situation-based treatment recommendations that are maximally effective and minimally harmful, because […]