The International Council for Harmonization (ICH) E6 Guideline for Good Clinical Practice (GCP) dates back to 1996, when clinical trials were largely managed with paper documents. Since then, the scale and complexity of clinical trials have greatly increased. This has given rise to the need to revise ICH E6 to better reflect advances in technology, […]
The perspectives offered in this opinion piece come from the author, who works in a contract research organization (CRO) with a site alliance; from two investigators and a study manager who conduct clinical research; and from personnel at a CRO-like organization with a new hybrid approach that offers staff and processes to help investigators conduct […]
Beth Harper, president of Clinical Performance Partners, Inc., a clinical research firm, has worked to enhance patient recruitment and retention and improve sponsor and site relationships for more than 30 years. Last month, the Association of Clinical Research Professionals (ACRP) named Harper its new Workforce Innovation Officer. She will spearhead ACRP’s initiatives to lead innovation […]
Electronic data capture (EDC), central monitoring, and risk-based monitoring (RBM) have been disruptive to the entire clinical research enterprise. These new technologies and processes offer the potential to increase efficiency while reducing onsite monitoring and data management costs. Sponsors and contract research organizations (CROs) are crafting standard operating procedures (SOPs) which will allow these changes […]
Improve your consent process by learning how to assess a participant’s reading level, health literacy, and overall understanding of clinical trial participation and address culture, learning styles, emotional states and language. This eLearning course will provide essential tools for those directly involved in informed consent discussions.