Process Management Framework: Guidance to Successful Implementation of Processes in Clinical Development

Abstract

Clearly defined, documented, and managed processes form the foundation for how we effectively develop medicines for our patients. For this reason, process has been identified as a primary "element" of an effective quality management system (QMS) as described in the TransCelerate clinical quality management system (CQMS) conceptual framework. The importance of identifying and effectively managing processes is also emphasized in ICH GCP E6 (R2) in the new Section 5.0 Quality Management. An effective process management framework is fundamental to ensure the efficient and effective delivery of clinical development programs, enhance quality and productivity, and ultimately benefit our ability to deliver needed treatments to patients. The aim of this paper is to provide a conceptual process management framework to be used as guidance for effective process mapping, process documentation, implementation of optimal learning methods, and ensuring ongoing process performance evaluation and continuous improvement.

Quality Assessment of the Clinical Practice Guidelines of Ostomy Care Based on the AGREE II Instrument

“…Applicability is the key factor in the successful implementation of guidelines in clinical practice ( 22 ). The appraisal CPGs received the lowest scores in the applicability domain, indicating that the guideline developers did not pay sufficient attention to the potential barriers affecting the practical implementation of the recommendations, such as costs and hospital resources ( 23 ). To better facilitate the application of the guidelines, effective strategies such as guideline abstracts, flow charts, evaluation forms and other relevant resources could make it easier for the guidelines to be applied and implemented.…”