The questions that arise in the practice of clinical research can hardly be
answered by reading the guidelines, guidances or directives. These
documents will give a general answer to an often non-existing problem. A
lot of questions are more complex and comprise of several elements. Profess
has been involved in clinical research as of 1977 in both field functions
like study monitor, study manager and international medical projectleader
for a cardiovascular compound, and management functions like medical
director and director of regulatory affairs and technical research. During
those years we have learned to identify problems, analyze the problems and
brainstorm on the best solution possible taking into account the regulatory
requirements, scientific validity, ethical and professional conduct and
above all, plain common sense.
A database with numerous GCP oriented questions and answers exist, but
every question is often unique and needs a personal touch from a renowned
expert.
