Clinical project managers, monitors and assistants in the pharmaceutical industry involved in conducting clinical trials are
experiencing increasing regulation. This seems to be more of a hindrance than a help in their daily work. As well as being
expected to be aware of the manifold legal requirements and international regulations such as the German Drug Law (AMG), GCP
Regulation, ICH GCP, various European directives, and FDA guidelines to boot, in the case of global trials, employees are
also confronted with an array of sponsor-generated quality management documents which frequently seem to consist of a tangled
web of rules and regulations. The result is employee dissatisfaction and demands for improvement of the content, a reduction
in the number of SOPs, and improvement in the way the content is presented. This situation is due in no small measure to the
fact that there has been little or no debate to date on what constitutes "adequate quality" of an SOP system.
The literature has comparatively little to say about what an optimal SOP system can and should look like. Most authors limit
themselves to very basic suggestions (e.g., short, meaningful sentences, clarity, use of illustrations)1 or alternatively very detailed instructions,2 which are ignoring basic elements of instructional design. GCP requires "the setting up and maintenance of quality control
systems supported by written SOPs,3 but provides virtually no guidance on SOP system design.
Only a few articles looked into the complex regulatory environment of the pharmaceutical industry4 and the resulting principles of writing effective SOPs.5, 6
SOP benchmarking project
The German Association of Research-Based Pharmaceutical Manufacturers—Verband Forschender Arzneimit-telhersteller (VFA)—appointed
a taskforce from the Clinical Research and Quality Assurance subcommittee to look into the topic. The VFA is an organization
of 45 research-based pharmaceutical companies whose studies, between them, make up a significant portion of clinical trial
activity in Germany. Responses in this survey were obtained from several companies who belong to the leading pharmaceutical
companies in Europe. The aim of the SOP Benchmarking project was to evaluate existing SOP systems on the basis of existing
best practices and benchmarking, and to develop proposals for potential improvements. Existing SOP systems including the associated
training were to be analyzed and improvement proposals were to be designed as appropriate on that basis. Another important
issue was to determine whether specific SOP concepts were associated with higher "satisfaction" on the part of the parties
concerned in their respective functions. The survey was conducted in late autumn of 2009 to determine the current state of
affairs among VFA member companies, identify the mood/opinion of their employees with respect to the current situation, and
present proposals as to what sponsors could do to change their SOP systems or remedy any deficiencies and inadequacies.
The questions related only to SOP systems used to conduct Phase I to Phase IV clinical trials and did not cover health outcome
studies or non-interventional studies.