Usage and usability of standard operating procedures (SOPs) among the coordination centers for clinical trials (KKS).
OBJECTIVE
With Standard Operating Procedures (SOPs) the conduction of clinical trials should be standardized so that the results are comparable and traceable. This aim can only be reached if the staff of clinical trials really uses the SOPs. Therefore, we conducted a survey to explore the use and usability of SOPs in clinical trials and to identify problems for their handling.


METHODS
Standardized, validated questionnaire among the staff of all 12 coordination centers for clinical trials in Germany (n = 238), anonymous, descriptive analyses


RESULTS
A return rate of 58.8% was reached. When having questions about the daily work 18.4% more likely ask a colleague than read the corresponding SOP (13.8%). For the relevance of SOPs 16.9% of the staff regard less than 10% of SOPs as relevant for them. Exclusively working with electronic SOPs are 4%.


CONCLUSIONS
The results of the survey indicate that improvements for the handling of SOPs are necessary. They could be used to design a computer-based information retrieval system for SOPs to increase the ease-of-use and usefulness of SOPs in clinical trials.
Krockenberger
K
K
University of Heidelberg, Coordination Center for Clinical Trials, Heidelberg, Heidelberg, Germany. katja.krockenberger@med.uni-heidelberg.de
Luntz
S P
SP
Knaup
P
P
D022126:Access to Information; D035843:Biomedical Research / Q000458:organization & administration* / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection; D005858:Germany; D006801:Humans; D008490:Medical Informatics / Q000458:organization & administration* / Q000592:standards; D010865:Pilot Projects; D011795:Surveys and Questionnaires