An examination of the efficiency of some quality assurance methods commonly employed in clinical trials

Stat Med. Jan-Feb 1990;9(1-2):115-23; discussion 124. doi: 10.1002/sim.4780090118.

Abstract

The cost and efficiency of training clinical centre staff and of duplicate data entry in clinical trials is reviewed. Training is an essential component of quality assurance programmes and it is usually carried out at regular intervals in long-term clinical trials. Initial training of staff and regular retraining is important to assure standardization and it can lead to reduced trial costs. Interim training for new staff and for remedial purposes is less efficient than regularly scheduled training sessions. Regional centres for training and the use of computer aided instruction are two ways such interim training can be made more efficient and standardized. Duplicate data entry or verification can result in a substantial reduction in data entry errors depending on the nature of the data being keyed. Selective verification should especially be considered for important fields for which consistency checks cannot be performed, that are alphabetic or that are several characters in length. Quality assurance procedures should be implemented to monitor data entry accuracy in clinical trials.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Documentation / standards
  • Inservice Training
  • Quality Control / methods*
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / standards
  • Research Personnel / education