Good Evaluation Practice: a proposal of guidelines.
The intention of this proposal is to describe principles for Good Evaluation Practice (GEP) of toxicological and risk evaluations with the aim to improve the quality, reliability, and transparency of any evaluation in toxicology. The GEP has been outlined in the same way as the principles for Good Laboratory Practice (GLP) to facilitate its introduction and compliance. The main characteristic of GEP is transparency. The GEP procedure should include the following elements: (1) definition of terms; (2) description of evaluation organization; (3) description of the quality assurance of the programme; (4) description of the standard evaluation procedures; (5) performance of the evaluation; (6) reporting of the evaluation; (7) storage and retention of records and material; and (8) guidelines for the evaluation procedure. The authors' intent is to raise awareness, stimulate a debate about the proposal, expect and welcome feedback in order to refine it, and make it into an important tool for all toxicological evaluations in the future.
Malmfors
Torbjörn
T
Malmfors Consulting AB, Karlskronavägen 22, S-121 52 Johanneshov, Vastmannagatan 48, 11325 Stockholm, Sweden. malmfors.consulting@mbox.tninet.se
Di Marco
Peter
P
Savolainen
Kai
K
D005069:Evaluation Studies as Topic; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D011786:Quality Control; D018570:Risk Assessment / Q000379:methods / Q000592:standards*; D018675:Toxicity Tests / Q000379:methods / Q000592:standards*