Consideration of study protocols by CRD

CRD is often asked to comment on draft study protocols in order to confirm that the design and methodology is appropriate and will potentially address a specific data gap. This is particularly the case for more complex higher tier studies for which some novel method or approach is necessary that is not covered by existing guidance. For example, applicants may wish CRD to assess the study design for a mesocosm study to address a compound of known environmental concern, or a biomonitoring study for operators using some novel method of application.
Previously such advice has been provided via CRD’s ‘Applicant Enquiries Team’ and charged to the levy for all approval holders. However, in light of the work involved in assessing such requests, and the detailed discussion that often takes place between CRD specialists and the applicant, it is considered appropriate to recover the costs associated with this work through the charging of a fee proportionate to the work involved. With immediate effect such requests will be considered via submission of an application.