In order to diminish inter-observer variability and ensure uniform and high standard practice, all clinical and laboratory procedures have been optimized and standardized. Towards this, a number of manuals detailing study protocols and inclusion criteria for phenotypic characterisation of the cohort have been formulated. Further, R4RA administrative staff are happy to arrange training for all procedures.

  • R4RA Clinical characterisation: A R4RA Clinical Protocol, R4RA Recruitment Protocol, R4RA Follow Up Visit Protocol together with an Ultrasound Manual and Treatment Algorithms have been drawn and are provided to and, used by all the participating R4RA centres. Additionally, further ultrasound training at is provided in order to standardise image acquisition techniques and review the OMERACT definitions of ultrasound pathology, including synovitis and erosion.

  • R4RA Database Manual has been constructed and disseminated to all the participating R4RA centres. This manual details online access to the R4RA Bio-bank and tracking of the samples provided to R4RA (this function is to be released in Spring 2015).

  • R4RA sample collection manual/SOP and R4RA Sampling Kits containing all the materials required for collection, labelling and transport of the R4RA samples, have been generated and supplied to all R4RA participating sites. The R4RA Sample Collection Manual/SOP contains full details and instructions for sample collection, packaging and transport. In this context, DHL has been contracted for sample transport in order to ensure safe and efficient transport of samples.

The R4-RA trial is funded by the MRC-NIHR Efficacy and
Mechanism Evaluation Programme