Clinical Sites

EVICR.net»SOPs

Clinical Sites SOPs

EVICR.net has developed a Quality System for its members which is based on the ICH-GCP Guidelines. All our Clinical Sites Members agree to adopt and implement Standard Operating Procedures (SOPs) in their Centres that will be checked before they are certified as Sites of Excellence.

These 6 SOPs are:

  • SOP ECR 500 – Template for Clinical Sites: Preparation, Approval, Distribution, Revision and Withdrawal of SOPs (Master SOP)
  • SOP ECR 501 – Human Resources Management: Staff Responsibilities, Functions and Training
  • SOP ECR 510 – Pre-Study Activities
  • SOP ECR 511 – In-Study Activities
  • SOP ECR 512 – End-of-Study Activities
  • SOP ECR 530 – Infrastructures Management

The implementation of these 6 organisational SOPs will permit the Clinical Sites to have a standard way of working and in compliance with ICH-GCP Guidelines when performing clinical research. Since they are common to all members it is a platform to perform Investigator Initiated Research (IIR) or Industry-Driven Studies within the Network.

Technical SOPs

EVICR.net has also developed Technical SOPs which are a valuable tool to perform clinical trials. These are written SOPs for performing specific ophthalmic examinations or evaluations that can be used within the Network for Investigator Initiated Research or Industry-Driven Clinical Trials.

Retina SOPs

  • SOP ECS 1101 – Fundus Autofluorescence
  • SOP ECR 1103 – Refraction and Visual Acuity Measurements at 4 meters
  • SOP ECS 1104 – Ocular Angiography
  • SOP ECS 1108 – Visual Field Examination

Retina and Glaucoma SOPs

  • SOP ECR 1102 – Stratus Optical Coherence Tomography
  • SOP ECS 1105 – Color Fundus Photography
  • SOP ECR 1109 – Spectralis Domain Optical Coherence Tomography (Spectralis and Cirrus OCT)

Glaucoma SOPs

  • SOP ECS 1201 – HRT – II/III, Imaging
  • SOP ECS 1202 – GDx VCC
  • SOP ECS 1203 – FDT – Frequency Doubling Technology
  • SOP ECR 1204 – 24-Hour IOP Curve and Tonometry
  • SOP ECS 1205 – Visual Field Examination

Anterior Segment SOPs

  • SOP ECS 1301- Intraocular Pressure
  • SOP ECS 1302 – Refraction
  • SOP ECS 1303 – Contrast Sensitivity
  • SOP ECS 1304 – Pachymetry
  • SOP ECS 1305 – Pupilometry
  • SOP ECS 1306 – Corneal Topography
  • SOP ECR 1307 – Visual Acuity
  • SOP ECR 1308 – Straylight Measurement
  • SOP ECR 1311 – Ocular Aberrometry

Ocular Surface, Inflammation, Dry-Eye & Allergies SOPs

  • SOP ECR 1401 – Impression Citology
  • SOP ECR 1402 – In Vivo Confocal Microscopy Examination
  • SOP ECS 1403 – Conjunctival Biopsy
  • SOP ECS 1404 – Aesthesiometry
  • SOP ECS 1405 – Schirmer Testing
  • SOP ECS 1406 – Tear film break up time (TFBUT)
  • SOP ECS 1407 – Ocular surface staining grading
  • SOP ECS 1408 – Standardized sequence of events
  • SOP ECR 1409 – How to define Meibomian Glad Disease