- Clinical Sites SOPs
The implementation of common organizational Standard Operating Procedures (SOPs) will permit the Clinical Sites to have a standard way of working and in compliance with ICH-GCP Guidelines when performing clinical trials.
- SOP ECS 500 - Template for Clinical Sites: Preparation, Approval, Distribution, Revision
and Withdrawal of SOPs (Master SOP)
- SOP ECS 501 - Organization of Clinical Site (Staff, Responsibilities, Functions, Staff
Training)
- SOP ECS 510 - Pre-Study Activities
- SOP ECS 511 - In-Study Activities
- SOP ECS 512 - End-of-Study Activities
- SOP ECS 520 - Ethical and Regulatory Approval for Clinical Trials and Progress Reporting
to Ethics Committees and Regulatory Authority
- SOP ECS 530 - Equipment (Basic procedures for Maintenance, Calibration, etc.)
- SOP ECS 540 - Subject Safety: Reporting of AE, SAE, SUSAR, Emergency Procedures
These 8 SOPs are provided for free to the member Clinical Sites. The Coordinating Centre helps the Clinical Sites in adopting these template SOPs in order to be certified as Clinical Site of Excellence.
Since they are common to all members it is a platform to perform Investigator Driven Clinical Trials or Industry Driven Clinical Trials within the Network.
- Technical SOPs
Technical SOPs are a tool to perform clinical trials. They are common SOPs in performing specific ophthalmic examinations or evaluations that can be used within the Network for Investigator Driven Clinical Trials or Industry Driven.
The Retina Expert Committee has prioritized to write 8 technical SOPs and from these it has already approved and distributed 5 technical SOPs, duly identified below:
- Retina SOP ECS 1101 - “Fundus Autofluorescence”
- Retina SOP ECS 1102 - “Optical Coherence Tomography”
- Retina SOP ECS 1103 - “Refraction and Visual Acuity Measurements at 4 meters”
- Retina SOP ECS 1104 - “Ocular Angiography”
- Retina SOP ECS 1105 - “Fundus Photography
”
The Glaucoma Expert Committee has prioritized to write 11 technical and has 2 technical SOPs already approved and distributed:
- Glaucoma SOP ECS 1202 - “GDx VCC”
- Glaucoma SOP ECS 1203 - “FDT – Frequency Doubling Technology”
The Cornea, Cataract and Refractive Surgery Expert Committee has decided to write 12 technical SOPs which were selected as the most important. 8 technical SOPs have already been approved and distributed:
- Cornea, Cataract and Refractive Surgery SOP ECS 1301- “Intraocular Pressure”
- Cornea, Cataract and Refractive Surgery SOP ECS 1302 - “Refraction”
- Cornea, Cataract and Refractive Surgery SOP ECS 1303 – “Contrast Sensitivity”
- Cornea, Cataract and Refractive Surgery SOP ECS 1304 –“Ultrasound Pachymetry”
- Cornea, Cataract and Refractive Surgery SOP ECS 1305 – “Pupilometry”
- Cornea, Cataract and Refractive Surgery SOP ECS 1306 – “Corneal Topography”
- Cornea, Cataract and Refractive Surgery SOP ECS 1307 – “Visual Acuity”
- Cornea, Cataract and Refractive Surgery SOP ECS 1308 –“Straylight measurement”
The Ocular Surface & Inflammation Expert Committee has prioritized and is writing 15 technical SOPs.
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