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We have Standard Operating Procedure (SOP) for each step of the clinical trials at our site. This is often known as site SOP
- SOP 1 – Preparing and maintaining SOPs
- SOP 2 – Staff Training and Education
- SOP 3 – Roles & Responsibility of study team members
- SOP 4 – Communication with IEC
- SOP 5 – Subject Recruitment Process
- SOP 6 – Source Documentation
- SOP 7 – Obtaining Informed Consent
- SOP 8 – Investigational Product Accountability, Storage, Dispensing and Return
- SOP 9 – Management of Adverse Events/ Serious Adverse Events and Safety Reporting
- SOP 10 – Retention of Study Documents