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