The following 32 topics are covered by HRC's SOPs:

  1. Writing and Maintaining SOPs
  1. Contact with Potential Sponsors
  1. Review of Protocol for Suitability
  1. Budget Review and Negotiations
  1. Planning Meetings
  1. Pre-study Qualification Visits
  1. Investigators Meetings
  1. Staff Training
  1. Essential Documents
  1. ICF Development
  1. Obtaining Informed Consent
  1. IRB Submissions
  1. Subject Recruitment
  1. Clinical Supply Receipt and Storage
  1. Study Drug/Device Storage
  1. Sponsor Site Initiation Visit
  1. Master Subject List Requirements
  1. Regulatory Binder Requirements
  1. Communications Documentation
  1. Source Documentation
  1. CRF Completion
  1. Study Drug/Device Accountability
  1. Sponsor Monitoring Visits
  1. On-going Regulatory Requirements
  1. Serious Adverse Event Reporting
  1. Medical Safety Reports
  1. Unblinding Process
  1. Data Clarification Forms
  1. Study Termination
  1. IRB Study Closure Report
  1. Audits
  1. Long-Term Storage
 

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In this section:
Introduction
The need for SOPs
Topics covered
Binders & Media

Having a prepared comprehensive set of Standard Operating Procedures will demonstrate the site’s intention of compliance in the event of an audit.