SOPs Topics Purchase SOP set

 In this section:

Introduction
The need for SOPs
Topics covered
Binders & Media
Purchase

We are experienced educators and available for
in-service presentations
and training seminars on the development and implementation of SOPs at the site.

The following topics are covered by HRC's SOPs:

Writing and Maintaining SOPs
Contact with Potential Sponsors
Review of Protocol for Suitability
Budget Review and Negotiations
Planning Meetings
Pre-study Qualification Visits
Investigators Meetings
Staff Training
Essential Documents
ICF Development
Obtaining Informed Consent
IRB Submissions
Subject Recruitment
Clinical Supply Receipt and Storage
Study Drug/Device Storage
Sponsor Site Initiation Visit


 

Master Subject List Requirements
Regulatory Binder Requirements
Communications Documentation
Source Documentation
CRF Completion
Study Drug/Device Accountability
Sponsor Monitoring Visits
On-going Regulatory Requirements
Serious Adverse Event Reporting
Medical Safety Reports
Unblinding Process
Data Clarification Forms
Study Termination
IRB Study Closure Report
Audits
Long-Term Storage


 

 
 

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