HRC's printed SOP manual - in excess of 180 pages - comes in an indexed binder format. This includes 37 separate SOPs and 22 forms/ templates. Each section is individually accessible using the electronic file format in Microsoft Word to accommodate electronic viewing and easy revision. Templates and checklists are accessible as individual documents for use at your site. SOPs can be customised to reflect the different practices at the clinic and additional SOPs for specific procedures can be added to the binder.

Internet and phone consultation with our SOPs consultants is offered as a free follow-up service with every purchase.

A second binder – Staff Training Records – completes the three-part set. This binder is designed to consolidate all the education and training records of the site staff for review by sponsors and regulatory auditors. It is accompanied by easy to follow instructions on how to organise the information.


 
Sample SOP

We have provided a sample of the SOPs. The following pdf is taken from the topic "Obtaining Informed Consent". Obtaining Informed Consent.pdf


 
Topics covered

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


 
SOPs Are Also Available in French
 
binders
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