The need for each research site to have a documented and comprehensive set of procedures and processes or Standard Operating Procedures [SOPs] is a hot topic in clinical research today.

The 2002 TPD's¹ voluntary inspections demonstrated the lack of these procedures and processes to be one of the most frequent deficiencies at the site level. The FDA² asks to review SOPs when conducting site inspections, and sponsors are more frequently asking to review the site’s SOPs prior to placing new clinical trial contracts with the institution, as a demonstration of the site’s standards of practice.

HRC's SOPs

The SOPs developed by the Hegi Research Group are written in compliance with the International Conference on Harmonisation guidelines for Good Clinical Practices (ICH GCP), Canadian TPD regulations and USA FDA regulations. Each SOP is referenced to applicable regulations, guidelines and other SOPs.

This leading-edge set of manuals is written in user-friendly language and is designed to function as a training manual or orientation for new staff. Staff are encouraged to reference the applicable regulations, thereby increasing their own knowledge.

Many of the individual SOPs are supplemented by forms, checklists and templates that can be utilised by the site as efficiency tools in the day-to-day responsibilities of clinical research.

The printed manual - in excess of 170 pages - comes in an indexed binder format, with each section individually accessible using the electronic file format in Microsoft Word to accommodate easy revisions. SOPs can be customised to reflect the different practices at the clinic and additional SOPs for specific procedures can be added to the binder.

The SOPs should be reviewed and approved at the site and reviewed on a yearly basis to ensure continuing compliance. In this way, the SOPs are the basis for an evolving and constantly current set of documents.

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.

Cost

The three-part (2 binders and 1 electronic disc) Standard Operating Procedures for Clinical Research Sites© is available for $995.00 CDN plus GST (where applicable).

Individual Consultation

Additionally, HRC offers individual consultation to sites that require more advanced assistance with the SOPs on an hourly basis. We are experienced educators and available for in-service presentations and training seminars on the development and implementation of SOPs at the site.

Available in French

Working in conjunction with HRC, the SOPs set is available in French as provided by the clinical research consultancy group Leighis Consultants Inc. For more information, please visit the Leighis website at www.leighisconsultantsinc.ca
 

¹ [Canadian Therapeutic Products Directorate]
² [USA Food and Drug Administration]

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