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  4. Education is key for research audit preparedness

Education is key for research audit preparedness

Stories Nov 29, 2013 2 minutes

Upcoming workshop exemplifies accessible resources for VCH research staff.

As 2013 wraps up, the promise of a new year brings with it the possibility of more research audits. Fortunately, a variety of programs and resources are offered through VCHRI to better prepare VCHRI researchers.

“Making educational resources accessible – for example, they’re free of charge or available online – is an essential way in which we support our research community,” says Kerri Abramson, VCHRI coordinator of research education and internal awards. “We’re here to help staff prepare for audits and answer any questions they may have before, during, or after the process.”

VCHRI researchers and research staff are encouraged to attend the sessions because trends and regulatory requirements may change over time, according to Abramson.

On Wednesdsay, December 4, VCHRI’s workshop Influences, Findings and Trends 2013 will offer research staff greater understanding of regulatory requirements and insight as to how compliance regulations are interpreted. Presented by Jean Smart, quality compliance and quality management consultant from Smart Quality Assurance Services (SQAS), the session will highlight regulatory agencies’ and industry’s currently interests, areas of scrutiny, and where resources are shifting.

“Integrating quality into our research processes ensures subject protection and high quality research data,” says Stephania Manusha, regional manager of clinical trials administration at VCH. “That we offer such training and information for our researchers builds confidence among our teams and elevates VCH’s reputation as a research institute.”

Resources for researchers like you

  • Good Clinical Practice (GCP) online education modules: All clinical researchers in Canada are required to complete GCP training, which is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. All modules are now available online, at no cost, for VCHRI researchers and research staff.
  • Audit & Inspection Preparedness Program (AIPP): Launched in spring 2013, AIPP was developed by VCHRI as a series of six workshops on proper processes, auditor expectations, and conduct during a research audit. The online AIPP component is a comprehensive resource toolkit containing helpful items such as training log templates to mock Health Canada audit interview sessions.
  • VCH’s Standard Operating Procedures (SOPs) are also available through the AIPP website and are an accessible resource for all VCHRI researchers and research staff.

 

For more information about access to VCH’s AIPP website and SOPs, contact Stephania Manusha at stephania.manusha@vch.ca.

Enquiries about education and workshops can be sent to Kerri Abramson at kerri.abramson@vch.ca.

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