CRQ posts procedures to enhance research quality, efficiency and compliance
The Clinical Research Quality office has just released a new library of Standard Operating Procedures (SOP) aimed at helping groups conduct quality human-subject research more efficiently and in compliance with laws and regulations.
As a research institution, Stanford University must comply with laws, policies and regulations established by the Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), the International Conference on Harmonization guidelines (ICH), and the State of California.
SOPs break down regulations or policies into smaller pieces and provide step-by-step instructions for carrying out associated research activities. They also help protect the rights, welfare and safety of our valued human participants, as well as the integrity of the data generated from these studies.
In many cases, an SOP can save clinical trial coordinators time. For example, “SOP-006 The Informed Consent Process,” clarifies when a research participant must be reconsented, when reconsenting is recommended, and importantly, when it is not helpful to ask participants to sign a new informed consent form.
Because research methodologies and medical technologies are advancing faster than the laws that regulate them, SOPs play an important role in providing guidance for both old and new research categories. For example, “SOP-004 Investigational Product Accountability,” provides guidance to teams studying a range of products, from low risk mobile medical application devices to new cardiac valves. The FDA does provide some guidance on how to interpret the law in evolving areas, but it also expects institutions to establish their own standard practices.
The SOPs related to the Good Clinical Practice standards that everyone in the School of Medicine is expected to follow are created by the Clinical Research Quality office. Additionally, any department, lab or clinical trial office can create its own SOPs with the approval of their department, center leadership, or the principal investigator in a lab, as long as those local SOPs don’t conflict with School procedures.
Once standards are created, SOPs are implemented via training and communication through programs such as Spectrum’s workforce development program and the Clinical Research Operations Program. They can be incorporated into any department’s existing training program. The Clinical Research Quality office also conducts periodic audits to identify areas where researchers may need additional training, or to alert the office to SOPs that should be created or amended. A good SOP is one that provides just enough direction to facilitate compliance and support consistent research procedures without getting in the way of innovation and discovery.
CRQ has developed a short presentation, accessible via STARS, that provides a high-level overview of clinical research policies and procedures at Stanford.
To modify or propose the creation of a new SOP, go to the CRQ SOP web page and submit a request by clicking on the “Document Change Request Form” link or the “Document Initiation & Development Request” link.
To review the new library SOPs and learn about available training visit the SUnet-protected website: http://med.stanford.edu/spectrum/b4_research_quality/b4_3_standard_operating_procedures.html
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