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SOPs - Standard Operating Procedures - have a place in our business. Love ‘em or hate ‘em, they help to ensure quality and consistency in our performance and protect study volunteers. You may consider some SOPs more critical than others and some even unnecessary. Maybe, like me, you think there's no clear-cut set of SOPs established for clinical research sites.
We want to hear your perspective. We are looking for input, via a specially designed survey, to get a handle on creating a table of contents of SOPs that sites should have. You can link to the survey below, but first, here's the context for this issue....
SOPs are not specifically mentioned in the FDA regulations; however, there are regulations and guidance that infer responsibilities. SOPs formalize investigator responsibilities and 21 CFR 312.53 states the Investigator will "ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed of their obligations in meeting the above commitments."1
While SOPs are not required by the FDA, the agency often notes when it issues Form 483 that sites need SOPs to address deficiencies. The International Conference on Harmonization (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function." Organizations involved in clinical research - pharmaceutical companies, sponsors, contract research organizations, investigator sites, ethics committees or any other parties - require SOPs to achieve maximum safety and efficiency of the performed clinical research operations. All people and sites involved in clinical studies (both at the sponsor and the investigative sites) must have appropriate SOPs in place in order to conduct clinical research in compliance with current ICH regulations.
No one disputes the benefit or need for SOPs. But once again, sites are expected to adhere or measure up to a standard that is not clearly identified.
That brings us to the survey. With your help, we want to identify SOPs you believe to be critical, those nice to have, and those not needed at all by reputable clinical research sites. By completing the survey (link below), you can contribute to this list. Additionally, please chime in here with any comments you have on the subject. The results of the survey will be posted on a future BLOG. Those who contribute and provide their e-mail address will receive a complete copy of the final list of Site SOPs Table of Contents.
Thanks for your help!
Complete our survey here: http://www.surveymonkey.com/s/YTG5CJK
1Karen Majchrrzak, MS, CCRP: A Blueprint for Clinical Research: Standard Operating Procedures.
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