The same applied for satisfaction in relation to time spent working in the company. Our customer-centric approach allows us to provide our clients with the highest quality services covering all the scientific and operational aspects of clinical research. *To whom all correspondence should be addressed. N2 will ensure the SOPs are externally reviewed by an independent expert every two years or sooner, if dictated by changes in the above-noted regulations or guidance documents. R. Hattemer-Apostel, "Standard Operating Procedures—A Novel Perspective," Qual Assur J, 5 (4) 207–219 (2001). SOPs for the Conduct of Clinical Research * Templates are optional tools that can be used or revised per departmental procedures. SOPs are to be included as part of the research ethics application when the research involves: equipment or devices that have been created and/or built by the researchers to collect bio-metric or physiological data, or commercially produced equipment or devices that have been modified by the researchers, or are being used differently from the manufacturer's directions/terms of Very few respondents made specific proposals for SOPs that could actually be done without. The aim of the SOP Benchmarking project was to evaluate existing SOP systems on the basis of existing best practices and benchmarking, and to develop proposals for potential improvements. As clinical research continues to expand and clinical trials become more complex, there is increasing demand for the implementation and enforcement of universal guidelines to ensure standardization, consistency, and … Although the subjective impression is that the amount of regulation in companies has increased in recent years and is continuing to increase, it is felt that there is little leeway for reducing SOP systems. SOPs, or Standard Operating Procedures, are defined as “uniformly written procedures, with detailed instructions to record routine operations, processes and practices followed within a business organization.”. Not every SOP system is the same, and not every SOP is equally suitable for every organization. Most authors limit themselves to very basic suggestions (e.g., short, meaningful sentences, clarity, use of illustrations)1 or alternatively very detailed instructions,2 which are ignoring basic elements of instructional design. The vast majority was unable to identify SOPs that could be done without. None had a reduction in the past 12 months. In most companies, the existing SOP systems fully cover regulatory needs. The SOPs must be compliant with the regulations and guidelines and there needs to be a mechanism in place to ensure ongoing compliance by way of regular expert review. Responses in this survey were obtained from several companies who belong to the leading pharmaceutical companies in Europe. However, self-study is nonetheless essential as a basis for learning. In case global SOPs do interfere with local regulatory requirements, the latter prevail. There is also a plethora of different annexes such as flow charts, tables, job aids, completion guides, etc. One-quarter of the companies involve SOP writer specialists in drawing up SOPs. CRC SOP-03 Audits and Inspections. Respondents said one reason for violations and dissatisfaction among those working with SOP systems was the compilation process itself or the generation period/revision cycle. To get around this problem, 70% of companies draw up local supplements. It is for this reason that the SOPs you will receive appear as print only PDF documents. The document Standard Operating Procedures (SOPs) for Good Clinical Practice at the Investigative Site (the SOP Template) (2001) has been licensed by the HSC Department of Research from the Center for Clinical Research Practice, Inc. Regardless of training events, the surveyed companies said the SOP competency of employees is not reviewed systematically. 7. The survey was conducted in late autumn of 2009 to determine the current state of affairs among VFA member companies, identify the mood/opinion of their employees with respect to the current situation, and present proposals as to what sponsors could do to change their SOP systems or remedy any deficiencies and inadequacies. An average of 11 days per year is devoted to training, but this figure varied significantly among the respondents (Figure 2). A. The open-end answers clearly show that learning modalities cannot be viewed in isolation from the complexity or novelty of content, from the overall structure of the training system, or from the individual employee's level of experience: "The best setting to choose depends greatly on the content of the SOPs." The breakdown here again shows systematic differences between the relevant user groups. Instead, SOPs were criticized for being unclear and/or overloaded with abbreviations and jargon. Interestingly, online training programs with options to review learning outcomes have significantly higher acceptance rates than those without. Again, there are huge differences between SOP systems. It does identify potential for improvement in this area of such importance for the quality of clinical trials. SOP cycle and change management. The survey results also clearly show that training measures should not be analyzed in isolation from their particular context. GCP requires "the setting up and maintenance of quality control systems supported by written SOPs,3 but provides virtually no guidance on SOP system design. The Institutional Ethics Committee of FMCI, the FMIEC reviews, … SOP should address certain groups of users and contain only information relevant for those. In many cases, instructions concerning parts of processes (e.g., study initiation) are spread out among different sections of an SOP or even among a number of different documents (SOPs, instructions, appendices, etc.). Respondents also explicitly suggested combination with other learning modalities: self-study and online training for induction, face-to-face training to deepen understanding and for discussion. Whether and how subjective dissatisfaction in recent years correlates with SOP proliferation is evident from the following statements from management staff. Only a few articles looked into the complex regulatory environment of the pharmaceutical industry4 and the resulting principles of writing effective SOPs.5, 6. © At least eight weeks is suggested. Clinical research and practice. This increases the need for deviations either on the basis of pre-approved waivers or post-hoc documented violations. As well as being expected to be aware of the manifold legal requirements and international regulations such as the German Drug Law (AMG), GCP Regulation, ICH GCP, various European directives, and FDA guidelines to boot, in the case of global trials, employees are also confronted with an array of sponsor-generated quality management documents which frequently seem to consist of a tangled web of rules and regulations. © 2021 MJH Life Sciences and Applied Clinical Trials Online. Survey appraises the use of SOPs in clinical research from the sponsors' point of view. The only explanation is that SOPs may be written as no-frills "instructions" (who does what and how), as well as guidance (e.g., every single document, be it a simple letter to an investigating site, trial protocol template, or CRO communication plan). In contrast, clinical operations staff felt that a median of 10% of SOPs they have to comply with in their day-to-day clinical trial performance were superfluous. By standardizing these SOPs, we are aligning our clinical research activities across campus with the 1U4U vision. SOPs are designed to reflect 'how' a procedure is done, not 'why' it is done; the 'why' component is part of the training process. We are located on Treaty 6 / Métis Territory. The reported estimated length of SOP systems ranged from a few pages to complex SOP constructions with an estimated number of up to 8,500 pages. The aim is to provide employees with every possible aid in order to prevent errors. The SOP generation period from first draft through feedback periods to approval and release lasts 10 weeks on average. W. Bohaychuk and G. Ball, "Standard Operating Procedures for Clinical Research Personnel—Part 23," Qual Assur J, 9 (1) 40–49 (2005). Street Address 207 Schwartz Center, 800 E. Summit St., Kent, OH 44242-0001 Mailing Address 800 E. Summit St. Kent, OH 44242 3. Thus, the decision on depth of regulation is a task of the company. About 40% of management employees said that new or revised SOPs were often implemented unexpectedly and without "prior warning" by corporate headquarters. This seems to be more of a hindrance than a help in their daily work. Some suggestions can be derived from the above results, which will be closer looked at in a second article (Proposals for an Ideal SOP System): Gabriele Schmidt,* PhD, is Associate Director, Clinical Research/Country Clinical Quality Manager, Germany at Sharp & Dohme GmbH, Lindenplatz 1, 85540 Haar, Germany, e-mail: [email protected]. There may be several conditions under which companies increase the depth of regulation. The global and/or local SOP systems for conducting trials that exist alongside legislative requirements differ greatly between companies. 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