The size/scope of SOP systems evidently differs greatly between companies indicating that SOP systems can display significant differences and may not always be directly comparable. 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 SOP length/level of detail. 3. This seems to be more of a hindrance than a help in their daily work. Standard Operating Procedures for Clinical Trials (SOPs) Procurement Attendance Vehicle use Seventy five percent of employees also said self-study was one of the most important ways of learning SOPs. The reference list of regulations at the end of the procedure includes the applicable 'why' documents. 4 . Here is a simple example of … Training of all parties involved in the process is indisputably a key responsibility of sponsors. They are available to all University research teams and can be found here. The SOP generation period from first draft through feedback periods to approval and release lasts 10 weeks on average. What are SOPs? CRC SOP-01 Adverse Effects. Here again, however, there was a trend toward dissatisfaction with overly detailed descriptions as a function of time spent working for the company (> 10 years of job experience). It is therefore no surprise, as the survey shows, that the level of detail is seen to be either helpful or restrictive depending on the individual employee's level of experience. Diversity in trial design, study sponsor, therapeutic area, investigator and coordinator experience, etc. 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. About 40% of management employees said that new or revised SOPs were often implemented unexpectedly and without "prior warning" by corporate headquarters. United States Environmental Protection Agency, "Guidance for Preparing Standard Operating Procedures (SOPs)," QA/G-6, (2007), SOP management. Documents that assist the sites to 'bridge' between the SOPs and site-specific/local procedures (tools, checklists, sample forms, local guidance documents) are not part of the official SOP and can be created or adapted as needed, to meet the needs of the end user and as such. In clinical research, the International Council for Harmonisation (ICH) defines SOPs as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs for the Conduct of Clinical Research * Templates are optional tools that can be used or revised per departmental procedures. Sixty five percent said they were included in discussions about new SOPs, and their feedback is adopted/integrated in documents in more than 70% of cases. Irrespective of their function or role in clinical research and time with the company, 19% of respondents were fully, 57% partly, 16% less, and 8% not at all satisfied with the current SOP system in their company. All rights reserved. Are SOPs more restrictive than the legislative framework? The aim is to provide employees with every possible aid in order to prevent errors. Again, there are huge differences between SOP systems. CRO SOPs were used in less than one-third of cases. The global and/or local SOP systems for conducting trials that exist alongside legislative requirements differ greatly between companies. SOPs should be easy to search and according to simple process maps. Policy MG.O-001 — Clinical Research Billing Compliance with Medicare Requirements (Version Date: 5/16/2016) Procedure MG.O-001.01 — OnCore Pathway to Billing Compliance (Version Date: 5/15/2018) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, … This is a good result. The survey shows that there is neither a uniform hierarchy/structure in respect to SOP documents, nor in terms of nomenclature of document types. The Institutional Ethics Committee of FMCI, the FMIEC reviews, … Although analysis of survey outcomes reveals deficiencies in the system and a need for improvement and change in some areas, the benefit of SOPs is nonetheless accepted. Nonetheless, formal learning was deemed the best method of learning (80% of companies that said this was mostly or occasionally the case). 8. The survey results also clearly show that training measures should not be analyzed in isolation from their particular context. The Office of Quality Compliance has created Standard Operating Procedures (SOPs) to be used by all individuals participating in clinical research at the University of Utah. Monitors and project managers were asked which quantity of training they would consider to be the most appropriate. However, this learning method lacks feedback on learning outcomes, which could be the reason for the lower acceptance among users. One-third do not regularly check competency, 15% only in isolated cases, if the manager notices deficits or an audit identifies any deficiency. 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. 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. SOPS need to reflect the regulations and guidance documents that govern clinical research and do NOT need to be site/institution specific. The survey showed that some SOPs are implemented with no lead time and may be implemented even in normal situations within as short a period as four weeks. One-quarter of the companies involve SOP writer specialists in drawing up SOPs. SOPs ensure that sites follow Federal Regulations, International Conference on Harmonization Good Clinical Practice Guidelines, and UH Institutional Policies to protect the rights and welfare of human study participants. Are SOPs useful in your daily work? Standard Operating Procedures Regulatory authorities require that clinical research sites use standard operating procedures (SOPs) to ensure that their research is conducted in manner that protects the rights and safety of study subjects and the integrity of the research data collected. About 40% said there had been no change regarding the estimated number of global or local SOPs. Interactions with IEC (Institutional Ethics Committee) SOP. is very important and widespread. Our procedures have been developed according to the specific work groups within ECTU. Lead times from announcement to enforcement of an SOP were four weeks on average. Both training providers and recipients recognize the responsibilities of employees in the learning process. About two-thirds of respondents said internal company SOP systems were more restrictive than applicable law. 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." Affiliates and subsidiaries are involved in the generation of global SOPs in addition to corporate headquarters. © There seems to be high congruence between providers and recipients of training with regard to the amount of time required. "Details of a single process need to be searched for in multiple SOPs." About 45% of employees said they never deviated from an SOP. Size and structure. This situation is due in no small measure to the fact that there has been little or no debate to date on what constitutes "adequate quality" of an SOP system. The result is employee dissatisfaction and demands for improvement of the content, a reduction in the number of SOPs, and improvement in the way the content is presented. It should be noted that the SOPs contain minimal text copied from regulations and explanations of why procedures are done. About 30% put national laws ahead of company instructions and implement this policy without any formal modification/amendment of the global SOP. The reviewer may ask to look at the facilities where the research is conducted to ensure it is being done according to the requirements listed in the protocol and that all research equipment has been calibrated and located* as per protocol/SOPs. In contrast to size/scope, there were no major differences in satisfaction between monitors and project managers in respect of level of detail. The breakdown here again shows systematic differences between the relevant user groups. What works for one company need not be the best solution for another. SOPs are intended to support compliance with laws and regulations that govern the conduct of clinical research. CRC SOP-02 Assessing Protocol Feasibility. 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). Users saw clear potential for improvement in implementing a level of document detail suited to the specific tasks and responsibilities, combined with a rapid and accurate search feature. The vast majority was unable to identify SOPs that could 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. Three-quarters of the surveyed monitors and project managers said they sometimes had to deviate from an SOP in their day-to-day work. In nine cases the company was the local affiliate of a global corporation. © 2021 MJH Life Sciences™ and Applied Clinical Trials Online. Training should be combined with adequate feedback and learning control. The total number of SOPs and in particular the estimated number of pages—8,500 for one company—showed a wide range of variation. Training with formal review of learning outcomes accounted only for a median of 7.5% of training events. The investigator team should be trained in GCP/GLPor ethics in clinical research The research team should refer to study specific SOPs for further details of carrying out the specific study protocol. Clinical trial agreement log. By standardizing these SOPs, we are aligning our clinical research activities across campus with the 1U4U vision. Thirty five percent of respondents said the SOPs were not clearly structured, monitors more so than project managers. The German Association of Research-Based Pharmaceutical Manufacturers—Verband Forschender Arzneimit-telhersteller (VFA)—appointed a taskforce from the Clinical Research and Quality Assurance subcommittee to look into the topic. This will greatly facilitate distribution, adoption and maintenance of one standard. SOPs - Any - Administration Clinical Research Governance and Sponsorship Human Resources Monitoring Quality Assurance Safety Reporting Use the dropdown to search for dowloadable SOP … The three-peak distribution shows peaks at five, 10, and 20 days. 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.). Apart from the need to scrutinize the wish to change SOPs, sufficient time should be left between finalization and the date of coming into effect of an SOP. The goal was to develop one set of well-written SOPs that would cross all therapeutic areas in any given institution or research environment. Authors of SOPs tread a thin line in general, because user expectations and needs are as diverse as the spectrum of SOPs in existence. On average, the time required for training according to the results of this survey is about 5% of total working hours, with a very evident wide range of variability among the companies. It derives from the requirement that sponsors must ensure that all involved parties are properly qualified.7 However, there are no specific requirements as regards the methods used to qualify staff. Involvement in SOP compilation did however not correlate with level of satisfaction. CRC SOP-04 Case Report Forms. A two- to three-year cycle may be appropriate, but is not based on hard evidence. This list is not all-inclusive. Fifteen percent of companies check their employees' knowledge of the main SOPs at least once a year. Survey appraises the use of SOPs in clinical research from the sponsors' point of view. Twenty five percent of respondents said existing SOPs were not coherent and comprehensive. A template for Standard Operating Procedures (SOPs) for Clinical Research at Health Sciences Centre is available through the Health Trials office. Clinical research and practice. It does identify potential for improvement in this area of such importance for the quality of clinical trials. Analysis of frequency of training and refresher cycles indicates that "not forgetting" is the primary element addressed. Only a few articles looked into the complex regulatory environment of the pharmaceutical industry4 and the resulting principles of writing effective SOPs.5, 6. Responsibility, workflow, and personal accountability should be clearly defined in an SOP. This opinion was more commonly expressed by project managers than by monitors. 1. Policies & SOPS Clinical research is a rapidly growing and evolving field in healthcare. 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. Office of the Vice-President (Research and Innovation), Regulations, Guidelines & University Policies. Such a conclusion is too simplistic—it is important to analyze the underlying chain of circumstances as a means of initiating appropriate, reactive, or proactive measures. The expertise of SOP authors was largely rated favorably; only 10% of respondents said SOP authors tended to be far removed from reality. SOPs describe specific procedures performed during the conduct of a clinical research study involving human subjects. SOPs in Clinical Research SOP benchmarking project. There is also a plethora of different annexes such as flow charts, tables, job aids, completion guides, etc. The SOPs are based on ICH: Good Clinical Practice guidelines, Health Canada Food and Drug regulations, and Tri-Council Policy Statement guidelines for the ethical conduct of research involving humans. A mere 15% of those involved in document compilation said they were actual authors; most were involved only in the review/feedback process. Differences are also apparent in terms of the roles and responsibilities of respondents, for instance between monitors and project managers. University of Alberta 116 St. and 85 Ave.. We are located on Treaty 6 / Métis Territory. The main criticisms of existing SOP systems concerned the complexity and lack of clarity of individual documents/SOP systems, which made it more difficult for users to rapidly seek and find the relevant sections/instructions required for day-to-day work or in a specific on-site situation. SOPs with large numbers of pages did not necessarily receive poorer ratings. SOPs are designed to reflect 'how' a procedure is done, not 'why' it is done; the 'why' component is part of the training process. The needs of career starters differ from those of employees who have worked in the company or in clinical research for longer. ICH GCP section 5.1.1 merely states that sponsors are obliged to implement an effective quality management system with written SOPs. Edmonton, AB, Canada T6G 2R3 Clinical trial agreement log. •Founded in federal regulations and guidance, Good Clinical Practice guidelines, and institutional policies and guidance •General processes common to running all studies •Infrequent changes •Established in a grant, protocol, and/or IRB application •Study-specific processes to gather data for one study’s research aims •Changes throughout the life of the study (updated with each new Modification) Existing SOP systems including the associated training were to be analyzed and improvement proposals were to be designed as appropriate on that basis. SOP compilation and SOP quality. In this survey, face-to-face/classroom training had the highest level of acceptance. 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. SOP cycle and change management. SOP deviations and violations. In more than 80% of reported cases, a change in legislation was the reason for an SOP revision or creation of a new SOP. An average of 11 days per year is devoted to training, but this figure varied significantly among the respondents (Figure 2). Very few respondents made specific proposals for SOPs that could actually be done without. Systems with fewer pages (in reference to monitoring) also tended to be rated more favorably. Nancy Paris elevates cancer treatment and research in Georgia Nancy Paris … SOPs are described overall as too lengthy. The starting point for this survey was the impression that employees are relatively dissatisfied with their SOP systems. "Search features in the electronic SOP repository are ineffective." SOP training. This library of SOPs is a resource for anyone conducting clinical research at the University of Utah to ensure consistency and compliance to Good Clinical Practice. You may edit and adapt for your department. "Sometimes it is not easy to find the right SOP you need for a particular process.". Comparison of job areas and processes with a largely pre-dictated scope of regulation (e.g., monitoring, SAE reporting, audit conduct, and collaboration with third parties/CROs) gives a similar picture. 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. Almost the same number (about 42%) said they deviated one to two times per year, and only a few said they had to deviate more than three times or five times per year. N2 SOPs (V.8, May 2019) are available to University of Alberta researchers conducting biomedical and clinical research. A. Below are some of the commonly referenced SOPs used in the Clinical Research Center. The UBC Research Ethics Board SOPs were updated and approved May 2018, and are now in line with the N2/CAREB-ACCER REB SOPs. They improve quality of data collected and improves research, Provide a reference and guideline for conducting research, and All rights reserved. Only two companies reported a specific need for regulation in particular areas. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) Questions were asked about handling and satisfaction with the existing SOP system/training methods, and respondents were asked to make proposals for possible future systems and methods. Thus, the decision on depth of regulation is a task of the company. In about 70% of companies, additional local processes and SOPs are generated to supplement the corporate regulations in order to reflect and implement local/regional needs and legislative requirements. Respondents said processes were overregulated (not including those relating to clinical trials but not originating in clinical research) in about 5% (median) of all processes described. Existing SOP systems in clinical research. At least eight weeks is suggested. A similar situation applied (almost 90%) with respect to structural changes within companies that entailed adaptation of processes and responsibilities. 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. Dieter Baier, PhD, is General Secretary of Medical and Scientific Excellence at Roche Pharma AG. Clinical Research Policies and SOPs Joint GU/MHRI Policies and Procedures. In case global SOPs do interfere with local regulatory requirements, the latter prevail. Regulatory authorities require that clinical research sites use standard operating procedures (SOPs) to ensure that their research is conducted in manner that protects the rights and safety of study subjects and the integrity of the research data collected. We are located on Treaty 6 / Métis Territory. Accelerating and Advancing Patient Care. There are still acceptance problems among users nonetheless, in particular if the training provides no means of checking learning outcomes. Adverse Event (same as Adverse Drug Experience, Adverse Experience, Adverse Drug Reaction, Adverse Reaction) CHNw . A detailed survey—which would appear to be representative given the extent of feedback obtained—indicates that satisfaction may not be dependent on the size and structure of the SOP system. Only a few marginal areas/exceptions were mentioned which still have to be covered by SOPs in individual companies. 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 … … Online training, on the other hand, evidently seems to have become widespread. Two-thirds of companies rejected the prospect of ad-hoc training provided only to meet an acute need and if a particular process was specifically required. 2019 Conversely, gap analysis revealed little or no need to extend the SOP system. 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. 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]. Content was primarily the job of the companies surveyed said learning SOP content primarily... In recent years correlates with SOP systems in clinical research, SOPs were used in less one-third... Sop ’ s ( e.g., medical directors, directors of clinical research to be by. Uniform hierarchy/structure in respect to structural changes within companies that entailed adaptation of and... To support compliance with laws and regulations that govern the conduct of clinical investigation, personal... Sop documents, nor in terms of the company conversely, gap analysis revealed little no. 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