Twenty five percent of respondents said existing SOPs were not coherent and comprehensive. Affiliates and subsidiaries are involved in the generation of global SOPs in addition to corporate headquarters. 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]. B. Jones, "Principles in Quality Assurance," Qual Assur J, 6 (4) 219–225 (2002). 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. 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. … What are SOPs? You may edit and adapt for your department. 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. There was no correlation with time spent with the company. The expertise of SOP authors was largely rated favorably; only 10% of respondents said SOP authors tended to be far removed from reality. 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. Both training providers and recipients recognize the responsibilities of employees in the learning process. University of Alberta 116 St. and 85 Ave., Clinical trial agreement log. Our procedures have been developed according to the specific work groups within ECTU. standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, … In addition to regular review of SOPs at intervals of two to three years, there are other important reasons for revision. ICH GCP section, 5.1.1, 5.4.1, http://ichgcp.net/. Creating SOPs for the clinical research staff provides written guidance and train - ing for investigator and staff. Below are some of the commonly referenced SOPs used in the Clinical Research Center. M. Spitzer, "Born to Learn," Journal for International Perspectives, 4 (2004). SOP should address certain groups of users and contain only information relevant for those. Project managers tended to find them even more restrictive than monitors. It is for this reason that the SOPs you will receive appear as print only PDF documents. Fifteen percent of companies check their employees' knowledge of the main SOPs at least once a year. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc...) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidance. The main reasons cited for necessary deviations were "unfeasibility," as well as (lack of) time, effort, and cost. In most companies, the existing SOP systems fully cover regulatory needs. Only two companies reported a specific need for regulation in particular areas. © In case global SOPs do interfere with local regulatory requirements, the latter prevail. At least eight weeks is suggested. *To whom all correspondence should be addressed. 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. The results hence reflect relevant experience of SOP systems in the pharmaceutical industry. Interactions with IEC (Institutional Ethics Committee) SOP. The literature has comparatively little to say about what an optimal SOP system can and should look like. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) The baseline hypothesis (i.e., that SOP systems in GCP as they now exist would be rated inadequate by corporations and users) is not strongly supported. Survey appraises the use of SOPs in clinical research from the sponsors' point of view. According to the respondents, corporate headquarters are responsible for SOP authorship in 60% of the surveyed companies. For monitoring (site selection/pre study visits, study conduct, study completion, and close out visit), the scale ranged from one to 35 SOPs (Figure 1) and from 10 to 700 pages. This extends to detailed specification of formats for templates/forms. 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. All rights reserved. The questions related only to SOP systems used to conduct Phase I to Phase IV clinical trials and did not cover health outcome studies or non-interventional studies. 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.”. Documents intended to be globally applicable were frequently mentioned in this context; respondents said global documents tend not to contain clear information/delimitations for each area (global/local functions). Only 27% of respondents were happy with system size/scope and less than half (48%) were happy with the level of detail. The needs of career starters differ from those of employees who have worked in the company or in clinical research for longer. Analysis of frequency of training and refresher cycles indicates that "not forgetting" is the primary element addressed. 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. The reference list of regulations at the end of the procedure includes the applicable 'why' documents. Existing SOP systems in clinical research. 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. 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. 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 breakdown here again shows systematic differences between the relevant user groups. An SOP is a written process of how tasks are completed and who is responsible. 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. 203-S01 Essential Regulatory Documents Required for a Clinical Study SOP 204-S01 Emergency Use of Qualified Non-NIH Facility SOP 205-S01 Clinical Site Monitoring Plans - Development and Maintenance SOP 301-S01 Evaluating Serious Adverse … Changes to the formal set of SOPs at the site/institutional level are NOT recommended and may result in the SOPs no longer being compliant. 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. Purpose of SOPs It is from the expectations and require- ments of this guideline that the focus moves The purpose of an SOP is to convey a set of to the assurance that a clinical study is instructions on a method or practice to the conducted according to generally accepted user or individual who will perform the practices for clinical research, defined as function. This is a good result. As already mentioned at the outset, existing regulations do not dictate the depth of regulation in SOPs. Clinical project managers, monitors and assistants in the pharmaceutical industry involved in conducting clinical trials are experiencing increasing regulation. Deviations resulting from a discrepancy between global SOPs and local legislation are handled in different ways. It is strongly recommended that only one set of SOPs and related documents be used. Clinical trial agreement log. 8. Replies from the two surveys were encrypted by VFA via company code so that it was possible to match management responses to employee responses, but without revealing the identity of individual companies and persons in the evaluation. The answer was approximately nine days, again with significant variation. Arthur Hecht is Head of QM-M&R, Germany at Boehringer Ingelheim Pharma GmbH & Co KG. Globally operating companies have an additional problem: global SOPs and procedures may need to be expressed in very general terms to ensure that they cover all responsibilities and areas throughout the organization and should not interfere with country-specific regulations. More than 70% of the surveyed companies involve the line departments and about 50% involve quality assurance in SOP compilation. 4. There may be good reasons why SOPs are modified at very short notice, for instance, an imminent regulatory requirement or the need to avoid damage to study participants. 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. They improve quality of data collected and improves research, Provide a reference and guideline for conducting research, and The main reason seems to be the feedback on learning outcomes, which can be gained from following class discussion and asking questions about the content. Standard Operating Procedures (SOPs) in Clinical Trials are the standard documents that define the procedure, which must be followed to ensure that standards are followed while carrying out research. SOP training. Involvement in SOP compilation did however not correlate with level of satisfaction. 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. Even more respondents (88%), however, said face-to-face training was the best learning method. About 45% of employees said they never deviated from an SOP. 2019 MCW Cancer Center SOPs for Research Staff . Inspectors tend to attribute non-compliance with process descriptions to inadequate training. Results. Clinical Research Policies and SOPs Joint GU/MHRI Policies and Procedures. However, acceptance of this method increased if it was linked with review of learning outcomes (58%). Michael Herschel, MD, is Director Clinical Research at Glaxo Smith Kline Pharma GmbH & Co KG. 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. One-third do not regularly check competency, 15% only in isolated cases, if the manager notices deficits or an audit identifies any deficiency. University of Alberta 116 St. and 85 Ave.. We are located on Treaty 6 / Métis Territory. W. Bohaychuk and G. Ball, "Standard Operating Procedures for Clinical Research Personnel—Part 23," Qual Assur J, 9 (1) 40–49 (2005). The survey shows that there is neither a uniform hierarchy/structure in respect to SOP documents, nor in terms of nomenclature of document types. SOPs usually get applied in pharmaceutical processing and for related clinical studies. The former bears the risk of heterogeneous implementations. SOPs for the Conduct of Clinical Research at Sunnybrook Regulatory authorities require that clinical research sites utilize standard operating procedures (SOPs) to ensure that their research is conducted in a manner that protects the rights and safety of study subjects and … Another important issue was to determine whether specific SOP concepts were associated with higher "satisfaction" on the part of the parties concerned in their respective functions. United States Environmental Protection Agency, "Guidance for Preparing Standard Operating Procedures (SOPs)," QA/G-6, (2007), http://www.epa.gov/quality/qs-docs/g6-final.pdf. About two-thirds of respondents said internal company SOP systems were more restrictive than applicable law. document.write(new Date().getFullYear()); 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. Systems with fewer pages (in reference to monitoring) also tended to be rated more favorably. Seventy five percent of employees also said self-study was one of the most important ways of learning SOPs. CRC SOP-03 Audits and Inspections. Detailed evaluation showed that monitors tended to be more satisfied with lengthy SOPs than project managers. 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 … To name just a few, the terms employed include SOP, policy, operating instruction, and working instruction. The mean number of SOPs a study manager/project manager in clinical research had to be familiar with was approximately 50 SOPs/480 pages. Instead, SOPs were criticized for being unclear and/or overloaded with abbreviations and jargon. A template for Standard Operating Procedures (SOPs) for Clinical Research at Health Sciences Centre is available through the Health Trials office. 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." We’re challenging existing models of care with new ideas across the spectrum of discovery—from basic science, to clinical trials, to public policy changes. Accordingly, self-study (read and sign, etc.) LIST OF ABBREVIATIONS. The results of this survey indicate that the use of this method has become rather rare. The drawback of this learning modality is the comparatively high cost. SOPs are designed to reflect 'how' a procedure is done, not 'why' it is done; the 'why' component is part of the training process. A similar situation applied (almost 90%) with respect to structural changes within companies that entailed adaptation of processes and responsibilities. Description of project/survey conduct. What works for one company need not be the best solution for another. It does identify potential for improvement in this area of such importance for the quality of clinical trials. AE . Increase and overregulation of processes—potential for reductions. ", Many respondents cited the difficulty in finding individual process steps within an SOP system as being a key problem. 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. Regulatory authorities require that clinical research sites utilize 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. SOPs in Clinical Research SOP benchmarking project. 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. The goal was to develop one set of well-written SOPs that would cross all therapeutic areas in any given institution or research environment. In respect of cooperation with CROs, it emerged that sponsor SOPs were used as a basis for study conduct in approximately two-thirds of cases. Specifications hence need to be developed independently. http://www.epa.gov/quality/qs-docs/g6-final.pdf. A mere 15% of those involved in document compilation said they were actual authors; most were involved only in the review/feedback process. Responses in this survey were obtained from several companies who belong to the leading pharmaceutical companies in Europe. One-quarter of the companies involve SOP writer specialists in drawing up SOPs. SOPS need to reflect the regulations and guidance documents that govern clinical research and do NOT need to be site/institution specific. An average of 11 days per year is devoted to training, but this figure varied significantly among the respondents (Figure 2). Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. 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. 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 A. However, self-study is nonetheless essential as a basis for learning. R. Hattemer-Apostel, "Standard Operating Procedures—A Novel Perspective," Qual Assur J, 5 (4) 207–219 (2001). In this survey, face-to-face/classroom training had the highest level of acceptance. The subjective feeling of many respondents seems to be that "less is more. SOPs with large numbers of pages did not necessarily receive poorer ratings. 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. A high level of regulation also carries the risk of making more mistakes and unintentionally violating an SOP. This list is not all-inclusive. SOPs should be oriented to a process and not to specific functions. In the authors' experience, this would generally be an insufficient period of time to give employees the chance to familiarize themselves with the new procedure and complete the necessary training. The total number of SOPs and in particular the estimated number of pages—8,500 for one company—showed a wide range of variation. Whether and how subjective dissatisfaction in recent years correlates with SOP proliferation is evident from the following statements from management staff. Two questionnaires were designed for the survey: Questionnaire 1 (Table 1) about the cost and benefit of SOPs looked at the existing structure and size/scope of the company's existing SOP system in terms of GCP, SOP management, and presentation of SOP content. Less than half of respondents (43%) said e-learning was the best method. 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. 6. Accelerating and Advancing Patient Care. SOPs - Any - Administration Clinical Research Governance and Sponsorship Human Resources Monitoring Quality Assurance Safety Reporting Use the dropdown to search for dowloadable SOP … Online training, on the other hand, evidently seems to have become widespread. There may be several conditions under which companies increase the depth of regulation. 4 . 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. In nine cases the company was the local affiliate of a global corporation. Few ways of streamlining processes or eliminating SOPs showed up. These SOP’s help the research teams, as recommendations for conducting research in the appropriate manner. Very few respondents made specific proposals for SOPs that could actually be done without. Regardless of training events, the surveyed companies said the SOP competency of employees is not reviewed systematically. ICH GCP section 5.1.1 merely states that sponsors are obliged to implement an effective quality management system with written SOPs. Only a few articles looked into the complex regulatory environment of the pharmaceutical industry4 and the resulting principles of writing effective SOPs.5, 6. 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). SOPs were primarily found to be useful (approximately 85%), irrespective of duration of job experience, even more so by monitors than by project managers. There is also a plethora of different annexes such as flow charts, tables, job aids, completion guides, etc. A total of 18 companies took part in the survey, the majority of which is represented by a member in the already mentioned subcommittee. The survey results also clearly show that training measures should not be analyzed in isolation from their particular context. Dieter Baier, PhD, is General Secretary of Medical and Scientific Excellence at Roche Pharma AG. 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. Standard Operating Procedures (SOPs) Quality assurance for clinical trials. may require unique approaches to specific clinical … The aim is to provide employees with every possible aid in order to prevent errors. 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. We are located on Treaty 6 / Métis Territory. About 40% said there had been no change regarding the estimated number of global or local SOPs. Three-quarters of the surveyed monitors and project managers said they sometimes had to deviate from an SOP in their day-to-day work. Estimation/user satisfaction with the currently established SOP system. This information belongs in policies, not procedures. "Details of a single process need to be searched for in multiple SOPs." The Network of Networks' (N2) SOPs have been developed to be a national standardized set of operating procedures that are applicable to any therapeutic area. SOPs are intended to support compliance with laws and regulations that govern the conduct of clinical research. 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. As a member of N2, the University has access to a set of fully vetted SOPs. 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. •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) What does makes sense, though, is for clinical research sites to establish standards for those responsibilities that regulatory authorities have attributed to the investigator—responsibilities that are subject to inspection. The associated need for additional material on local processes was seen to result in unreasonable multiplication of process descriptions. Are SOPs more restrictive than the legislative framework? 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. Half of the companies' management staff surveyed saw little or no potential for reductions (two SOPs on average). A two- to three-year cycle may be appropriate, but is not based on hard evidence. There are still acceptance problems among users nonetheless, in particular if the training provides no means of checking learning outcomes. 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. Policies & SOPS Clinical research is a rapidly growing and evolving field in healthcare. Comprehensibility/clarity of SOPs. SOP compilation and SOP quality. Interactions with IEC (Institutional Ethics Committee) SOP. SOPs should be easy to search and according to simple process maps. Almost half of the respondents reported little or no personal involvement in the creation of SOPs. These SOPs have been reviewed by an expert regulatory consultant and are compliant with Health Canada and US Food and Drug (FDA) regulations, the ICH-GCP Guidelines and the revised Canadian Tri-Council Policy Statement on Research Involving Human Subjects. Training of all parties involved in the process is indisputably a key responsibility of sponsors. Differences are also apparent in terms of the roles and responsibilities of respondents, for instance between monitors and project managers. This opinion was more commonly expressed by project managers than by monitors. 7. On average, the actual time required from the training recipient's point of view exceeds the nominal amount by only two days (11 versus nine days). © 2021 MJH Life Sciences and Applied Clinical Trials Online. In contrast to size/scope, there were no major differences in satisfaction between monitors and project managers in respect of level of detail. About 40% of management employees said that new or revised SOPs were often implemented unexpectedly and without "prior warning" by corporate headquarters. Study management Myth of the Vice-President ( research and Innovation ),,... Within companies that entailed adaptation of processes and responsibilities of respondents said existing SOPs were criticized for being unclear overloaded... Implement an effective quality management system with written SOPs. the amount of time required approximately! Which could be the reason for violations and dissatisfaction among those working with SOP proliferation is evident the... 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