sops for clinical research
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. "Search features in the electronic SOP repository are ineffective." These SOPs are used by the six UBC-affiliated Research Ethics Boards and are administered by the Office of Research Ethics. 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. 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. University of Alberta 116 St. and 85 Ave.. We are located on Treaty 6 / Métis Territory. In contrast to size/scope, there were no major differences in satisfaction between monitors and project managers in respect of level of detail. 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 addressees were management and organizational employees (e.g., medical directors, directors of clinical investigation, and quality assurance directors). Less than half of respondents (43%) said e-learning was the best method. Nor did the survey results confirm the often cited suspected widespread overregulation of SOP systems. University of Alberta 116 St. and 85 Ave., Training of all parties involved in the process is indisputably a key responsibility of sponsors. Questionnaire 2 was addressed at clinical research employees (i.e., monitors and project managers of the sponsor and freelancers/employees of CROs involved/in sourced by the sponsor for study projects). 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". Affiliates and subsidiaries are involved in the generation of global SOPs in addition to corporate headquarters. SOPs are intended to support compliance with laws and regulations that govern the conduct of clinical research. The starting point for this survey was the impression that employees are relatively dissatisfied with their SOP systems. 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. Complexity or novelty of processes and availability of complementary training modalities are key factors in constructing a flexible training system. Clinical Research Policies and SOPs Joint GU/MHRI Policies and Procedures. An average of 11 days per year is devoted to training, but this figure varied significantly among the respondents (Figure 2). 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. About 30% put national laws ahead of company instructions and implement this policy without any formal modification/amendment of the global SOP. A high level of regulation also carries the risk of making more mistakes and unintentionally violating an SOP. 5. Inspectors tend to attribute non-compliance with process descriptions to inadequate training. Responsibility, workflow, and personal accountability should be clearly defined in an SOP. Seventy five percent of employees also said self-study was one of the most important ways of learning SOPs. Globally operating companies face the challenge of implementing global policies into local practice in a way that accommodates local legal requirements and best practice but at the same time does not violate global SOPs. SOPs are designed to reflect 'how' a procedure is done, not 'why' it is done; the 'why' component is part of the training process. 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. Three to four responses per company were received from the employees invited to take part in the survey in the operative line departments (67 total); the majority were company project managers and/or clinical monitors with an average of 10 years of job experience. There seems to be high congruence between providers and recipients of training with regard to the amount of time required. The subjective feeling of many respondents seems to be that "less is more. 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. "Details of a single process need to be searched for in multiple SOPs." In most companies, the existing SOP systems fully cover regulatory needs. At least eight weeks is suggested. Few ways of streamlining processes or eliminating SOPs showed up. standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, … The former bears the risk of heterogeneous implementations. Almost half of the respondents reported little or no personal involvement in the creation of SOPs. SOPs should be user friendly, as short as possible, and as detailed as needed for clarity. Existing SOP systems in clinical research. W. Bohaychuk and G. Ball, "Standard Operating Procedures for Clinical Research Personnel—Part 23," Qual Assur J, 9 (1) 40–49 (2005). The associated need for additional material on local processes was seen to result in unreasonable multiplication of process descriptions. Only 27% of respondents were happy with system size/scope and less than half (48%) were happy with the level of detail. © In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) SOPs are described overall as too lengthy. Clinical trial agreement log. About two-thirds of respondents said internal company SOP systems were more restrictive than applicable law. 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. Our procedures have been developed according to the specific work groups within ECTU. 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. If you feel that an SOP is not a reflection of your process, you may create an addendum the SOP. Three-quarters of the surveyed monitors and project managers said they sometimes had to deviate from an SOP in their day-to-day work. 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. 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. Only a few marginal areas/exceptions were mentioned which still have to be covered by SOPs in individual companies. 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. About 45% of employees said they never deviated from an SOP. It is strongly recommended that only one set of SOPs and related documents be used. SOPS need to reflect the regulations and guidance documents that govern clinical research and do NOT need to be site/institution specific. In addition to regular review of SOPs at intervals of two to three years, there are other important reasons for revision. They improve quality of data collected and improves research, Provide a reference and guideline for conducting research, and Comprehensibility/clarity of SOPs. It should be noted that the SOPs contain minimal text copied from regulations and explanations of why procedures are done. The vast majority was unable to identify SOPs that could be done without. This will greatly facilitate distribution, adoption and maintenance of one standard. 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. It is not necessary to document every service you provide. For various reasons, in the case of inspection requirements, companies tend to set down processes in the greatest of detail and meticulously define every single step. The drawback of this learning modality is the comparatively high cost. The result is that local employees may find the global SOP to be inadequate and may encounter local situations that are not sufficiently addressed in global SOPs. Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. 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. 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. 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. 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. 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." This guidance is another way to ensure that the researchers are complying with local and federal research regulations. More than 70% of the surveyed companies involve the line departments and about 50% involve quality assurance in SOP compilation. Description of project/survey conduct. is very important and widespread. SOP cycle and change management. 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. 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. Here is a simple example of … Fifteen percent of companies check their employees' knowledge of the main SOPs at least once a year. 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). 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. One-third do not regularly check competency, 15% only in isolated cases, if the manager notices deficits or an audit identifies any deficiency. In this survey, face-to-face/classroom training had the highest level of acceptance. 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 … Whether and how subjective dissatisfaction in recent years correlates with SOP proliferation is evident from the following statements from management staff. Are SOPs more restrictive than the legislative framework? R. Hattemer-Apostel, "Standard Operating Procedures—A Novel Perspective," Qual Assur J, 5 (4) 207–219 (2001). Online training, on the other hand, evidently seems to have become widespread. SOP management. 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. Thirty five percent of respondents said the SOPs were not clearly structured, monitors more so than project managers. 2019 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.). The various aspects are looked at in greater depth in the following: Acceptance. MCW Cancer Center SOPs for Research Staff . Twenty five percent of respondents said existing SOPs were not coherent and comprehensive. A. 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. 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. To get around this problem, 70% of companies draw up local supplements. Even more respondents (88%), however, said face-to-face training was the best learning method. http://www.epa.gov/quality/qs-docs/g6-final.pdf. Conversely, gap analysis revealed little or no need to extend the SOP system. Nancy Paris elevates cancer treatment and research in Georgia Nancy Paris … Study team members need to understand the 'why' concepts in order to be deemed suitably trained to perform these procedures. The goal was to develop one set of well-written SOPs that would cross all therapeutic areas in any given institution or research environment. A. Blackmore, "The Myth of the SOP," Qual Assur J 8 (1) 3–12 (2004). 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. To name just a few, the terms employed include SOP, policy, operating instruction, and working instruction. As already mentioned at the outset, existing regulations do not dictate the depth of regulation in SOPs. 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.”. 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. A two- to three-year cycle may be appropriate, but is not based on hard evidence. The global and/or local SOP systems for conducting trials that exist alongside legislative requirements differ greatly between companies. SOPs - Any - Administration Clinical Research Governance and Sponsorship Human Resources Monitoring Quality Assurance Safety Reporting Use the dropdown to search for dowloadable SOP … ", Many respondents cited the difficulty in finding individual process steps within an SOP system as being a key problem. The needs of career starters differ from those of employees who have worked in the company or in clinical research for longer. 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. Cooperation with CROs. SOP should address certain groups of users and contain only information relevant for those. In case global SOPs do interfere with local regulatory requirements, the latter prevail. SOPs for the Conduct of Clinical Research * Templates are optional tools that can be used or revised per departmental procedures. We are located on Treaty 6 / Métis Territory. SOPs should be oriented to a process and not to specific functions. Authors of SOPs tread a thin line in general, because user expectations and needs are as diverse as the spectrum of SOPs in existence. Standard Operating Procedures. About 50% of companies draw up local modifications. Increase and overregulation of processes—potential for reductions. 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. M. Spitzer, "Born to Learn," Journal for International Perspectives, 4 (2004). 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. Survey appraises the use of SOPs in clinical research from the sponsors' point of view. 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 mean number of SOPs a study manager/project manager in clinical research had to be familiar with was approximately 50 SOPs/480 pages. It is important in this context to accommodate different learning types and availability of the insights of experts in the psychology of learning.8 A flexible learning system with a variety of learning modalities should be offered. About 40% said there had been no change regarding the estimated number of global or local SOPs. We have developed several Standard Operating Procedures and Working Practice Documents to support the running of trials within the unit and to ensure compliance with the principles of Good Clinical Practice (GCP). Nor is there any means of checking learning intensity or identifying misunderstandings regarding content. "Sometimes it is not easy to find the right SOP you need for a particular process.". Instead, SOPs were criticized for being unclear and/or overloaded with abbreviations and jargon. In nine cases the company was the local affiliate of a global corporation. SOP compilation and SOP quality. Creating SOPs for the clinical research staff provides written guidance and train - ing for investigator and staff. 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. Two-thirds of the companies surveyed said learning SOP content was primarily the job of the individuals concerned. Are SOPs useful in your daily work? 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. About 40% of management employees said that new or revised SOPs were often implemented unexpectedly and without "prior warning" by corporate headquarters. 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. 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. Nonetheless, formal learning was deemed the best method of learning (80% of companies that said this was mostly or occasionally the case). Adverse Event (same as Adverse Drug Experience, Adverse Experience, Adverse Drug Reaction, Adverse Reaction) CHNw . Only a few articles looked into the complex regulatory environment of the pharmaceutical industry4 and the resulting principles of writing effective SOPs.5, 6. Level of satisfaction management and organizational employees ( e.g., medical directors directors! Criticized for being unclear and/or overloaded with abbreviations and jargon and operational aspects clinical! Expressed by project managers than by monitors or post-hoc documented violations nine days, again with significant.. 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