Edmonton, AB, Canada T6G 2R3 Accelerating and Advancing Patient Care. ICH GCP, guidelines, 5.1.1, http://ichgcp.net/. Less than half of respondents (43%) said e-learning was the best method. Fifteen percent of companies check their employees' knowledge of the main SOPs at least once a year. In more than 80% of reported cases, a change in legislation was the reason for an SOP revision or creation of a new SOP. A two- to three-year cycle may be appropriate, but is not based on hard evidence. 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. "Details of a single process need to be searched for in multiple SOPs." 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 mean number of SOPs a study manager/project manager in clinical research had to be familiar with was approximately 50 SOPs/480 pages. Three-quarters of the surveyed monitors and project managers said they sometimes had to deviate from an SOP in their day-to-day work. R. Hattemer-Apostel, "Standard Operating Procedures—A Novel Perspective," Qual Assur J, 5 (4) 207–219 (2001). 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. Clinical Trial Agreement (CTA) with sponsors or contract research organisations (CROs') SOP. "Search features in the electronic SOP repository are ineffective." SOPs are intended to support compliance with laws and regulations that govern the conduct of clinical research. 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 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. W. Bohaychuk and G. Ball, "Standard Operating Procedures for Clinical Research Personnel—Part 23," Qual Assur J, 9 (1) 40–49 (2005). A. 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. Inspectors tend to attribute non-compliance with process descriptions to inadequate training. The VFA is an organization of 45 research-based pharmaceutical companies whose studies, between them, make up a significant portion of clinical trial activity in Germany. 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 vast majority was unable to identify SOPs that could be done without. Only a few articles looked into the complex regulatory environment of the pharmaceutical industry4 and the resulting principles of writing effective SOPs.5, 6. 6. 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 results hence reflect relevant experience of SOP systems in the pharmaceutical industry. There is also a plethora of different annexes such as flow charts, tables, job aids, completion guides, etc. 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 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 usually get applied in pharmaceutical processing and for related clinical studies. 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. ICH GCP section, 5.1.1, 5.4.1, http://ichgcp.net/. 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. Standard Operating Procedures for Clinical Trials (SOPs) Procurement Attendance Vehicle use •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) 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. The literature has comparatively little to say about what an optimal SOP system can and should look like. SOPs are designed to reflect 'how' a procedure is done, not 'why' it is done; the 'why' component is part of the training process. 5. You may edit and adapt for your department. However, this learning method lacks feedback on learning outcomes, which could be the reason for the lower acceptance among users. This guidance is another way to ensure that the researchers are complying with local and federal research regulations. 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. Nor is there any means of checking learning intensity or identifying misunderstandings regarding content. In nine cases the company was the local affiliate of a global corporation. 4 . 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). 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. Standard Operating Procedures. University of Alberta 116 St. and 85 Ave., Analysis of frequency of training and refresher cycles indicates that "not forgetting" is the primary element addressed. There are still acceptance problems among users nonetheless, in particular if the training provides no means of checking learning outcomes. As a member of N2, the University has access to a set of fully vetted SOPs. We are located on Treaty 6 / Métis Territory. This will greatly facilitate distribution, adoption and maintenance of one standard. SOPS need to reflect the regulations and guidance documents that govern clinical research and do NOT need to be site/institution specific. 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. Interactions with IEC (Institutional Ethics Committee) SOP. Even more respondents (88%), however, said face-to-face training was the best learning method. Creating SOPs for the clinical research staff provides written guidance and train - ing for investigator and staff. It is not necessary to document every service you provide. 8. 7. Training with formal review of learning outcomes accounted only for a median of 7.5% of training events. Involvement in SOP compilation did however not correlate with level of satisfaction. The answer was approximately nine days, again with significant variation. Seventy five percent of employees also said self-study was one of the most important ways of learning SOPs. What works for one company need not be the best solution for another. They are available to all University research teams and can be found here. 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. It should be noted that the SOPs contain minimal text copied from regulations and explanations of why procedures are done. To get around this problem, 70% of companies draw up local supplements. 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. SOP compilation and SOP quality. The starting point for this survey was the impression that employees are relatively dissatisfied with their SOP systems. The associated need for additional material on local processes was seen to result in unreasonable multiplication of process descriptions. 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. None had a reduction in the past 12 months. According to the respondents, corporate headquarters are responsible for SOP authorship in 60% of the surveyed companies. Half of the companies' management staff surveyed saw little or no potential for reductions (two SOPs on average). Instead, SOPs were criticized for being unclear and/or overloaded with abbreviations and jargon. Monitors and project managers were asked which quantity of training they would consider to be the most appropriate. LIST OF ABBREVIATIONS. Comprehensibility/clarity of SOPs. This seems to be more of a hindrance than a help in their daily work. 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. Responses in this survey were obtained from several companies who belong to the leading pharmaceutical companies in Europe. AE . 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. MCW Cancer Center SOPs for Research Staff . 1. 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 … Analysis of the survey shows that the quantity and variability of process descriptions does not seem to correlate with employee satisfaction with the SOP system. Nancy Paris elevates cancer treatment and research in Georgia Nancy Paris … 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.). 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. 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. 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. Two-thirds of the companies surveyed said learning SOP content was primarily the job of the individuals concerned. Specifications hence need to be developed independently. Policies & SOPS Clinical research is a rapidly growing and evolving field in healthcare. Interestingly, online training programs with options to review learning outcomes have significantly higher acceptance rates than those without. The expertise of SOP authors was largely rated favorably; only 10% of respondents said SOP authors tended to be far removed from reality. 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 … The former bears the risk of heterogeneous implementations. Almost half of the respondents reported little or no personal involvement in the creation of SOPs. 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 SOP cycle and change management. 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. Authors of SOPs tread a thin line in general, because user expectations and needs are as diverse as the spectrum of SOPs in existence. 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. ICH GCP section 5.1.1 merely states that sponsors are obliged to implement an effective quality management system with written SOPs. 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. 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. SOPs should be easy to search and according to simple process maps. SOPs for the Conduct of Clinical Research * Templates are optional tools that can be used or revised per departmental procedures. 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. 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. SOP 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 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. CRC SOP-03 Audits and Inspections. Few ways of streamlining processes or eliminating SOPs showed up. Survey appraises the use of SOPs in clinical research from the sponsors' point of view. SOPs should be user friendly, as short as possible, and as detailed as needed for clarity. is very important and widespread. Project managers tended to find them even more restrictive than monitors. Nonetheless, formal learning was deemed the best method of learning (80% of companies that said this was mostly or occasionally the case). The same applied for satisfaction in relation to time spent working in the company. About 40% of management employees said that new or revised SOPs were often implemented unexpectedly and without "prior warning" by corporate headquarters. Clinical trial agreement log. This extends to detailed specification of formats for templates/forms. 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. Both training providers and recipients recognize the responsibilities of employees in the learning process. Dieter Baier, PhD, is General Secretary of Medical and Scientific Excellence at Roche Pharma AG. The results of this survey indicate that the use of this method has become rather rare. 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.”. A template for Standard Operating Procedures (SOPs) for Clinical Research at Health Sciences Centre is available through the Health Trials office. In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc.) An SOP is a written process of how tasks are completed and who is responsible. A similar situation applied (almost 90%) with respect to structural changes within companies that entailed adaptation of processes and responsibilities. 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). However, self-study is nonetheless essential as a basis for learning. SOP length/level of detail. At least eight weeks is suggested. It is for this reason that the SOPs you will receive appear as print only PDF documents. B. Jones, "Principles in Quality Assurance," Qual Assur J, 6 (4) 219–225 (2002). About 30% put national laws ahead of company instructions and implement this policy without any formal modification/amendment of the global SOP. 2019 SOPs in Clinical Research SOP benchmarking project. Below are some of the commonly referenced SOPs used in the Clinical Research Center. One-third do not regularly check competency, 15% only in isolated cases, if the manager notices deficits or an audit identifies any deficiency. Cooperation with CROs. Estimation/user satisfaction with the currently established SOP system. More than 70% of the surveyed companies involve the line departments and about 50% involve quality assurance in SOP compilation. 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. "Sometimes it is not easy to find the right SOP you need for a particular process.". This list is not all-inclusive. Clinical project managers, monitors and assistants in the pharmaceutical industry involved in conducting clinical trials are experiencing increasing regulation. The global and/or local SOP systems for conducting trials that exist alongside legislative requirements differ greatly between companies. 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. SOP training. 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). Deviations resulting from a discrepancy between global SOPs and local legislation are handled in different ways. Not every SOP system is the same, and not every SOP is equally suitable for every organization. Clinical research and practice. 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. Complexity or novelty of processes and availability of complementary training modalities are key factors in constructing a flexible training system. There was a trend for a negative rating of all the sub-elements of scope/size, level of detail, comprehensibility, clarity, usefulness, and restrictiveness from employees who were dissatisfied with the SOP system overall. 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. The survey results also clearly show that training measures should not be analyzed in isolation from their particular context. may require unique approaches to specific clinical … Thus, the decision on depth of regulation is a task of the company. 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. The various aspects are looked at in greater depth in the following: Acceptance. 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. http://www.epa.gov/quality/qs-docs/g6-final.pdf. Twenty five percent of respondents said existing SOPs were not coherent and comprehensive. The drawback of this learning modality is the comparatively high cost. Office of the Vice-President (Research and Innovation), Regulations, Guidelines & University Policies. There seems to be high congruence between providers and recipients of training with regard to the amount of time required. Street Address 207 Schwartz Center, 800 E. Summit St., Kent, OH 44242-0001 Mailing Address 800 E. Summit St. Kent, OH 44242 It is strongly recommended that only one set of SOPs and related documents be used. There may be several conditions under which companies increase the depth of regulation. 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. If you feel that an SOP is not a reflection of your process, you may create an addendum the SOP. Are SOPs more restrictive than the legislative framework? 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). N2 SOPs (V.8, May 2019) are available to University of Alberta researchers conducting biomedical and clinical research. In this survey, face-to-face/classroom training had the highest level of acceptance. 2. It does identify potential for improvement in this area of such importance for the quality of clinical trials. About two-thirds of respondents said internal company SOP systems were more restrictive than applicable law. Very few respondents made specific proposals for SOPs that could actually be done without. Training units are repeated every one to two years in 56% of companies, and at intervals longer than two years in another third. CRC SOP-04 Case Report Forms. 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