Good Clinical Practice Training Research Articles

A Brief Review on Good Clinical Practice and its Training Methods

Abstract The field of clinical research continues to advance, and for ethical conduct of research, researchers need to have a strong foundation in good clinical practice (GCP). GCP guidelines are internationally recognized standards that govern the conduct of clinical trials, ensuring the protection of human subjects and the generation of reliable data. However, novice researchers or postgraduate medical students who would delve into research activities may face difficulty getting avenues for GCP training. Hence, in this brief review article, we discuss the significance of GCP in the field of clinical research with a glimpse of its history, development, and key principles. We provide a list of online courses, benefits, and disadvantages of those courses, and a list of organizations that conduct GCP workshops or continued medical education programs in India.

159 Good Clinical Practice training assignment and tracking completions improvement project

OBJECTIVES/GOALS: We will reduce the number of research staff by 50% within 6 months that are non-compliant with completing the Good Clinical Practice (GCP) course without increasing costs as measured by salary and benefits for staff involved in the tracking and assignment process. We will also introduce a GCP policy to define the education requirements for GCP training METHODS/STUDY POPULATION: We touted focus groups to stakeholders for input on workflows with graphs, surveys, and meetings in the onset and throughout the project. This input prompted us to develop a staff guide outlining the modification process of removing a staff name from an IRB trial if they are no longer active in the trial. A workflow and root cause analysis were done resulting in the implementation of one gatekeeper for assigning and tracking completions, instead of three staff. Successfully reconciling the non-compliant report, which extracted data from three databases, allowed us to eliminate 174 names from the report, which originally comprised 792 names. IRB modifications were entered into the IRB system for these 174 names. We also put into effect a GCP policy for the institution, where none had previously existed. RESULTS/ANTICIPATED RESULTS: * In 3.5 months, we decreased the GCP non-compliance rate by 50% from 792 to 399. * We removed 22% of names from the 792 from the report due to their status of being non-employees, or Emeritus, or not in research anymore. * We discovered a data type issue in the non-compliance report that shuffled the MAX calculation, therefore not requiring some staff to complete the training. * We developed a new process for assigning training, resulting in faster compliance rates for the institution. It included sending emails to users two months before their training expired before we assigned the course to them. * We reconciled the non-compliance report, and it decreased the effort with staff involved in GCP for grant renewals and audits in numerous other departments. * Developed an escalation procedure for non-compliant staff. DISCUSSION/SIGNIFICANCE: Failure to address our GCP non-compliance rates could have put our institution at risk for potential penalties. With 4400+ research personnel listed on active trials the interventions we implemented accelerated our compliance rate by assigning the refresher course monthly and this also resulted in no disruption to staff completing the training.

Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians

BackgroundStatisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international quality standard for the conduct of clinical trials research. Statisticians are required to undertake training on GCP but existing training is generic and, crucially, does not cover statistical activities. This results in statisticians undertaking training mostly unrelated to their role and variation in awareness and implementation of relevant regulatory requirements with regards to statistical conduct. The need for role-relevant training is recognised by the UK NHS Health Research Authority and the Medicines and Healthcare products Regulatory Agency (MHRA).MethodsThe Good Statistical Practice (GCP for Statisticians) project was instigated by the UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) Statisticians Operational Group and funded by the National Institute for Health and Care Research (NIHR), to develop materials to enable role-specific GCP training tailored to statisticians. Review of current GCP training was undertaken by survey. Development of training materials were based on MHRA GCP. Critical review and piloting was conducted with UKCRC CTU and NIHR researchers with comment from MHRA. Final review was conducted through the UKCRC CTU Statistics group.ResultsThe survey confirmed the need and desire for the development of dedicated GCP training for statisticians. An accessible, comprehensive, piloted training package was developed tailored to statisticians working in clinical research, particularly the clinical trials arena. The training materials cover legislation and guidance for best practice across all clinical trial processes with statistical involvement, including exercises and real-life scenarios to bridge the gap between theory and practice. Comprehensive feedback was incorporated. The training materials are freely available for national and international adoption.ConclusionAll research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders.

The development and acceptability of an educational and training intervention for recruiters to neonatal trials: the TRAIN project

BackgroundSuboptimal or slow recruitment affects 30–50% of trials. Education and training of trial recruiters has been identified as one strategy for potentially boosting recruitment to randomised controlled trials (hereafter referred to as trials). The Training tRial recruiters, An educational INtervention (TRAIN) project was established to develop and assess the acceptability of an education and training intervention for recruiters to neonatal trials. In this paper, we report the development and acceptability of TRAIN.MethodsTRAIN involved three sequential phases, with each phase contributing information to the subsequent phase(s). These phases were 1) evidence synthesis (systematic review of the effectiveness of training interventions and a content analysis of the format, content, and delivery of identified interventions), 2) intervention development using a Partnership (co-design/co-creation) approach, and 3) intervention acceptability assessments with recruiters to neonatal trials.ResultsTRAIN, accompanied by a comprehensive intervention manual, has been designed for online or in-person delivery. TRAIN can be offered to recruiters before trial recruitment begins or as refresher sessions during a trial. The intervention consists of five core learning outcomes which are addressed across three core training units. These units are the trial protocol (Unit 1, 50 min, trial-specific), understanding randomisation (Unit 2, 5 min, trial-generic) and approaching and engaging with parents (Unit 3, 70 min, trial-generic). Eleven recruiters to neonatal trials registered to attend the acceptability assessment training workshops, although only four took part. All four positively valued the training Units and resources for increasing recruiter preparedness, knowledge, and confidence. More flexibility in how the training is facilitated, however, was noted (e.g., training divided across two workshops of shorter duration). Units 2 and 3 were considered beneficial to incorporate into Good Clinical Practice Training or as part of induction training for new staff joining neonatal units.ConclusionTRAIN offers a comprehensive co-produced training and education intervention for recruiters to neonatal trials. TRAIN was deemed acceptable, with minor modification, to neonatal trial recruiters. The small number of recruiters taking part in the acceptability assessment is a limitation. Scale-up of TRAIN with formal piloting and testing for effectiveness in a large cluster randomised trial is required.

Process evaluation in practice based research networks: a study protocol for a mixed-methods implementation study

IntroductionGeneral practitioners often criticise clinical trials for their poor applicability in primary care, which may at least partially explain why their engagement in primary care research remains limited. In order...

Developing skills of allied health professionals for a principal investigator role: A case from the SIP SMART2 swallowing prehabilitation trial

BACKGROUND: Clinicals trials are the bedrock for evidence-based practice amongst healthcare professionals. Creating research opportunities through structured training is integral in developing future research leaders including allied health professionals (AHP)s. The UK National Institute for Health Research (NIHR) Associate Principal Investigator (Associate PI) scheme was launched in 2019 to support trainee medical, dental, nursing and AHPs to gain practical experience delivering clinical trials under local PIs. Associate PI certification requires completion of activities which includes Good Clinical Practice Training, attendance at trial meetings, trial recruitment and maintenance of site file related activities. The aim of this article was to showcase how the activities completed by an AHP undertaking the Associate PI scheme support researcher development. METHODS: SIP SMART2 is a multicentre trial of swallowing prehabilitation in head and neck cancer. SIP SMART2 was one of the first AHP-led trials to be registered on the Associate PI scheme in April 2019 with six Associate PIs registered. The example of one trainee’s activities and skills acquisition by completing the scheme were compared to a well-established researcher development framework known as the Vitae Researcher Development Framework (RDF). RESULTS: Activities completed during the Associate PI scheme supported development across all 4 domains of the RDF. In particular, Domain C (Research governance and organisation) and Domain D (Engagement, influence and impact). CONCLUSIONS: The Associate PI scheme provides an opportunity for AHPs to gain skills and experience to develop across all domains of the Vitae RDF. Future work should assess whether completion of the Associate PI scheme leads to long-term engagement in clinical research.

Efficacy and safety of carbon dioxide insufflation for brain protection for patients undergoing planned left-sided open heart valve surgery: protocol for a multicentre, placebo-controlled, blinded, randomised controlled trial (the CO2 Study)

IntroductionBrain injury is common following open heart valve surgery. Carbon dioxide insufflation (CDI) has been proposed to reduce the incidence of brain injury by reducing the number of air microemboli...

Abstract 1975: Community Engagement in Research and Clinical Trial (CERCT) program: The development of an inclusive clinical trials training program for community health workers (CHWs) and pharmacy technicians

Abstract Background: In the United States, many underrepresented minorities experience health disparities in preventative options, access to care, and participation in research. There remains a critical need for robust inclusiveness and diversity to achieve comprehensive participation in research and true health equity. Community health workers (CHWs) and pharmacy technicians may be an overlooked segment in increasing the community reach necessary in alleviating health disparities. Training individuals from and trusted by the community to educate and discuss the importance of research participation may prove an important community engagement method for achieving diversity in clinical trials. Aim: This Community Engagement in Research and Clinical Trial (CERCT) program aims to develop a training curriculum on clinical trials education and inclusivity in research for CHWs and pharmacy technicians. Methods: The CERCT program utilized qualitative methodology in expert in-depth interview sessions with clinical trials and education experts. An appropriate curriculum, content, and mode of training delivery for the program were identified. Interviews also critically reviewed the scientific information most crucial to disseminate to CHWs and Pharmacist technicians, defined the criteria for selecting the most appropriate scientific information for this level of community health partners, and characterized editorial and media management of the training modules. Results: Eleven CERCT modules were developed comprising the importance and benefits of taking part in research and biomedical trials and how to communicate it to others. Modules included 1) history of clinical trials, including past overreach and the need for biomedical research with humans; 2) human participant research studies education, including qualitative and quantitative components; 3) the difference between behavioral, biomedical, and clinical trials; 4) CHW roles in education of research participation, 5) effective communication strategies, 6) research ethics, 7) human subject protection training, 8) the role of the institutional review board, 9) eligibility to consent, 10) vulnerable populations, and 11) Good Clinical Practice training. Conclusion: Community health workers and pharmacy technicians are not a consistent avenue for disseminating clinical trial education and research inclusivity benefits. The development of a curriculum aimed at CHWs and pharmacy technicians seeks to empower more community members with the education to inform their communities and increase representation in science. By creatively engaging and educating active community partners about clinical trials, health disparities in chronic diseases such as cancer, may be alleviated. Citation Format: Jennifer M. Crook, Opeyemi Bolajoko, Folakemi Odedina. Community Engagement in Research and Clinical Trial (CERCT) program: The development of an inclusive clinical trials training program for community health workers (CHWs) and pharmacy technicians [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1975.

“How do I keep this live in my mind?” Allied Health Professionals’ perspectives of barriers and enablers to implementing good clinical practice principles in research: a qualitative exploration

BackgroundAllied health professionals (AHPs) engaged in research are expected to comply with Good Clinical Practice (GCP) principles to protect participant safety and wellbeing and enhance data integrity. Currently, few studies have explored health professionals’ perceptions of implementing and adhering to GCP principles in research with none of these including AHPs. Such knowledge is vital to guide future interventions to increase adherence to GCP principles. This study aimed to identify the barriers and enablers AHPs experience when applying GCP principles to research conduct in a public hospital and health service, as well as their perceived support needs.MethodsThe study used a qualitative descriptive study approach guided by behaviour change theory. AHPs currently undertaking ethically approved research within a public health service in Queensland, Australia were interviewed to explore barriers and enablers to adherence to GCP principles and support needs, with interview questions guided by the Theoretical Domains Framework (TDF). The TDF was chosen as it allows for a systematic understanding of factors influencing implementation of a specific behaviour (i.e., GCP implementation) and can be used to inform tailored interventions.ResultsTen AHPs across six professions were interviewed. Participants identified both enablers and barriers to implementing GCP across nine domains of the TDF and enablers across three additional domains. Examples of enablers included strong beliefs about the importance of GCP in increasing research rigour and participant safety (i.e. from TDF - beliefs about consequences); applying clinical skills and personal attributes when implementing GCP (i.e., skills), available training and support (i.e., environmental context and resources); and alignment with their moral sense to ‘do the right thing’ (i.e., professional identity). Barriers to GCP implementation were generally less commonly reported but included reduced time to implement GCP and a sense of ‘red tape’ (i.e., environmental context and resources), a lack of knowledge of GCP principles (i.e., knowledge) and a fear of making mistakes (i.e., emotions), and varying relevance to individual projects (i.e., knowledge). Suggestions for support were identified beyond training, such as physical resources (e.g., prescriptive checklists, templates and scripts), additional time, and regular one-on-one mentoring support.ConclusionFindings suggest that while clinicians recognise the importance of GCP and want to implement it, they report barriers to its practical implementation. GCP training alone is unlikely to address these barriers to implementing GCP in daily practice. Findings suggest that GCP training may be more useful to AHPs when it is tailored to the allied heath context and supplemented with additional supports including check-ups from experienced researchers and access to prescriptive resources. Future research however is needed to investigate the effectiveness of such strategies.

4339 Exploring Physician Investigator Clinical Trials Training and Quality Management Systems and its Implementation in Medical School Curriculums

OBJECTIVES/GOALS: Although many physicians conduct clinical trials as Principle Investigators, a systematic training is often lacking. Instead, most receive on-site training, potentially compromising data quality and human subject safety. This research assesses the landscape for physician training through medical school curriculums. METHODS/STUDY POPULATION: This project explored training programs for physician researchers, specifically in the emerging field of quality management systems (QMS). To understand the scope of academic research available for QMS and Good Clinical Practice (GCP) training and lack of clinical trial training implemented in medical school curricula, a literature review was conducted. Available training for physicians was assessed through existing training programs from the FDA, NIH, DIAMOND, ACRP, and Google for accessibility in terms of costs, completion timelines and certification, format (online vs. in-person), and inclusion of GCP and QMS training in the curriculum RESULTS/ANTICIPATED RESULTS: Literature review revealed that not much is known about physician researcher training beyond the institutional requirement for minimal GCP review. Examination of select medical school curriculum also discovered a lack of clinical trial training for students interested in clinical research. Furthermore, existing training programs and modules available for physicians are limited as their syllabi do not include QMS training. In addition, these programs commonly have inaccessible registration links, are expensive, and have significant time commitments for in-person courses. These findings support the need for more accessible and effective training and certification tools for physician researchers. DISCUSSION/SIGNIFICANCE OF IMPACT : QMS training is not included medical school curricula or programs for physician researchers, potentially compromising data integrity and subject protection. This research supports the development of essential QMS training concepts and practical approaches for physician researcher clinical trials.

4507 Developing and implementing a Principal Investigator (PI) primer to improve the conduct of human research at the University of Minnesota

OBJECTIVES/GOALS: 1.Assess the institutional and individual training needs and gaps in the conduct of human research for PIs at the University of Minnesota.2.Define the training program’s learning objectives.3.Develop and implement an in-person training session that addresses the gaps.METHODS/STUDY POPULATION: Establish a planning committeeIdentify required and optional training that is already available for PIs, then determine gapsUnderstand research training needs based on conversations with departmental and human research protection program leaders.Develop learning objectives and curriculum based on Federal and Local regulations, guidelines, and policies.Establish a feedback loop regarding research compliance with the HRPP, to assess trends and ensure continuous improvement.Evaluate the training program’s participants using confidence and satisfaction measures.RESULTS/ANTICIPATED RESULTS: Developed and piloted a 90-minute in-person training program entitled “PI Primer” with the goals of: Increasing awareness and knowledge of the role and responsibilities of the Principal Investigator (PIs) according to the International Harmonization for Good Clinical Practice (ICH-GCP), Federal Regulations (FDA, DHHS, ect.), and University of Minnesota Policies.Identifying root causes for receiving an FDA 483 (inspection findings).Addressing and preventing common inspection findings (CAPA).Describe individual and institutional conflict of interest (COI), and identify the key steps necessary to manage COIs.DISCUSSION/SIGNIFICANCE OF IMPACT: OHRP’s guidance on the “Responsibilities of Investigators” states that it is the Institution’s responsibility to provide human research training on a wide variety of topics to ensure the ethical conduct of research and protection of participants. PI Primer provides an in-person forum for investigators to build upon required responsible conduct of research and good clinical practice training to be able to apply the role and responsibilities of a PI to their own research. PI Primer also establishes a network of PIs in order to enhance connectivity and shared learning.

SUN-075 A Guide to Professional Development: Funding Your Research Through NICHD

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) leads research and training efforts to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. Under the “New Strategic Plan 2020”, NICHD will focus on priorities to: 1. Understand the Molecular, Cellular, and Structural Basis of Development; 2. Promote Gynecologic, Andrologic, and Reproductive Health; 3. Set the Foundation for Healthy Pregnancies and Lifelong Wellness; 4. Improve Child and Adolescent Health and the Transition to Adulthood; and 5. Advance Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities. Cross-cutting topics include health disparities, prevention, infectious disease, nutrition and global health. NICHD is committed to funding the largest number of meritorious projects, while allowing flexibility to support high program priorities and respond to emerging scientific opportunities. Mechanisms to support individual research and training include research project grants (RPGs), training and career development awards (K awards) and fellowships (Pre and Postdoctoral). There are specific eligibility requirements for each of these mechanisms. Applicants are advised to contact a program officer (PO) and discuss the idea, its relevance to program priorities of NICHD, and potential funding opportunities available. While preparing your application, receive guidance on the grantsmanship from the PO, in addition to peers working at your institution. The PO can help you to understand the peer review process at NIH and suggest study sections with a good fit to review your application. The peer review process is independent of the program administration at NIH. Applicants can avoid some common errors in writing applications by reviewing the NIH website and understanding the NIH grants process. The NIH has recently revised its approach to the review and monitoring of vertebrate animal and human subject research. Applicants may receive guidance both at their institution (from which the application is submitted) and NIH. NICHD has developed new guidelines and processes to enhance and improve clinical trials. Currently, applications may be submitted to separate funding opportunity announcements for “clinical trials required” and “clinical trials optional”. The goal is to ensure adequate clinical trial-specific information in the grant applications for thorough review. Additional new review criteria consider training in good clinical practice and expanded registration and results reporting in ClinicalTrials.gov.

Public Health Crises and the Human Subjects of Biomedical Research: A Focus on COVID-19

Public Health Crises and the Human Subjects of Biomedical Research: A Focus on COVID-19

Enquête sur la certification aux bonnes pratiques cliniques en recherche académique

Good clinical practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials. Before the start of a clinical trial, investigators commit to perform the research in accordance with GCPs, regulatory dispositions and protocol. The sponsors are responsible for investigators' selection and for controlling their skills. Whereas industrial sponsors systematically require a certificate of GCP training, academic sponsors seem to be less demanding. We have carried out two surveys between April and June 2018. A first questionnaire was sent to the 40 French academic directions of clinical research and innovation in order to determine their requirements about the GCP training of the investigators participating in their trials. The second questionnaire was transmitted to physicians of the "Bretagne recherche clinique hospitalière network": Rennes, Saint-Malo, Saint-Brieuc, Vannes, Lorient and Pontivy hospitals, in order to determine the GCP certification rate, and their needs in terms of clinical research training. Twenty-eight (70%) directions of clinical research answered the first survey, among which 18 (64%) required systematically the investigators' GCP certification in case of category 1 interventional studies. This rate decreased for category 2 (50%) and non-interventional category 3 (18%) studies. A total of 345 physicians answered the second survey, among which 263 (76%) had already been clinical trial investigators. However, only 29% of all physicians and 54% of those who had been principal investigator were certified for GCP training. These results support the need for large campaigns of GCP training in public hospitals.

Improved infrastructure and support needed for paediatric clinical trials in Sweden.

There is a lack of authorised medicines for paediatric patients and improved drug development is necessary. The aim of this study was to evaluate the need for infrastructure and support for paediatric clinical trials in Sweden. A web-based survey was sent to doctors and nurses involved in the care of neonates, children and adolescents assessing the current situation and future needs for paediatric clinical trials in Sweden. Questions regarding premises, competence, organisation, support for paediatric clinical trials and Good Clinical Practice Training were addressed. In total, 137 individuals responded to the survey (109 doctors and 28 nurses). Overall, 61% of the respondents had previous experience of paediatric clinical trials. Some respondents had access to trial units, but only 34% had used the trial unit for support. Half of the responders were interested in recurrent paediatric Good Clinical Practice training. Doctors responded that clinical work often had to be prioritised and emphasised the need for research time. This study clearly shows the commitment for clinical trials among doctors and nurses involved in paediatric care in Sweden, but also that administrative, logistic and economic support in a sustainable setting and an expanded national collaboration are needed.

Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study.

This paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability (α = 0.69). It is a valid and reliable instrument for measuring knowledge of GCP. The test will be useful in assessing the effectiveness of GCP training programs as well as individuals' mastery of GCP content.

How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge

Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health-funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal-numerical reasoning and learning orientation. During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training-whether online or face to face-does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.

Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates

The Clinical Trials Transformation Initiative (CTTI) Investigator Qualification Project addresses the need for a more efficient and effective means of identifying qualified clinical investigators and delegates. Selection of investigators and delegates who are qualified by training and experience to conduct clinical trials is essential to safeguarding protections for study participants and ensuring data quality and integrity. Sponsors generally document investigator qualification through training on the principles of good clinical practice (GCP), as defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), adopted by regulatory authorities in the United States, Japan and the European Union. Although these GCP principles provide an important foundation for promoting the conduct of quality clinical trials, the industry standard “one-size-fits-all” GCP training may not fully prepare investigators and delegates for conducting quality clinical trials. Routine GCP training alone may not be sufficient to prepare an inexperienced member of a site team, while repeating such training is unlikely to enhance the qualifications of an experienced researcher. The CTTI project team used findings from qualitative research activities, as well as input from an expert meeting with multiple stakeholders, to identify gaps and redundancies in the current training of investigators and their delegates and recommend practical, action-based solutions. CTTI provides recommendations on how to implement a more efficient and effective means of preparedness and qualification of investigators and delegates, determining whether a site team is a good fit for a particular protocol, and improving the quality of clinical trial conduct.

Creating and testing a GCP game in an asynchronous course environment: The game and future plans.

The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform. The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions. Students were invited to participate in the GCP Kaizen game as part of their 100% online academic Masters during the Spring 2019 semester. The structure of the game consisted of 75 original multiple choice and 25 repeated questions stemming from fictitious vignettes that were distributed across 10 weeks. Each question presented a teachable rationale after the answers were submitted. At the end of the game, a satisfaction survey was issued to collect player satisfaction data on the game platform, content, experience as well as perceptions of GCP learning and future GCP concept application. There were 71 total players who participated and answered at least one question. Of those, 53 (75%) answered all 100 questions. The game had a high Cronbach's alpha, and item analyses provided information on question quality, thus assisting us in future quality edits before re-testing and wider dissemination. The GCP Kaizen game provides an alternative method for mandated GCP training using principles of gamification. It proved to be a reliable and an effective educational method with high player satisfaction.

Training and accreditation standards for pathologists undertaking clinical trial work.

Clinical trials rely on multidisciplinary teams for successful delivery. Pathologists should be involved in clinical trial design from the outset to ensure that protocols are optimised to deliver maximum data collection and translational research opportunities. Clinical trials must be performed according to the principles of Good Clinical Practice (GCP) and the trial sponsor has an obligation to ensure that all of the personnel involved in the trial have undergone training relevant to their role. Pathologists who are involved in the delivery of clinical trials are often required to undergo formal GCP training and may additionally undergo Good Clinical Laboratory Practice training if they are involved in the laboratory analysis of trials samples. Further training can be provided via trial‐specific investigator meetings, which may be either multidisciplinary or discipline‐specific events. Pathologists should also ensure that they undertake External Quality Assurance schemes relevant to the area of diagnostic practice required in the trial. The level of engagement of pathologists in academia and clinical trials research has declined in the United Kingdom over recent years. This paper recommends the optimal training and accreditation for pathologists undertaking clinical trials activities with the aim of facilitating increased engagement. Clinical trials training should ideally be provided to all pathologists through centrally organised educational events, with additional training provided to pathologists in training through local postgraduate teaching. Pathologists in training should also be strongly encouraged to undertake GCP training. It is hoped that these recommendations will increase the number of pathologists who take part in clinical trials research in order to ensure a high level and standard of data collection and to maximise the translational research opportunities.