ArticleTherapeutic innovation & regulatory science2016
Good Clinical Practice Training: Identifying Key Elements and Strategies for Increasing Training Efficiency.
Article in Therapeutic innovation & regulatory science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed.
- A study within a trial evaluating supplemental, reinforced risk-based training to reduce implementation barriers in a pediatric multicenter randomized controlled trial.Contemporary clinical trials · 2026Trial
- Integrating ICH Good Clinical Practice (GCP) Principles and Essential Documentation into Dermatology Residency Education in China.Advances in medical education and practice · 2025Article
- Prioritisation of clinical trial learning needs of musculoskeletal researchers: an inter-disciplinary modified Delphi study by the Australia & New Zealand musculoskeletal clinical trials network.BMC medical education · 2024Article
- Variability in research culture across busy catheterisation labs in the Asia-Pacific region.AsiaIntervention · 2024Article
- Toward a global harmonization of service infrastructure in academic clinical trial units: an international survey.Frontiers in medicine · 2023Article
- An exploratory study on needs for clinical research training: data from Chinese hospitals.BMC medical education · 2021Article
- More than a box to check: Research sponsor and clinical investigator perspectives on making GCP training relevant.Contemporary clinical trials communications · 2020Article
- Improving the quality conduct and efficiency of clinical trials with training: Recommendations for preparedness and qualification of investigators and delegates.Contemporary clinical trials · 2020Article
- Creating and testing a GCP game in an asynchronous course environment: The game and future plans.Journal of clinical and translational science · 2020Article
- Design, implementation, and evaluation of PINDAR, a novel short program on GCP for academic medical center principal investigators conducting human subject research.Journal of clinical and translational science · 2018Article
- Ready or not? Observations from a long-standing community engagement advisory board about investigator competencies for community-engaged research.Journal of clinical and translational science · 2018Article
- NIH Policies on Experimental Studies with Humans.Nature human behaviour · 2018Article
- Best practices in social and behavioral research: report from the Enhancing Clinical Research Professional's Training and Qualifications project.Journal of clinical and translational science · 2017Article
- A Brief Review on Good Clinical Practice and its Training Methods.Indian dermatology online journalReview
- Impact of educational intervention on knowledge and awareness of good clinical practice among healthcare professionals at a tertiary care teaching hospital.Perspectives in clinical researchArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
Abstract
Good Clinical Practice (GCP) is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. The goal of GCP is to ensure the protection of the rights, integrity, and confidentiality of clinical trial participants and to ensure the credibility and accuracy of data and reported results. In the United States, trial sponsors generally require investigators to complete GCP training prior to participating in each clinical trial to foster GCP and as a method to meet regulatory expectations (ie, sponsor's responsibility to select qualified investigators per 21 CFR 312.50 and 312.53(a) for drugs and biologics and 21 CFR 812.40 and 812.43(a) for medical devices). This training requirement is often extended to investigative site staff, as deemed relevant by the sponsor, institution, or investigator. Those who participate in multiple clinical trials are often required by sponsors to complete repeated GCP training, which is unnecessarily burdensome. The Clinical Trials Transformation Initiative convened a multidisciplinary project team involving partners from academia, industry, other researchers and research staff, and government to develop recommendations for streamlining current GCP training practices. Recommendations drafted by the project team, including the minimum key training elements, frequency, format, and evidence of training completion, were presented to a broad group of experts to foster discussion of the current issues and to seek consensus on proposed solutions.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.