ArticlePerspectives in clinical research
Assessment and classification of protocol deviations.
Article in Perspectives in clinical research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 12 registered trials, which are not on this map. Cited by 14 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.
A Multicentre, Open-label, Interventional, Pilot Trial to Assess the Performance and Tolerance of mRDX-02-17 Dermal Filler in the Facial Rejuvenation
Open, Non-comparative Study to Evaluate the Performance and Safety of the Medical Device AURALYA® (Hyaluronic Acid-dermal Filler) in the Treatment of Nasolabial Wrinkles to Obtain Facial Rejuvenation
Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device JANESSE® (Hyaluronic Acid-Dermal Filler) In The Correction Of Facial Wrinkles
Open, Non-Comparative Study To Evaluate The Performance And Safety Of The Medical Device Jalucomplex® (Hyaluronic Acid-Dermal Filler) In the Treatment Of Facial And Neck Wrinkles To Obtain Facial Rejuvanation
Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Plenhyage® (Polymerised Polynucleotides Dermal Filler) in the Treatment of Dermal Tissue Defects
Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Auralya® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects
Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Janesse® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial Dermal Tissue Defects
Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Jalucomplex® (Hyaluronic Acid-dermal Filler) in the Treatment of Facial and Neck Dermal Tissue Defects
Open, Non-comparative, Multicentre, Interventional Clinical Investigation to Evaluate the Performance and Safety of the Medical Device Ialuxid® Gel (Hydrogen Peroxide and Hyaluronic Acid) in the Treatment of Acne Vulgaris and Folliculitis.
Open, Non-comparative, Multicentre, Interventional Post-market Clinical Follow-up (PMCF) Study to Evaluate the Performance and Safety of the Medical Device Argogen® (adsorbing Spray Powder for Exudates with Silver Ions) in the Treatment of Pressure Ulcers and Minor (first and Second Degree) Burn Wounds
Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre, Interventional Clinical Trial to Assess the Efficacy and Safety of the Food Supplement Microsmin® Plus in the Symptomatic Treatment of Haemorrhoids
A Multicentre, Prospective, Open-label, Non-comparative Study to Evaluate Menstrual Bleeding Typology, Tolerability, and Compliance During a Monophasic Hormonal Contraceptive Treatment With Norgestimate + Ethinylestradiol in Italy.
Who cites it
14 citing papers in PubMed.
- A randomized pilot and feasibility trial of live and recorded music interventions for management of delirium symptoms in acute geriatric patients.BMC geriatrics · 2025Trial
- Protocol Deviations at an Academic Clinical Research Unit: Insights and Strategies for Prevention.Clinical and translational science · 2026Article
- Analysis of Serious Breach Cases Reported in the EU Clinical Trials Information System: Quantitative and Qualitative Assessment.Therapeutic innovation & regulatory science · 2026Article
- Gender medicine and the Cass Review: why medicine and the law make poor bedfellows.Archives of disease in childhood · 2025Review
- A review of reproducible and transparent research practices in urology publications from 2014 to2018.BMC urology · 2022Review
- Development of the CLARIFY (CheckList stAndardising the Reporting of Interventions For Yoga) guidelines: a Delphi study.BMJ open · 2022Article
- Review
- Clinical implementation of deep learning contour autosegmentation for prostate radiotherapy.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2021Article
- Text Classification for Clinical Trial Operations: Evaluation and Comparison of Natural Language Processing Techniques.Therapeutic innovation & regulatory science · 2021Review
- Ten simple rules for providing effective bioinformatics research support.PLoS computational biology · 2020Article
- Improving the Quality of Provided Care: Lessons Learned From Auditing Neonatal Stabilization.Frontiers in pediatrics · 2020Article
- Quality Management in Clinical and Public Health Research: A Panacea for Minimising and Eliminating Protocol Deviations in Research Operations.Nigerian medical journal : journal of the Nigeria Medical AssociationArticle
- Impact of protocol deviations on the clinical study.Perspectives in clinical researchArticle
- Unreported protocol deviations - The tip of the research-berg.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
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDeviations from the approved trial protocol are common during clinical trials. They have been conventionally classified as deviations or violations, depending on their impact on the trial.
methodsA new method has been proposed by which deviations are classified in five grades from 1 to 5. A deviation of Grade 1 has no impact on the subjects' well-being or on the quality of data. At the maximum, a deviation Grade 5 leads to the death of the subject. This method of classification was applied to deviations noted in the center over the last 3 years.
resultsIt was observed that most deviations were of Grades 1 and 2, with fewer falling in Grades 3 and 4. There were no deviations that led to the death of the subject (Grade 5). DISCUSSION: This method of classification would help trial managers decide on the action to be taken on the occurrence of deviations, which would be based on their impact.
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.