Observational studyPloS one2016
An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.
Observational study in PloS one, 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
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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.
- Evaluation of the first standardized registry of approved research studies by the research ethics committees in Ecuador.BMC medical ethics · 2025Observational
- Incidence and Characterization of Important Protocol Deviations in Clinical Trials in Argentina.Therapeutic innovation & regulatory science · 2025Observational
- Article
- A study on the normative path of ethics review in China: based on the perspective of Panopticism.Frontiers in medicine · 2023Article
- The Successful Synchronized Orchestration of an Investigator-Initiated Multicenter Trial Using a Clinical Trial Management System and Team Approach: Design and Utility Study.JMIR formative research · 2021Article
- STROCSS 2021 guidelines: What is new?International journal of surgery case reports · 2021Article
- STROCSS 2021 guidelines: What is new?Annals of medicine and surgery (2012) · 2021Article
- Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: A review.Contemporary clinical trials communications · 2018Review
- An audit of institutional ethics committee queries raised after initial project submission by a single research department at a tertiary referral center in India.Perspectives in clinical researchArticle
- Monitoring of approved studies: A difficult tightrope walk by Ethics Committees.Perspectives in clinical researchArticle
- Unreported protocol deviations - The tip of the research-berg.Perspectives in clinical researchArticle
- Ethics Committees in India: Past, present and future.Perspectives in clinical researchReview
- 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
- A crucial role of on-site clinical trial monitoring: Insights from the ethics committee.Perspectives in clinical researchArticle
- Post-approval process: A challenge for ethics committees.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
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI) for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD) and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47). Maximum study procedure related PDs were due to patient visiting outside window period (126/304). Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447). The most common corrective actions stated by PI were participant counseling (85/323) and caution in future (70/323). The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.
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