A retrospective study: root cause analysis of reported serious adverse event and development of corrective action and preventive action for deviated serious adverse event reports at a clinical trial site management office

Authors

  • Dayanand Raddi Department of Clinical Research, KLE-College of Pharmacy, Belagavi, Karnataka
  • Revena S. Deveriniti Department of Clinical Research, KLE-College of Pharmacy, Belagavi, Karnataka http://orcid.org/0000-0001-9785-6814
  • M. S. Ganachari Department of Clinical Research, KLE-College of Pharmacy, Belagavi, Karnataka
  • Geetanjali Salimath Department of Clinical Research, KLE-College of Pharmacy, Belagavi, Karnataka

DOI:

https://doi.org/10.18203/2349-3259.ijct20203106

Keywords:

Serious adverse reaction, Investigational product, Ethics committee, Safety reporting, Principal investigator, Corrective action and preventive action

Abstract

Background: Serious adverse events (SAEs) are preventable if reported on time. Assessment of harm caused by clinical trials is difficult than assessing the benefits as it relied on the information as recorded by the study team. Hence it is important to have knowledge about quality safety reporting. The objectives of the study were to assess root cause for the timeline deviation found in SAE report and to develop the corrective action and preventive action to minimize deviation rate.

Methods: A retrospective study was conducted in KLE’s Hospital and MRC, Belagavi. Data was collected from SAE documented trial study files. Between August 2016 to August 2019, 25 SAE occurred during clinical trials which were included in the study through complete enumeration and purposive sampling.

Results: Data was analyzed for SAE reporting timeline where in no deviation was found in initial report. It was seen that all SAEs were not related to investigational product. The narrations of SAE were according to standardized format as per Ethics Committee review report. A gap was observed between onset of SAE and initial report in 16 case reports.

Conclusions: The study concluded that there was a lag in reporting from onset of SAE to initial report even though there was no deviation observed in the initial report timeline. The main contributing factors were admitting in different hospital without information and lack of knowledge by subjects or their relatives which shows the need of awareness about quality safety reporting.

References

Introduction of Clinical Trials. Available at: https:// www.webmd.com/a-to-z-guides/clincial-trial-guide-patients#1. Accessed on 10 September 2019.

Sil A, Das NK. Ethics of safety reporting of a clinical trial. Indian J Dermatol. 2017;62(4):387.

SAE reporting timeline guidelines and responsibilities of stakeholders. Available at: https://www.bing.com/images/search?q=sae+reporting+timelines+dcgi&FORM=HDRSC2. Accessed on 10 September 2019.

SAE reporting timeline and compensation. Available at: https://www.slideshare.net/ShwetaL3 /sae-reporting-timeline-and-compensation-2019. Accessed on 19 March 2020.

Introduction & applications of Root cause analysis (RCA). Available at: https://quality-one.com/rca/. Accessed on 11 September 2019.

Introduction & methods of implementation of CAPA. Available at: https://quality-one.com/capa/. Accessed on 11 September 2019.

Crépin S, Villeneuve C, Merle L. Quality of serious adverse events reporting to academic sponsors of clinical trials: far from optimal. Pharmacoepidemiol Drug Safety. 2016;25(6):719-24.

Hughes S, Cohen D, Jaggi R. Differences in reporting serious adverse events in industry sponsored clinical trial registries and journal articles on antidepressant and antipsychotic drugs: a cross-sectional study. BMJ Open. 2014;4(7):e005535.

Hartung DM, Zarin DA, Guise JM, McDonagh M, Paynter R, Helfand M. Reporting Discrepancies between the ClinicalTrials.gov Results Database and Peer-Reviewed Publications. Ann Int Med. 2014;160(7):477.

Olivier P, Gimbert A, Colin AL, Salvo F, Becker M, Marty V, Petitpain N. Serious adverse drug events related to non-investigational drugs in academic clinical trials: another source of safety data for risk assessment? Br J Clin Pharmacol. 2016;82(4):1069-75.

McDonald CJ, Kalisch Ellet LM, Barratt JD, Caughey GE. An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran. Pharmacoepidemiol Drug Safety. 2014;24(4):399-405.

Lee A, Mills PD, Neily J, Hemphill RR. Root Cause Analysis of Serious Adverse Events Among Older Patients in the Veterans Health Administration. The Joint Commission J Quality Patient Safety. 2014;40(6):253-62.

Chen C, Jia W, Guo D, Zhu M, Xu Y, Wang X, et al. Development of a computer-assisted adverse drug events alarm and assessment system for hospital inpatients in China. Thera Innov Regul Sci. 2020;54(1):32-41.

Tripathi RK, Marathe PA, Kapse SV, Shetty YC, Kamat SK, Thatte UM. Serious adverse events reports: Analysis and outcome of review by an institutional ethics committee of a tertiary care hospital in Mumbai, India. J Empirical Res Human Res Ethics. 2016;11(3):267-73.

Bruland P, McGilchrist M, Zapletal E, Acosta D, Proeve J, Askin S, et al. Common data elements for secondary use of electronic health record data for clinical trial execution and serious adverse event reporting. BMC Med Res Methodol. 2016;16(1):159.

Moore TJ, Furberg CD, Mattison DR, Cohen MR. Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014. Pharmacoepidemiol Drug Safety. 2016;25(6):713-8.

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Published

2020-07-21

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Original Research Articles