One of the reasons that a research molecule undergoes through different phases of clinical trials is to establish the safety and efficacy of the drug.
To establish the safety profile of any drug, the most important aspect is to evaluate every adverse event AE that a clinical trial individual experiences. This detail is provided by any investigator or sponsor through the narratives that is prepared post the analysis of a serious AE. The purpose of this article is to emphasize the importance of these narratives. With the entire focus of Indian regulations on the safety of human clinical trials participants, serious adverse event SAE reporting has become an important obligation, especially for the sites.
Medical management and compensation quantum decisions are dependent on the information provided through the SAE forms in the Schedule Y Appendix XI format. An event is considered life threatening if it is suspected that the individual was at substantial risk of dying at the time of the AE. Requires inpatient hospitalization or prolongation of existing hospitalization —.
Includes an AE which resulted in a substantial disruption of a person's ability to conduct normal life functions, i. Every stakeholder — health-care professionals, patients, regulators, Ethics Committees, policy makers, and health ministry must have access to high quality, up-to-date information, tailored to their abilities and preferences, about medicines and their use, and about health care in general, and about ways to promote health and prevent any adverse effect.
Aspects that any safety communication aims to:[ 2 ]. Provide timely, evidence-based information on the safe and effective use of medicines and appropriate clinical management of patient treatment.
Facilitate changes to health-care practices including self-medication practices where necessary. Marketing authorization holders are responsible for collecting, reviewing, and analyzing spontaneous case reports of suspected adverse reactions to medicines by patients and health-care professionals, in scientific literature and elsewhere during postmarketing surveillance of medicines. Hence, narratives become an integral part of every SAE description that is experienced by a trial individual.
As per International Conference on Harmonisation ICH , SAE narrative is a detailed, stand-alone document, which presents a full and clinically relevant, sequential account of the progression of an event or events. SAE narrative writing requires a combination of medical and technical writing skills. Section As per ICH E3 guidelines,[ 5 ] a patient safety narrative should describe the following:.
Food and Drug Administration FDA describes narrative as a small document — words that is required by the FDA to briefly describe the events in the life of an individual. Narratives are written from two sources:[ 7 ].
From safety reports maintained by the safety officer, who is a physician working on-site. For writing the SAE narrative, a step-wise approach is helpful. The steps are as follows:. Mention the birth year, gender, and race of the clinical trial individual experiencing the event in compliance with local regulatory requirements.
Record the individual's height in cm and weight in kg at the onset of the experienced event. Document the indication for which the study medication is being administered. Include the details of the protocol and mention about the blind if any. The phase of the trial to which the individual belongs may also be included to provide clarity on the stage when the event was experienced.
Patient history medical history, concomitant diseases, family history, and concomitant drugs. Mention every detail about concomitant conditions and their onset dates. Also include relevant past conditions. It includes following events:. A clinical trial always carries the risk of undesired outcomes that can even be life-threatening in some cases.
Thus, the awareness about the classification of events into Adverse Events and Serious Adverse Events can be extremely helpful in minimizing damage and saving lives of the participants. Your email address will not be published. Published by Doctor Erick at October 27, Adverse Event AE : Adverse Events refers to any situation where the candidates participating in a clinical trial shows some adverse medical symptoms.
These symptoms may be revealed in the laboratory test reports or physically examination of the participants. Unrelated Event Any adverse experience, event, incident, interaction or outcome for which a causal relationship with the study article, study intervention or study participation is not suspected. This includes the electronic submission and the AE reporting form.
In addition, the appropriate Dean and Office of Risk Management should be notified within hours. The IRB-HSR will make a Late Reporting notation to all internal, serious, unexpected adverse events reported greater than 7 days from the time the study team received knowledge of the event.
Repeated incidences of late AE reporting may constitute continuing noncompliance. The IRB may not be the only entity to which your adverse event must be reported. If the sponsor requires the study team to submit external AEs, the study team may stop sending these reports:.
There are times when SAEs Reports will need to be corrected or deleted after they have been submitted. There are different actions that can be taken at various stages of SAE submission. Please find the scenario that best describes the status of the AE in question and follow the directions for that scenario. You discover that you need to make a correction or delete the SAE.
You will receive an email explaining that the SAE has been returned and a list of discrepancies will be presented for resolution.
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