ICSR Narrative Writing_Katalyst HLS

12-26-2016Katalyst Healthcares & Life Sciences

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ICSR Narrative Writing

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Patient narratives are written for deaths, serious adverse events (SAEs), or adverse events (AEs) of special clinical interest (eg, AEs associated with the mechanism of action being studied, laboratory results of special interest, regulatory requirements etc.) and those leading to permanent discontinuation from a clinical trial. Patient narratives form an important component of clinical study reports (CSRs) and pharmacovigilance activities (e.g. post marketing safety reports).

Also referred as patient safety narratives. A patient safety narrative provides a full and clinically relevant,

chronological account of the progression of an event experienced during or immediately following a clinical study.


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As per International Conference on Harmonisation (ICH) E3 (Section 12.3.2), a patient narrative should describe :

The nature, intensity and outcome of the event Clinical course leading to the event Timing of study drug administration Relevant laboratory measures Counter measures Action taken with the study drug in relation to the event Post mortem findings (if applicable) Investigator’s and sponsor’s opinion on causality Additionally, patient identifier, age, gender, clinical condition, disease being treated,

relevant medical history, concomitant and prior medications should be included.All this information is extracted from the source files (e.g. Council for International Organisations of Medical Sciences [CIOMS] form, Case Report Form [CRF], MedWatch form, Data Clarification Form [DCF], summary tables, and listings). Sometimes, the CIOMS form can be directly attached as an appendix to the CSR.


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Some aspects that you should clarify include: Sentence structures (e.g. some clients prefer to

start a sentence with a date) Date formats Which medical history and concomitant

medications are considered relevant Inclusion or exclusion of normal ranges for

laboratory results Trade or generic names for drugs


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The information provided in the narrative should be consistent with the data appropriately reflected in all the other relevant ICH-E2B(R2) data elements of the ICSR.

During the interim arrangements, the case narratives included in the ICSRs submitted to the competent authorities in Member States by marketing authorisation holders, should not be modified or deleted when the ICSRs are forwarded to the EudraVigilance database by the competent authorities.

New information should be clearly identifiable in the case narrative (data element ICH-E2B(R2) B.5.1) and provided in a structured format in the applicable ICH-E2B(R2) data elements.


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CT narrative Template: Protocol/Study ID: XXXX Study Title/Study description: Post-Marketing Surveillance of DRUG mg (ingredient) to Evaluate Its Safety

and Efficacy. Screening number/Randomization No: XXX-XX-XXX Patient ID/Subject ID: XXXX-XXXX This case was reported by an investigator on DD-MMM-YYYY. This case refers to a XX-year-old female/male patient who had liver function test (LFT) elevation during Drug

therapy. The patient's relevant medical history included: The patient's concomitant medications included The patient's laboratory data on (Pre therapy) The patient was administered with About AE/SAE The patient's laboratory data on (Post therapy) Action taken with respect to Drug was no change and the patient was recovered from the event LFT

elevation on DD-MMM-YYYY. The reporter assessed the causality between the medication and the event LFT elevation as possibly

related.12-26-2016Katalyst Healthcares & Life Sciences

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Spontaneous Narrative Template:This initial spontaneous case was reported by a physician via sales representative via Partner, on XX-XXX-XXXX. This case refers to a XX-year-old male/female patient who experienced increased alkaline phosphatase levels following therapy with Drug (ingredient). The patient's medical history was not reported. Current condition included Crohn's disease. The patient's concomitant medications were not reported. The patient commenced therapy with Drug (unspecified dose), weekly via intravenous route indicated for Crohn's disease on since an unspecified date in XXX-XXXX. On an unspecified date, since the start of Drug therapy, the patient suffered from increased alkaline phosphatase levels. It was reported that the other liver values were in normal ranges. At the time of this report, action taken with Drug was ongoing and the outcome of the event was unknown. The reporter assessed the case to be non-serious and the causality between the medication and the event was not reported.

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This initial [serious/non-serious] [spontaneous/literature] report, which originated from [country] was received by [Marketing Partner’s Name] on [date DD MMM YYYY]. Information has been received from a [reporter] concerning a [age] year old [male/female] with a medical history of [history, including the duration of concurrent illness, age at diagnosis, date of diagnosis or onset date not reported]. The patient commenced treatment with [SUSPECT PRODUCT], dose, frequency, on date for indication. Concomitant therapy included [generic name of relevant concomitant drugs with/without indication if appropriate. Or provide a general statement such as subject was also receiving multiple concomitant medications, with or without indications (for example, he/she was taking multiple medications for pain, hypertension and depression). Note that concomitant medications include those medications taken within a reasonable time frame (30 days) prior to the onset of an adverse event and medications taken by the subject at the time of the reported adverse event.]

On [date MM DDD YYYY], the subject presented with event [detailed event description including signs, symptoms and details about hospitalisation including prolongation of existing hospitalisation]. which required hospitalisation. The subject’s laboratory results on [DD MMM YYYY] were as follows: [list relevant physical findings, exams and laboratory results]. Corrective treatment for the event included [describe medications, procedures, tests, investigations etc.]. [State outcome of event following treatment (recovered, unresolved, recovered with sequelae (describe sequelae), or death). Note if event resolved spontaneously]. [Fatal patient outcome details: include date and cause of death, the timing of death in relation to the event onset and suspect drug therapy duration].The reporter assessed the events as being serious/non serious [if serious, state reported seriousness criteria] physicians assessment of intensity of event (e.g. mild, moderate, severe) and relatedness of event to products include reported rationale for causality assessment.] The final outcome of the event was [state reported outcome] at the time of this report. No further information was provided. [Company’s medical assessment and comment: Include the facts that the company believe are relevant to the case].

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Follow-up information received on [DD-MMM-YYYY] from [source] (or Source Data Verification received on…., or Data Correction Made on…., etc):

[Briefly describe additions, corrections and/or deletions].


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Literature Narrative Template: This is a report from literature which described Anti-TNF, Infliximab And Adalimumab, Can Be Effective In Eosinophilic Bowel Disease: A Report Of Eight Pediatric Cases.Literature source Turner D, Wolters VM, Russell RK, Shakhnovich V, Muise AM, Ledder O, Ngan B, Friesen C. Anti-TNF, Infliximab And Adalimumab, Can Be Effective In Eosinophilic Bowel Disease: A Report Of Eight Pediatric Cases. J Pediatr Gastroenterol Nutr. 2012 Dec 5;6(6):659-65..Abstract: Eosinophilic enterocolitis (EEC) is an emerging distinct inflammatory bowel disease of unknown etiology. There are no published data on the effect of infliximab or adalimumab for the treatment of refractory cases. METHODS: A report of all pediatric EEC cases treated with anti-TNF, identified after an open international call. RESULTS: We describe here the first eight children with refractory EEC who were treated with infliximab (75% males; mean age at diagnosis 8.6 ± 4.03 (range 1.6-14 years), mean age at infliximab treatment 11.7 ± 4.4 (range 4.2-16 years)). Allergic and infectious causes of EEC were excluded in all cases. Rapid and complete clinical remission was documented in 6 (75%) children following the induction infusions; 3 (38%) with endoscopic remission, 2 (25%) with endoscopic improvement and one unknown. Four of the six responders had secondary loss of response and were switched to adalimumab, three of whom with sustained remission using high doses. Overall, the six responders were followed for a median of 7 years (range 4-12; IQR 6.4-8.8 years) without evidence of developing Crohn's disease or ulcerative colitis. The only case with macroscopic findings on endoscopy was a primary non-responder.This file represents a patient no. 1 of 8. Description regarding patient no: 1The reporting physician considered the event serious (Medically significant).Conclusion: Infliximab and adalimumab may be effective in cases of refractory idiopathic EEC.

11Important Points to Remember:

Narrative should be precise and concise. Double check spell mistakes, spaces, format, flow of narrative in agreed chronology Do not repeat the information. Abbreviations should be expanded once. Globally accepted abbreviations ex: ECG need not be expanded. Avoid using short forms in narrative. Always write narrative in third party saying and in past sentences. Do not change the meaning of narrative by adding own supportive words/conclusion. The verbatim should be written as it is presented in source document. Use quotation

marks to present strange verbatim terms. Try to avoid exceeding characters to make successful E2B submission (the narrative

field has a 20,000 character limit and the case comment has 2,000 character limit). Use paragraphs to present narrative in style and logical format.


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ICSR Narrative Writing_Katalyst HLS