Narrative writing is a form of writing that tells a story or describes a sequence of events. Narrative writing can take many forms, including novels, short stories, memoirs, personal essays, and even scientific or clinical case reports. The following are some key elements of narrative writing: Plot: The plot is the sequence of events that make up the story. It includes the exposition, rising action, climax, falling action, and resolution. The plot should be well-structured and engaging, with a clear beginning, middle, and end. Characters: The characters are the people, animals, or other beings that are involved in the story. Characters should be well-developed and believable, with their own personalities, motivations, and conflicts. Setting: The setting is the time and place in which the story takes place. The setting should be described in detail, with attention paid to the sights, sounds, smells, and other sensory details that create a sense of atmosphere. Point of view: The point of view is the perspective from which the story is told. It can be first-person (using "I" or "we"), second-person (using "you"), or third-person (using "he," "she," or "they"). The point of view should be consistent throughout the story. Theme: The theme is the central idea or message of the story. It can be implicit or explicit, and may explore universal themes such as love, loss, or redemption.

1. Welcome
Narrative Writing
Dr. Akshaya D
BDS, MPH(Epidemiology and
Biostatistics)
CSRPL_STD_IND_HYD_ONL/CL
S_034/022023
5/5/2023
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2. What is narrative writing?
• It is a style that allows the writer to tell a story.
• It may include actual events told in chronological order or,
• Imagined events told in a timeline created by the author.
• Narrative writing should sustain the reader’s attention and help them visualize a realistic
experience from the words.
• Narrative writing is an important part of Pharmacovigilance(post marketing study reports)
and in clinical study reports(CSR).
• Patient narratives are written when there is an adverse events and serious adverse
events including death.
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3. ICH Guidelines on CSR
• A narrative thus is basically a summary or synopsis of the event that has occurred to a
subject participating in the clinical trial.
• According to the International Conference on Harmonisation (ICH) tripartite guideline
on the Structure and Content of Clinical Study Reports (CSRs) E3 (Section 12.3.2),
a CSR should contain brief narratives describing each death, each other serious adverse
event, and other significant adverse events that are judged to be of special interest
because of clinical importance
• A CIOMS report can be cited as an example of a narrative which provides valuable
information about the occurrence of the event.
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4. Cont.…
• As Per ICH E3 guidelines, a patient safety narrative should describe the following:
• the nature, intensity, and outcome of the event
• the clinical course leading to the event
• an indication of timing relevant to study drug administration
• relevant laboratory measures
• action taken with the study drug (and timing) in relation to the event
• treatment or intervention
• post-mortem findings (if applicable)
• Investigator’s and Sponsor’s (if appropriate) opinion on causality
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5. The narrative should mention,
• patient identifier or subject ID
• age and sex of patient; general clinical condition of patient, if appropriate
• disease being treated (if this is the same for all patients, this information is not
required) with duration (of current episode) of illness
• relevant concomitant/previous illnesses with details of occurrence/duration
• relevant concomitant/previous medication with details of dosage
• test drug administered, including dose, if this varied among patients, and length of
time administered
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6. Data Source
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• A Medical Writer will use various sources of information when preparing patient safety
narratives.
• These include Council for International Organizations of Medical Sciences (CIOMS)
forms, Case Report Forms (CRFs), MedWatch forms, Data Clarification Forms (DCFs),
and clinical database listings.
• Because source data are captured during study conduct and narratives are often prepared
prior to database reconciliation and lock, a Medical Writer is often able to identify data
discrepancies between the clinical study database and other sources.
• The situation is complicated further as CIOMS forms are updated on an ongoing basis
during a clinical study.
• A Medical Writer is well placed to assess the impact of any discrepancies and provide
feedback to a Sponsor, thereby assisting with the data cleaning process.

7. FORMAT & LOCATION
FOR NARRATIVES
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• The guidance is less specific with regard to the format and location of patient safety
narratives, stating [they] can be placed either in the text of the CSR or in Section 14.3.3
(Narratives of Deaths, Other Serious and Certain Other Significant Adverse Events),
depending on their number.
• Although no cut-off is specified, this author suggests that five or fewer narratives may
logically and clearly be reported in text, although this is dependent on several factors,
including therapeutic area, complexity of reporting, relevant course of events, and flow of
information in the CSR.
• If in doubt, it is recommended that narratives should be prepared as separate documents
and compiled in Section 14.3.3 during CSR publishing.

8. PROCESS
• The narrative production process differs across companies and is dependent to a small
degree on whether reporting is performed internally or by a Clinical Research
Organization (CRO).
• INDIVIDUAL CASE SAFETY REPORTS
• patient safety narratives and Individual Case Safety Reports (ICSRs) are not the same.
ICSRs are a core component of pharmacovigilance (PV) services and drug safety.
• A patient safety narrative in, or appended to, a CSR describes all relevant events for a
single patient, with relevant background information
• . An ICSR concerns one patient, one or more identifiable reporter(s), one or more
suspected adverse reaction(s) that are clinically and temporally associated, and one or
more suspected medicinal product(s).
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9. REFERENCES
1. International Conference on Harmonisation. July 1996. Topic E3 Structure and Content
of Clinical Study Reports.
2. EMEA (now EMA; European Medicines Agency). December 2004. Note for Guidance
on the Inclusion of Appendices to Clinical Study Reports in Marketing Authorisation
Applications.
3. Volume 9A of The Rules Governing Medicinal Products in the European Union –
Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2011. Part II
[ONLINE] Available at: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09
2008_en.pdf. [Accessed 29 January 2014].
4. Volume 9A of The Rules Governing Medicinal Products in the European Union –
Guidelines on Pharmacovigilance for Medicinal Products for Human Use. 2011. Annex 1.2.
[ONLINE] Available at: http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-
2008_en.pdf.
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10. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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