Narrative Writing

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Narrative writing is a form of storytelling that conveys a sequence of events or experiences in a coherent and engaging manner. It involves using descriptive language, vivid details, and a narrative structure to captivate readers and create an immersive experience. Narrative writing can take various forms, such as short stories, novels, memoirs, or personal essays. It allows writers to explore characters, settings, conflicts, and themes, and to evoke emotions and create connections with readers. Here are some key elements and techniques commonly used in narrative writing: Characters: Develop well-rounded and relatable characters that readers can connect with. Describe their physical appearance, personality traits, motivations, and conflicts. Show their growth and transformation throughout the story. Setting: Create a vivid and immersive setting that transports readers to a specific time and place. Describe the sights, sounds, smells, and atmosphere to help readers visualize the surroundings and feel a sense of presence. Plot: Construct a compelling plot that follows a narrative arc, including an introduction, rising action, climax, falling action, and resolution. Build suspense, tension, or excitement by introducing conflicts, challenges, or obstacles for the characters to overcome. Dialogue: Use dialogue to bring characters to life and reveal their thoughts, emotions, and interactions. Use dialogue tags and gestures to indicate who is speaking and to provide context or description. Point of View: Choose a narrative point of view, such as first-person (I, me) or third-person (he, she, they), to determine the perspective from which the story is told. Consider the impact of the chosen point of view on reader engagement and character development. Descriptive Language: Utilize descriptive language and sensory details to paint a vivid picture in readers' minds. Engage the senses by describing sights, sounds, smells, tastes, and textures. Show, rather than tell, by using specific and evocative words and phrases. Narrative Voice: Develop a distinctive narrative voice that reflects the personality, beliefs, or attitudes of the narrator or protagonist. Use the narrative voice to convey emotions, opinions, or reflections, adding depth and authenticity to the story. Symbolism and Imagery: Incorporate symbolism and imagery to enhance the narrative and convey deeper meanings or themes. Use symbols, metaphors, or vivid visual descriptions to evoke emotions, create connections, or emphasize key ideas. Pacing and Structure: Manage the pacing of the narrative by balancing action, dialogue, and introspection. Use paragraphs, chapters, or sections to structure the story effectively, creating natural breaks or transitions.

Health & Medicine

Welcome
NARRATIVE WRITING IN PHARMACOVIGILANCE-
EFFECTIVE WAYS AND BEST PRACTICES
Dr Noor E Ayeen Khatoon
MBBS
CSRPL_INT_OFL_WKD_160/0922
11/3/2022
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Index
⮚ Definition and overview
⮚ Aim and purpose
⮚ Application
⮚ Guidelines
⮚ Flow
⮚ Contents
⮚ Tips
⮚ Effective ways
⮚ Samples
⮚ References.
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DEFINITION AND AIM
⮚It is a medical report containing all known clinical and related information including patient
characteristics, reporters information, type of report, therapy details, medical history, the
clinical course of the events, diagnosis, adverse reactions including the outcome, relevant
laboratory evidence, and any other information that supports or refutes an adverse reaction.
⮚It is a part of ICSR.
purpose
⮚The causal relationship between the drug and the event.
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WHERE DO WE USE NARRATIVES?
COMPLETED STUDIES
CASE REPORTS ONGOING CLINICAL TRIALS
PROGRESS AND SAFETY REPORTS
POST MARKETING SURVEILLANCE
ICSR FORMS
HOSPITAL RECORDS
DISCHARGE Summaries
application

FLOW OF A NARRATIVE
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REPORT TYPE AND REPORTER INFORMATION
PATIENT DEMOGRAPHICS
PATIENT MEDICAL HISTORY AND CONCOMITANT MEDICATION
INFORMATION
SUSPECT PRODUCT INFORMATION
CLINICAL COURSE OF THE EVENTS,TEMPORAL RELATIONSHIP WITH
THE DRUG
NATURE ,INTENSITY , SEVERITY ,SERIOUSNESS OF THE EVENT
TREATMENT ADMINISTERED IF ANY
ACTION TAKEN
OUTCOME OF THE EVENT
LAB INVESTIGATIONS AND POSTMORTEM REPORT (IF
APPLICABLE)
CLINICAL RELATIONSHIP WITH THE DRUG…CAUSALITY
ASSESSMENT
MEDICAL EXPERT COMMENT

US FDA AND EMA GUDELINES
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NEVER REVEAL THE
PATIENTS OR
SUBJECTS IDENTITY
CONSISTENT WITH
DATA IN SOURCE
DOCUMENT
STAND ALONE
MEDICAL
REPORT
SERIOUS (EXPECTED AND UNEXPECTED)
NON SERIOUS ( UNEXPECTED )
AVOID
ACRONYMS
AND
ABBEVIATIONS
IN CHRONOLOGICAL
ORDER OF PATIENTS
EXPERIENCE OF
EVENT.

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CONTENTS OF A NARRATIVE WRITING IN POST-MARKETING SURVEILLANCE.
NARRATIVE WRITING CONSISTS OF AT LEAST 4 PARAGRAPHS.
It should compile all the provided data for the reviewers to conclude with the causality and seriousness assessment.
After the introductory information of the reporter and the patient/subject.
FIRST PARA
• INDICATION
• HISTORIC
CONDITIONS.
SECOND PARA
• THE EVENT
THIRD PARA
• MEDICATIONS
WITHIN 2
WEEKS OF
EVENT ONSET
FOURTH PARA
• CAUSALITY
ASSESSMENT

differences
The narrative writing for clinical trial cases-
• Protocol /Study ID: XXX
• Study Title /Study Description :
• Screening number/ Randomisation no: XXX
• Patient ID / Subject ID: XXX
FOLLOW-UP CASES
• Prepare a new narrative
• Add the additional information in a separate paragraph
• Highlight the newly added data.
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Literature reports
• Author comment
• Literature citation.

TIPS FOR WRITING A GOOD NARRATIVE
⮚The reporter’s verbatim should be used. Grammar and spelling should be accurate.
⮚Maintain chronology of events as occurred not as reported. The date and time should be
as accurate as possible.
⮚ Follow-up cases should highlight the newly added data.
⮚Should be written in 3rd person’s past tense.
⮚Avoid abbreviations and acronyms.
⮚Never give judgemental comments. Mention in passive voice and only mention facts.
⮚Narrative should serve as a comprehensive stand-alone medical report containing all
known relevant clinical and non-clinical data.
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Effective ways FOR WRITING An ideal NARRATIVE
Review of data
Quality validation
Quality calibration.
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.
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Thank You!
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(India | Canada)
9121151622/623/624
info@clinosol.com
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Clinical trials are complex endeavors that involve numerous stakeholders, vast datasets, and intricate processes. To streamline operations, enhance collaboration, and improve efficiency, the integration of clinical trial systems has emerged as a pivotal solution. This strategic approach involves connecting various components, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and electronic health records (EHR), fostering a cohesive ecosystem that accelerates the pace of research and ensures data accuracy.

Integration of Clinical Trial Systems: Enhancing Collaboration and Efficiency

ClinosolIndia

Pharmacovigilance, a critical component of the healthcare and pharmaceutical industry, plays a pivotal role in monitoring and ensuring the safety of drugs. As personalized treatment approaches gain prominence, the responsibilities of PV companies become even more significant. This article explores the key functions of pharmacovigilance companies in the context of personalized medicine, focusing on their role in ensuring drug safety and mitigating potential risks associated with tailored therapeutic interventions.

Pharmacovigilance (PV) Companies: Ensuring Drug Safety in Personalized Treatm...

ClinosolIndia

Clinical trials play a pivotal role in advancing medical research and ensuring the efficacy of new treatments. In the context of precision medicine, where therapies are tailored to individual characteristics, adaptive design emerges as a powerful strategy to optimize clinical trial outcomes. This approach deviates from traditional fixed trial designs, allowing for modifications based on accumulating data, thus enhancing efficiency, flexibility, and the likelihood of success in precision medicine endeavors.

Adoptive Design: Optimizing Clinical Trial Strategies for Precision Medicine

ClinosolIndia

Artificial Intelligence In Clinical Trial

ClinosolIndia

Precision medicine, with its focus on tailoring healthcare interventions to individual characteristics, is undergoing a transformative evolution propelled by emerging technologies. From advanced genomic tools to artificial intelligence, these technologies are revolutionizing our ability to understand, diagnose, and treat diseases at an unprecedented level of specificity. This article explores the key emerging technologies shaping the future of precision medicine.

Emerging Technologies Shaping the Future of Precision Medicine

ClinosolIndia

Precision medicine, with its focus on tailoring medical interventions to individual characteristics, benefits significantly from the integration of machine learning (ML) algorithms for predictive analytics. These algorithms analyze complex datasets, identify patterns, and generate predictions that inform personalized treatment strategies. This article explores the diverse applications of ML in precision medicine, highlighting the key algorithms driving predictive analytics in this transformative field.

Innovations in Liquid Biopsies for Precision Cancer Diagnosis

ClinosolIndia

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