Narratives for Clinical Trials

As a data analyst for a three-year project with a Pharmaceutical Company, I analyzed the patient data from the safety reports. It included transcribing information from patient case safety reports into a safety database in the form of a drug safety/ scientific narrative.

The purpose of documenting the narrative is to summarize all clinical information, including but not limited to patient demographics, characteristics, medical and medication history, the clinical course of events, laboratory evidence, and causality of events in a logical time sequence.

Every narrative is patient-specific.

The goal was to develop a narrative that seamlessly describes all events occurring throughout patients' participation in the clinical trial to contribute to the clinical trial safety reports for reporting to the health authorities. I have written more than 1000 narratives over a period of 3 years while working in drug safety operations.

NOTE: Please refer to the sample narrative below.

Disclaimer: All the information presented in the writing sample below is fictional and will be referenced as a sample demonstrating content writing skills.

The subject id XXXXXXX is a 25-year-old female enrolled in the clinical trial EXXXA2023. The trial EXXXA2023 is a randomized double-blinded study enrolling subjects with severe obesity. This clinical trial is expected to enroll patients for an overall 6- month period. The subject’s randomization id is 2.

The subject’s medical history includes Obesity, Gastrointestinal leak, and bipolar disorder. At the time of the study visit, the concomitant medications already taken by the subject include Aleve, Zanax, and Claritin. The subject started treatment with the double-blinded study medication on 2/23/2022 with a dose of 2mg BID. On 2/23/2022, the subject started experiencing shortness of breath and chest pain. On the same day, the subject was hospitalized at a local hospital. During the hospitalization, the subject was diagnosed with an episode of mild asthmatic attack. The study physician observed the subject during the first 24 hours of the hospitalization. During hospitalization, the subject was advised to undergo counseling for weight management and continued mental health counseling. In addition, the subject also undergoes laboratory testing such as BMI and Lipid profile. On 2/28/2022, the subject wholly recovered from the symptoms of an asthmatic attack. On the same day, the subject was discharged from the hospital. The subject was advised to maintain a healthy weight with proper nutrition and exercise regimen. At the subject’s discharge from the hospital, the study physician assessed no causal relationship between the event asthmatic attack and the double-blinded study medication. However, the study subject was required to schedule follow-up visits two weeks after receiving treatment with the double-blinded study medication.