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SAFETY NARRATIVES WRITING

Patient narrative is one of the key elements while reporting about the clinical trial. It aids in analyzing the safety profile of a drug. The document includes summaries about specific events that are clinically relevant, experienced during or immediately after completion of a clinical trial. The safety narratives include events experienced by the healthy individuals and the patients enrolled in the clinical trials. These are the documents prepared every time a particular drug or investigational product undergoes clinical trial i.e., all phases of clinical trials.

ICH GUIDELINES FOR SAFETY NARRATIVES

The International Conference on Harmonization (ICH) tripartite guideline on the Structure and Content of Clinical Study Reports (CSRs) E3 (Section 12.3.2) provides brief information about the content of the safety narratives. All those adverse events that may affect the safety categorization of the drug must be included in the safety narratives. The events that are not related to the drug under investigation or due to comparator drug may either be described briefly or can be provided as listings to the Regulatory agencies.

WRITING PATIENT SAFETY NARRATIVES

Safety Narratives are an important part of clinical study reports that are to be submitted to the healthcare regulatory agencies for the approval of the drug. The inclusion of the patient narratives is to allow the safety analysis of the drug by the regulator officials.To harmonize the content of the safety narratives, the ICH guides the incorporation of information in the document. The safety narrative consists of various information such as the nature, intensity, and outcome of the event, treatment or intervention, action taken with the study drug (and timing) about the event, the clinical course leading to the event and Investigator’s and Sponsor’s (if appropriate) opinion on causality.

The development of safety narratives requires the extraction of information from several databases. These are listings from the clinical research database, patient profiles, case report forms (CRFs), CIOMS or MedWatch forms or SAE forms, adjudication forms or adverse events of special interest summaries and Data Clarification Forms (DCFs).

WHY ACCURACY AND CONSISTENCY REQUIRED IN THE PATIENT SAFETY NARRATIVES?

Accuracy and consistency are important prerequisites for developing safety narratives. The safety narratives must clearly and unambiguously disseminate the information. Unclear information increases the risk of rejection of clinical trial reports by the regulatory agencies. Many pharmaceutical organizations and clinical research organizations do not have the expertise to prepare safety narratives. In such cases, the services of agencies involved in creating patient safety narratives are required.

WHY CHOOSE SMIQGEN?

SMIQGEN is one of the best agencies in developing patient safety narratives. Our medical writers have several years of experience in developing, drafting, and reviewing regulatory documents, including patient narratives. The medical writers at SMIQGEN have advanced educational qualifications, such as PhD and Pharm D. SMIQGEN remain in touch with various departments such as clinical data management, regulatory, pharmaco-vigilance, biostatistics, and project management. The team at SMIQGEN may also interact with the clinical research organization if required.

SMIQGEN provides highly consistent, accurate, and comprehensively written patient safety narratives that reduce the risk of clinical trial report rejection. SMIQGEN is capable of handling all your requirements related to patient narratives. If you have trouble in gathering the relevant information or facing challenges in drafting the document related to patient narratives, contact SMIQGEN.

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