After a two-year collaboration, two industry nonprofits have unveiled an approach for safety reporting that will help sites reduce the amount of duplicate adverse event (AE) data entry they currently do to meet sponsor and regulatory requirements.

With the help of industry consortium TransCelerate, the Clinical Data Interchange Standards Consortium (CDISC) has identified 156 key factors that should be included in AE safety reports and mapped out how data fields could be added to electronic case report forms (eCRF) to capture all necessary information once and automatically produce standardized reports.

The standards CDISC released last week in a 50-page report follow the principles detailed in the International Council on Harmonization’s (ICH) E2B guideline on clinical safety data management and individual case safety reports (ICSR).

“The aim of this is to make the process of submitting ICSRs to regulators easier because there’s a structure now,” CDISC Project Manager John Owen told CenterWatch Weekly.

The new standards are an update to CDISC’s existing standards, first released in 2013, and for the first time include a format for reporting specifically on serious adverse events (SAE).

“Now this additional data can be entered once and transferred to a sponsor organization’s safety database so they have the information they need,” Owen said. “It’s really expanding the ability to reduce duplicate data entry.”

CDISC said that it highly recommends sites record only one diagnosis, sign or symptom per line of the eCRF, indicate whether the cause of an AE is related to the study treatment and cannot be reasonably explained by other factors, and record changes made to the study treatment in response to an AE. CDISC also strongly recommended that after sponsors receive the data from sites, they conduct a causality assessment and try to figure out whether the AE or SAE could have been related to their product, treatment or intervention.

Most of the SAE standards, 71 in total, address the characteristics of trial participants and cover a variety of topics, including demographics, medical history, relevant procedures, vital signs, past drug history and death details. CDISC recommended that a site’s clinical investigator assign a unique identifier to each trial participant and provide such information as relevant medical conditions or events as defined in the protocol, names of any relevant medical procedures, concomitant medications and current conditions, the reported primary cause of a participant’s death, if necessary, and whether an autopsy was performed.

Data from laboratory tests and procedures performed to diagnose or confirm an AE or SAE event should be included in an eCRF, CDISC said, with both positive and negative results reported.

The narrative portion of an SAE report — where all relevant clinical and related information is summarized into a comprehensive, standalone “medical story” to either support or disprove a diagnosis for an adverse drug reaction — should include patient characteristics, therapy details, prior medical history, the patient’s clinical course of events and any laboratory evidence. The information should be presented in a logical time sequence, ideally in chronological order of the patient’s experience, rather than in chronological order of when the information was received, according to CDISC.

CDISC based its recommended narrative structure on ICH E3 — Structure and Content of Clinical Study Reports guideline — and said the narrative should be able to answer four key questions:

• Is a diagnosis possible?
• Have the relevant diagnostic procedures been performed?
• Were alternative causes of the event/reaction(s) considered?
• What additional information may be needed to allow for the final conclusion regarding whether the SAE was caused by the product?

To request a copy of CDISC’s report, click here: https://bit.ly/2QTcLAs.