Faster Safety Reporting: Qualitative Analysis Guide

According to the PLOS One study published July 30, 2026, trial staff describe safety reporting as a ‘‘tightrope’’ between over-reporting and under-reporting, driven by uncertainty, red tape, inconsistent requirements, lack of clarity, and gaps in experience. The PLOS One study is the source for the participant quotes and statistics below. Evidano is an AI-powered qualitative data analysis platform that helps researchers analyze interviews, open-ended surveys, and documents.

• 23 CTU staff participated in four focus groups run between 01-July-2024 and 04-March-2025, according to PLOS One published July 30, 2026.
• Participants came from 10 of 52 UK-registered trials units and had a mean of 13.3 years’ trial experience (SD 9.5), as reported in PLOS One on July 30, 2026.
• The PLOS One authors note that legislative changes signed in 2025 and coming into force 28 April 2026 aim to reduce duplicative reporting and codify risk levels for trials.
• Practical solutions reported in PLOS One include clearer regulator guidance, role-specific training, and CTU-level knowledge sharing platforms.

The PLOS One study asked: what are the barriers and solutions to efficient safety reporting for academic trial staff. The answer is a qualitative focus group study with 23 participants in four online focus groups held between 01-July-2024 and 04-March-2025, as described in PLOS One published July 30, 2026.

The PLOS One study recorded and auto-transcribed Microsoft Teams sessions, then cleaned and pseudonymised transcripts before applying Reflexive Thematic Analysis, using NVivo for coding. The analytic output produced one overarching theme, "Walking on a tightrope: Making justifiable decisions, " and five subthemes that explain sources of inefficiency.

Direct quotes from participants illustrate the tensions identified in PLOS One, for example: "Generally, you’ve got to balance what you need to collect in terms of safety reporting and in terms of what’s needed to monitor the safety of the drug" (Participant 16, FG3), and "...It feels difficult and there is always that element of anxiety that you’ve got it wrong" (Participant 20, FG4).

CTU teams must shift from documenting every event to documenting justified, risk-proportionate information as required by the April 28, 2026 regulations, according to PLOS One and MHRA guidance.

• Action: map who in your team makes causality and reporting decisions, and document decision rules to increase transparency and defendability, as recommended by PLOS One.
• Action: standardise SOP language across similar trials to avoid site burden and double data entry that participants described in PLOS One.
• Action: implement role-specific, bite-sized training and example-based templates because PLOS One participants recommended practical, illustrative training to build confidence.

The PLOS One study published July 30, 2026, shows that CTU staff experience safety reporting as a balancing act driven by uncertainty, bureaucracy, inconsistent expectations, and training gaps.

Applied qualitative analysis, enhanced with AI transcription and thematic tools, can make reporting decisions more transparent, less duplicative, and faster to justify to regulators and sponsors.

If your team wants to pilot a rapid qualitative audit of recent SAE decisions and generate shareable templates and evidence trails, try an AI-enabled workflow that handles transcription, coding, and searchable decision logs.

To get started with a free trial, Try Evidano for free.