The Clinical Study Report (CSR) represents the ultimate synthesis of years of clinical development. It is the primary document reviewed by regulatory agencies such as the NMPA, FDA, and EMA to assess the safety and efficacy of a new drug or medical device.
A clinical study report audit is an independent, systematic evaluation of the CSR. Its objective is to ensure that the narrative accurately reflects the underlying source data and that all conclusions are supported by the provided statistical evidence. By acting as a critical "third eye," Protheragen helps sponsors identify discrepancies between the CSR text and the Tables, Listings, and Figures (TLFs) before they become major findings during a regulatory inspection. This proactive approach reinforces the scientific credibility of the submission and facilitates a smoother review process.
Our auditing methodology is grounded in regulatory requirements and focuses on the high-risk areas of the report where errors most frequently occur.
We perform a meticulous word-for-word and number-for-number check between the CSR text and the source TLFs. We verify that every efficacy result, safety summary, and demographic detail in the narrative is accurately derived from the underlying datasets.
We audit the CSR against the mandatory structure defined by ICH. This includes ensuring the presence of all required sections, from the Synopsis and Ethics through to the detailed Safety Evaluation and Efficacy Evaluation.
Focusing on the "Most Frequent Adverse Events" and "Deaths and Other Serious Adverse Events" sections. We ensure that the listing of serious adverse events (SAEs) in the CSR perfectly matches the safety database and the Trial Master File (TMF).
We verify that the primary efficacy analysis reported in the CSR is consistent with the pre-specified Statistical Analysis Plan (SAP). Any post-hoc analyses are audited to ensure they are clearly identified and justified to prevent data-dredging concerns.
A CSR is only as strong as its appendices. We audit the organization and completeness of the appendices, ensuring that Case Report Forms (CRFs), Individual Subject Data Listings, and investigator information are correctly cross-referenced.
While the focus is on data, we also audit the clarity and objectivity of the writing. We ensure that the narrative is transparent, does not obscure unfavorable data, and maintains a consistent tone throughout the document.
The CSR serves as a key document supporting clinical trial evaluation. Structured CSR audits help organizations assess the quality, consistency, and traceability of clinical reporting. Effective CSR audit programs may help organizations:
Evaluate consistency between clinical data and reported conclusions
Support data traceability and reporting transparency
Identify documentation inconsistencies and quality gaps
Improve coordination between functional departments
Assess alignment with reporting guidelines and regulatory expectations
Enhance inspection and submission readiness
If you need a third-party audit for a clinical study report, please feel free to contact us. We examine the entire CSR against source data and ICH, delivering a detailed findings report that supports your regulatory submission.
1. Can your audit support global submissions targeting both the NMPA and the FDA?
Absolutely. While our audits are rooted in the universal ICH guidelines, we can also evaluate the CSR for compliance with specific regional regulatory expectations or formatting requirements requested by the NMPA, FDA, or EMA.
2. What source documents are checked during a CSR audit?
The audit cross-references the CSR against the final protocol, all amendments, the statistical analysis plan (SAP), the complete set of tables, listings and figures (TLFs), the clinical database, the Trial Master File (TMF) index, and key safety documents such as SAE narratives.
3. What is the difference between a CSR audit and a peer review of the medical writing?
A peer review typically evaluates the clarity, grammar, and medical sense of the report. A CSR audit is a structured, independent quality check focused on factual accuracy, data concordance, regulatory compliance with ICH, and the traceability of every statement back to source documents.
4. How does the audit ensure confidentiality of the study data and the CSR itself?
All audit activities are conducted under a confidentiality agreement. Data and documents are reviewed within a secure environment, auditor access is strictly controlled and logged, and all materials are securely removed or destroyed upon completion of the audit, with no copies retained.