Characteristics of a clinical investigation report

The Clinical Investigation Report or Clinical Performance Study Report (CPSR) must be prepared in line with Good Clinical Practice (GCP), ISO 14155 and—for in-vitro diagnostic studies—ISO 20916. The document reflects every study phase: design, conduct, data analysis and final conclusions.

Structure of the Clinical Performance Study Report (CPSR)

A standard CPSR must be consistent with the approved clinical-trial design and include:

  • study objectives and rationale,
  • participant inclusion and exclusion criteria,
  • methods and course of the study,
  • end-points and how they were measured,
  • statistical analysis and data interpretation,
  • discussion of device performance and safety,
  • appendices: CRFs, monitoring records, source data.

End-points and their role in reporting

End-points are the measures used to assess device performance and safety. In IVD performance studies, they may include sensitivity, specificity, predictive values or diagnostic accuracy. The report must describe precisely how the end-points were calculated and analysed and how they influence the device-performance assessment.

Report quality and study credibility

The report must be based on source data, comply with the protocol and follow current guidelines. Editorial quality, data completeness and clear interpretation determine study credibility and the notified body’s decision. Gaps or inconsistencies can lead to additional queries or rejection.

Formal and ethical requirements in reporting

The report must state compliance with the approved protocol, ethics-committee decisions and all significant deviations. Each deviation has to be described and justified—methodologically and ethically.

Inclusion of adverse events (SAE/SUSAR)

An integral part of the report is documentation of Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs). Their occurrence, causal assessment and corrective actions must be presented. This section is critical to safety evaluation.

Reporting studies terminated early

Even if a study is discontinued or end-points are not met, the sponsor must prepare a full report describing the reasons for termination, an analysis of collected data and the impact on product development.

Reporting multi-centre studies

For multi-centre trials the CPSR must provide both aggregated data and centre-level details. Differences in recruitment numbers, timelines or protocol compliance must be explained and considered in the final analysis.

The clinical report must align with earlier documents such as the study plan, investigator brochure, CRFs, statistical analysis and monitoring notes. Notified bodies review the coherence of the entire dossier, not only the report itself.

Lay-person summary requirement

Under Article 77 MDR, the report must be accompanied by a lay summary explaining the study objectives, conduct and results in plain language. It must be provided in the language of the country where the trial was conducted and supports post-market surveillance obligations.

Responsibility and timeline for report preparation

The sponsor is responsible for the report but may delegate authorship to a specialist provider (e.g., CRO or medical writer). The CPSR should be finalised within a few weeks of Last Patient Out (LPO) and, where applicable, submitted to EUDAMED.

How Pure Clinical supports clinical-trial reporting

Pure Clinical provides end-to-end support for clinical-trial reporting:

  • developing report structures compliant with MDR, GCP, ISO 14155 and ISO 20916,
  • performing statistical analysis and drafting the CPSR,
  • preparing MDR-compliant lay summaries,
  • verifying consistency across all related documents,
  • compiling the dossier for EUDAMED submission.

Our experience ensures high-quality, coherent documentation and a shorter pathway to completing the clinical-evaluation process.

FAQ

Can a CPSR be rejected solely due to formal issues, even if the study results are positive?

Yes – notified bodies may reject a report with favorable results if it contains major editorial gaps, inconsistencies with the protocol, or undocumented deviations. Missing methodological justifications, incomplete SAE/SUSAR records, or poorly written lay summaries can be classified as serious formal deficiencies, delaying or blocking approval.

What is the difference between a CPSR and a Clinical Evaluation Report (CER)?

The CPSR documents the results of a specific clinical investigation, while the CER is a cumulative evaluation of all clinical data on a device, including literature, post-market data, and earlier studies. The CER is a living document updated periodically, and the CPSR serves as a key empirical input for this evaluation.

Is the lay summary subject to the same audit requirements as the main report?

Yes – despite its simplified format, the lay summary is a regulatory document and must be factually aligned with the full report. Notified bodies assess its compliance with MDR Article 77, clarity, audience-appropriate language, and absence of interpretative bias. Inconsistencies may lead to required revisions and delayed submission.

When is a clinical study report sufficient to support CE marking?

A CPSR can support CE marking if it complies with ISO 14155, MDR, and for IVDs, ISO 20916. Study results must be conclusive, endpoints met, and statistical analysis justified. The report must also include complete monitoring records, adverse event data, and demonstrate consistency with the approved protocol and supporting documents.