EIT Health’s Venture Centre of Excellence Names ProductLife Group as Privileged Partner for Regulatory & ComplianceLearn More
ProductLife Group Announces Acquisition of Zwiers Regulatory Consultancy and Coverage Expansion to the NetherlandsLearn More
The Acquisition of Pharma IT Will Enable PLG to Strengthen its Foothold in Northern Europe and Offer New Services in the Context of Life Sciences DigitilisationLearn More
Pharma IT Solutions
Quality & Compliance
Safety & Vigilance
11 january 2023
Clinical Study Reports (CSR) are integrated reports of clinical studies for therapeutic, prophylactic, or diagnostic agents conducted in human subjects and the most crucial documents resulting from clinical trials.
CSRs are used for the following purposes:
The main points discussed in a CSR are:
Successful CSR completion requires information from the clinical trial protocol, statistical analysis plan/report, tables, listings, and figures obtained after statistical data analysis. Useful additional documents are the study reference manual, Investigator’s Brochure, imaging and/or operational manuals, depending on the trial.
Considering the recently released FDA pilot program to publish information from CSRs for transparency purposes, choosing the correct CSR type is of utmost relevance.
There are different types of CSRs:
Type 1: Full CSRs
Their purpose is to support approval by the regulatory agency and/or product label information. Full CSRs contain comprehensive clinical and statistical descriptions of the study conduct, and full output sections (efficacy, safety and, if applicable, PK/PD).
FDA, EMA, and PMDA all provided clear ICH E3 guidance on the structure and content of full CSRs.
Type 2: Abbreviated CSRs
These are condensed versions of full CSRs, evaluating whether the findings cast doubt on the safety claims and used for studies not intended to support the efficacy claim for the dose/regimen/population/indication. The structure and content of both abbreviated and synoptic CSRs (see below) are addressed in a specific FDA guidance, with abbreviated CSRs containing condensed study design/conduct, subjects, efficacy, and appendices sections, but including comprehensive safety.
An abbreviated CSR can be used for:
Type 3: Synoptic CSRs
Synoptic CSRs only contain an expanded synopsis with full safety data (or referenced publications), no in-text tables (unless the serious adverse events [SAEs] need one) and summarised disposition/clinical pharmacology/efficacy data.
Synoptic CSRs are acceptable for:
Type 4: Supplemental CSRs
Supplemental CSRs provide relevant safety and/or efficacy results from cross-study analyses or (un)planned analyses not completed in time to be included in the full CSR, which is generally referenced. While there are no dedicated guidelines, supplemental CSRs can follow the ICH E3 guideline, with its structure typically including an introduction, objectives, methods, results, and discussion sections.
Keen to know which type of CSR fits your study and need support with CSR authoring/review? We can support you!
Building on decades of experience in the EU and US regulatory requirements, ProductLife Group provides practical support, resources, and expertise for effective CSR writing.
Discover how ProductLife Group can support you on clinical trials application here and all AZ-regulatory services here.
* FDAAA 801, final rule of 2017 [42 CFR Part 11], Commission Guideline 2012/C 302/03)
Go to our Events to register
Go to our News to get insights