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The clinical study report is a document prepared for submitting clinical trial results to the regulatory authorities for product approval. This document is so crucial at each product development phase that the regulatory authorities make their sole decision to approve the product for further development or marketing based on the clinical study reports. This is because clinical study reports answer basic questions related to product development, such as:

As per the US FDA and CFR guidelines, clinical study reports are required to be submitted for each clinical trial. Therefore, these reports should present an adequate and well-controlled study by presenting details regarding study design, study conduct, and statistical analysis. These details help the regulatory authorities evaluate and determine the characteristics of a study.

As per 21 CFR 314.126, the characteristics of an adequate and well-controlled study include the following, which need to be presented in the clinical study report1:

Besides this, the ICH E3 clearly states to prepare and provide a clinical study report as per the ICH E3 guideline, whether the clinical study is completed or prematurely terminated.2

The clinical study report writing begins with writing a shell (methodology sections) with the help of source documents such as the study protocol, statistical analysis plan, randomization schedule, etc.3

After the arrival of tables, listings, and figures (TLFs), the rest of the sections containing results are written. The sections containing results are written after a thorough understanding of the study output. Most of the time, results for the overall study population and safety are written first for this purpose. Moreover, this enables the writer to know the safety issues that may have arisen and led to patient discontinuations or withdrawals. This is followed by writing efficacy and/or pharmacokinetics and/or pharmacodynamics sections.

Lastly, the discussion and conclusion sections are written. Both of these sections are written to justify the study objectives and endpoints.

The purpose of a clinical study report is to compile the clinical trial results into a single document and communicate them to the regulatory authorities. Eventually, the clinical study report becomes a part of the common technical document for an investigational product and helps in getting approval for marketing of the investigational product.

As per Appendix 16.1.5 of the ICH E3 guideline4, the principal or coordinating investigator(s) or sponsor’s responsible medical officer (depending on the regulatory authority’s requirement) signs the clinical study report. Further whoever signs the clinical study report confirms that they have read the report and confirms that to the best of their knowledge, it accurately describes the conduct and results of the study. In today’s scenario of the digital world, both handwritten signatures and digital signatures work for the signature page of clinical study reports.

There is guidance from the FDA on the use of electronic systems, electronic records, and electronic signatures in clinical investigations.5 As per this guidance, the FDA considers electronic signatures generally equivalent to paper records and handwritten signatures on paper only if electronic signatures and their associated electronic records meet the requirements of 21 CFR Part 11.

Clinical study reports are categorized based on the type of results they comprise. The FDA’s guidance on the Submission of Abbreviated Reports and Synopses in Support of Marketing Applications provides detailed information on these clinical study reports.6 Usually, full clinical study reports are submitted; however, abbreviated reports and synopses are submitted when full reports are not required and applicable. Below is detailed information on each type of clinical study report.

Full clinical study reports are submitted for studies that contribute to the effectiveness data as well as the safety data of the investigational product. The format and content to be used for these full study reports are clearly stated in the ICH E3 guideline.4 Full clinical study reports are also submitted for controlled studies that6:

It clinical study reports are submitted for studies that provide all the safety information of the investigational product; however, these reports do not aim to cast doubt about the effectiveness of the investigational product. Abbreviated clinical study reports are also submitted for studies that6:

Synoptic clinical study reports or synopsis are submitted for studies presenting safety data of the investigational product. The format of the synopsis remains the same as provided by the ICH E3 guideline. The synopsis is also submitted for studies that6:

The regulatory authority has guided the industry on each type of clinical study report. It is the sponsor’s decision about which clinical study report will fit best according to the type of study to submit to the regulatory authority. It is always a better approach to discuss the matter directly with the regulatory authority in advance to smooth the review process later.

  1. Code of Federal Regulation. Part 314.126 Adequate and well-controlled studies. ecfr.gov. Published 01 March 2017. Accessed August 29, 2023. https://www.ecfr.gov/current/title-21/section-314.126
  2. International Council for Harmonization. Integrated Addendum To ICH E6(R1): Guideline For Good Clinical Practice: E6(R2). database.ich.org. Published November 9, 2016. Accessed 29 August, 2023. https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
  3. Hamilton S. Effective authoring of clinical study reports: A companion guide. 2014; 23(2): 86-92. https://journal.emwa.org/regulatory-writing-basics/effective-authoring-of-clinical-study-reports-a-companion-guide/article/1681/2047480614z2e000000000211.pdf
  4. International Conference on Harmonization. Structure and content of clinical study reports E3. database.ich.org. Published 30 November, 1995. Accessed 29 August, 2023. https://database.ich.org/sites/default/files/E3_Guideline.pdf
  5. Food and Drug Administration. Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Guidance for Industry. fda.gov. Published March 2023. Accessed August 29, 2023. https://www.fda.gov/media/166215/download
  6. Food and Drug Administration. Submission of Abbreviated Reports and Synopses in Support of Marketing Applications Guidance for Industry. fda.gov Published August 1999. Accessed August 29, 2023. https://www.fda.gov/files/drugs/published/Submission-of-Abbreviated-Reports-and-Synopses-in-Support-of-Marketing-Applications..pdf

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