Clinical Study Report Shell: A

Clinical Study Report Shell

A Comprehensive Guide

The clinical study report is an essential part of the regulatory submission process. Its writing and finalization are important milestones. Company sponsors try their best to achieve this milestone as early as the availability of clinical study data (tables, listings, and figures [TLFs]) to meet the planned timelines of the drug development process. However, due to the uncertainty about the length of clinical study data, it becomes difficult to assess the exact time required to write and finalize a clinical study report. Therefore, to meet the planned timelines, the current industry practice is to split a clinical study report writing into two parts, i.e., shell writing (before the availability of clinical study data) and results writing (after the availability of clinical study data). The purpose of this blog is to enlighten the readers on clinical study report shell writing.

What is a Clinical Study Report Shell?

A shell is part of a clinical study report which is written after the completion of a clinical study at the site and before the availability of TLFs. Companies/ sponsors decide the limit of content that a shell contains, and it varies widely. This is communicated to the medical writer in a kickoff meeting, along with other requirements of the project. In the ICH E3 guideline sections, a shell can contain information in any of the two options given below:

  • All methodology information in Sections 1 to 9 and 15 to 16
  • All methodology information in Sections 1 to 9 and headings along with template text in Sections 10 to 16 (based on TLFs’ shell received from the sponsor)

This information is checked again and revised after the arrival of TLFs, which does not take much time.

Clinical Study Report

Which Documents Help in Clinical Study Report Shell Writing?

As the shell includes methodological and administrative information of the clinical study, the useful documents for writing the shell include:

  • Final protocol and amendments, if any
  • Statistical analysis plan
  • Details of administrative bodies (i.e., study sponsor, ethics committee, laboratories involved, and important study personnel)
  • Information about clinical study audit(s)
  • Notes to file
  • Clinical study report template (either an internal template or the sponsor’s provided template)
  • Style guide for writing (either an internal or sponsor-provided one)

What Points Should be Discussed with Sponsors before Shell Writing?

In the project kickoff meeting with the sponsor, the following questions should be clarified by the medical writer from the sponsor before beginning the shell writing:

  • Does the sponsor want the text in the shell to be verbatim from the final protocol (with a change in tense)? Or what is their viewpoint on modifying the text?
  • What is the sponsor’s expectation for Sections 10 to 16?
  • Will the sponsor provide TLFs’ shell?
  • How many appendices will the sponsor provide from Study Information (Section 16)?
  • How many review cycles will take place for shell writing? What is the duration of a review from the sponsor’s team?
  • When are the TLFs expected? Will they coincide with the shell review cycles?

Gaining the sponsor’s insight on the above questions will clarify expectations and deliveries between the sponsor and medical writer and help achieve the milestones on time.

Once the clinical study report shell has been locked, all the focus from the medical writer and sponsor’s team can be put on result writing after the arrival of TLFs.

 

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