NEWCASTLE CLINICAL TRIALS UNIT
STANDARD OPERATING PROCEDURES
SOP details
SOP title:
SOP number:
SOP category:
Clinical Study Report
TM-009
Trial Management
SOP history
Version number:
Version date:
Effective date:
Revision by date:
02
14th January 2014
13th February 2014
19th January 2016
SOP author details
Author name:
Author position:
Author signature:
Jennie Parker
Trial Manager
This electronic version is uncontrolled. The signed controlled copy is held in
the Newcastle Clinical Trials Unit Administration Office
Date:
SOP reviewer details
Reviewer name:
Reviewer position:
Reviewer signature:
Chris Speed
Senior Trial Manager
This electronic version is uncontrolled. The signed controlled copy is held in
the Newcastle Clinical Trials Unit Administration Office
Date:
SOP approver details
Approver name:
Approver position:
Approver signature:
Dr Jennifer Wilkinson
Senior Trial Manager, Newcastle Clinical Trials Unit
This electronic version is uncontrolled. The signed controlled copy is held in
the Newcastle Clinical Trials Unit Administration Office
Date:
STATEMENT
This is a controlled document. The master document is posted on the NCTU website:
http://www.ncl.ac.uk/nctu/
Any print-off of this document will be classed as uncontrolled. Researchers and their teams may
print off this document for training and reference purposes but are responsible for regularly
checking the NCTU website for more recent versions.
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SOP revision record
Version number
01
Date
1 March 2013
Reason for revision
Document release
02
14 Jan 2014
Document Revision
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1. BACKGROUND
Newcastle Clinical Trials Unit (NCTU) Standard Operating Procedures (SOPs 1) are designed to
ensure that clinical research and its supporting activities are conducted to the principles of Good
Clinical Practice (GCP)2,3,4. GCP is an international ethical and scientific quality standard for the
design, conduct, performance, monitoring, auditing, recording, analyses and reporting of trials
that involve the participation of human subjects. Compliance with GCP provides assurance that
the data and reported results are credible and accurate and that the rights, wellbeing and safety
of participants are protected.
2. PURPOSE
To report the results from a clinical trial. The results from the clinical studies are reported using
text and data with a level of detail ranging from informal to highly structured and
comprehensive, depending upon the individual trial requirements and the intended audience(s)
for the report.
3. SCOPE
This SOP system applies to all personnel carrying out clinical research, or related activities within
trials managed and/or monitored by the NCTU.
4. RESPONSIBLE PERSONNEL
The trial Sponsor or delegate shall provide a summary of the clinical trial report within one year
of the end of the trial to the main Research Ethics Committee and the Competent Authority of
the member State(s) concerned, in non-commercial research this is often delegated to the CI or
member of research team.
5. DEFINITIONS
CSR
Clinical Study Report
DMEC
Data Monitoring and Ethics Committee
GCP
Good Clinical Practice
ICH
International Conference on Harmonisation
NCTU
Newcastle Clinical Trials Unit
REC
Research Ethics Committee
SmPC
Summary of product Characteristics
TSC
Trial Steering Committee
6. PROCEDURE
6.1 Preparation, review and quality control of the analysis output
Data generated from the study are statistically analysed as detailed in the statistical analysis
plan and then presented as tables, figures and listings. Once written, the analysis output is
reviewed by the Clinical Study Report (CSR) author and other appropriate members of the
research team for accuracy. Any suggested changes will be incorporated if deemed
necessary.
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6.2 Format of the Clinical Study Report
The format of the CSR will either be defined as part of the study publication policy in the
Protocol or decided by the study team based on the type of study and the intended
recipients of the report. For some smaller studies, a report of the study published in a peer
reviewed journal may be sufficient while other studies may require a more formal
document.
6.3 Writing sections of the clinical study report
The author prepares sections of the CSR using the following inputs where appropriate:
 Proposal for funding

Protocol and protocol amendments

Statistical analysis plan

Case Report Forms (CRF)

Investigator brochure or Summary of Product Characteristics (SmPC)

References (including but not limited to those cited in the Protocol)

Tables, figures, listings and analysis output

Appendix materials

Safety database

Interim analysis (if applicable)
For efficiency, some sections of the CSR can be written before the final data analysis is
completed, this is sometimes referred to as the shell report. Sections of the shell report
usually include:
 Title

Synopsis

Table of Contents

Abbreviations and definitions of terms

Ethics

Study Structure

Introduction

Study Objectives

Investigational plan
Guidance to desirable CSR content can be found in International Conference on
Harmonisation (ICH) Topic E3, Guideline for Structure and Content of Clinical Study
Reports5. Some funding bodies may specify a specific CSR template to be used.
6.4 Clinical study report approval
The draft CSR must firstly be reviewed by the appropriate members of the study team (to
include the Chief Investigator (CI), Trial Manager and Statistician) and then by other
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reviewers (to include, Co-applicants, funders (and peer reviewers allocated by the funders),
Data Monitoring and Ethics Committee (DMEC) and Trial Steering Committee (TSC)
members) which will be specified in the publication policy section of the Protocol. If a
number of drafts are anticipated then these must be version controlled. Once all comments
have either been resolved or incorporated, the report is finalised.
6.5 Reporting to the regulatory authorities
The trial Sponsor or delegate shall provide a summary of the CSR within one year of the end
of the trial to the main Research Ethics Committee (REC)6 and the Competent Authority of
the member State(s) concerned. In non-commercial research this is often delegated to the
CI or member of research team. As a minimum, the summary CSR should include whether
the study achieved its objectives, the main findings and arrangements for publication or
dissemination of the research. Guidance for minimum report contents will be followed5,6.
7. REVIEW AND MONITORING OF THIS DOCUMENT
In accordance with NCTU policy NCTU: GE-001.
8. REFERENCES (hyperlinks verified on date published)
1. SOP NCTU:GE-001 – Standard Operating Procedure System
2. Medicines for Human Use (Clinical Trials) Regulations 2004, Schedule 1, Part 2 at:
http://www.legislation.gov.uk/uksi/2004/1031/contents/made.
3. The Medicines for Human Use (Clinical Trials) Amendment (No.1) Regulations SI (2006/1928)
at: http://www.legislation.gov.uk/uksi/2006/1928/contents/made.
4. The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations SI (2006/2984)
at: http://www.legislation.gov.uk/uksi/2006/2984/contents/made.
5. ICH Topic E3. Structure and Content of Clinical Study Reports at:
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC5000
02832.pdf.
6. NRES information ‘Final report on the research’ at:
http://www.nres.nhs.uk/applications/after-ethical-review/endofstudy/.
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