SOP 22 Case Report Form Design

SOP 330.01
Case Report Form Design
1.0
04/04/2008
Scope
This Standard Operating Procedure (SOP) has been written in order to conduct clinical
studies according to the International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice
(ICH-GCP) guidelines.
This SOP describes in particular the procedure of designing a Case Report Form (CRF).
This procedure applies to all CRFs of the trials sponsored by the European Group for
Blood and Marrow Transplantation (EBMT).
2.0
Abbreviations
CI
Coordinating Investigator
CRF
Case Report Form
CT
Clinical Trial
CTO
Clinical Trials Office
EBMT
European Group for Blood and Marrow Transplantation
GCP
Good Clinical Practice
ICH
International
Conference
on
Harmonisation
of
Technical
Requirements for Registration of Pharmaceuticals for Human Use
3.0
SF
Standard Form
SOP
Standard Operating Procedure
Responsibilities
CT Coordinator
Is responsible for the design and the EBMT layout of the CRF in
close collaboration with the Coordinating Investigator (CI) and the
database designer.
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SOP 330.01
Case Report Form Design
Database designer
04/04/2008
Is responsible for technical implementation of the CRF in the
database.
CI
Is responsible for ensuring that all trial hypotheses can be
answered from the data that is collected.
Senior CTO Staff
4.0
Is responsible for final CRF review.
Introduction
CRFs are used to collect the essential data for a clinical trial at the participating site. The
way they are designed is important as it must capture all the relevant data to answer the
trial hypotheses. The CRFs have to be as comprehensible as possible, to make it as easy
as possible for both site and EBMT staff.
5.0
Procedure
The CTO staff must use the CRF template (SF 330.1) as a base. The CRF template
consists of questions that can be asked for in EBMT studies. The template is updated
when there is the need to do so, for instance when standard procedures in treatment or
diagnostic tools change. The CRF template consists of a number of separate sections, in
order for the forms to be as simple as possible and to ensure consistency: for instance a
haematology section, a biochemistry section, a transplant section, etc. The sections are
then put in the final CRF at the appropriate place(s). Certain sections will be used at
multiple time points, while others may only be used once.
The CT coordinator adjusts the CRF template to mimic the protocol and capture all the
protocol-specific necessary items. Due to the nature of clinical trials, new methods and
questions may arise in a clinical trial. In this case additional questions are inserted into
the CRF template using a similar layout. He sends this draft to the CI, the database
designer and a senior member of CTO staff and processes all their comments. This
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SOP 330.01
Case Report Form Design
04/04/2008
process is repeated until the CI and the database designer have no more comments. Then
a final layout is made and, after notification of the CI, dispatched to the participating
sites.
6.0
7.0
References
-
ICH Harmonised Tripartite Guideline for Good Clinical Practice 1996
-
EU Clinical Trials Directives2001/20/EC and 2004/28/EC
Appendices
Appendix A: SF 330.1 CRF template
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