SOP 22 Case Report Form Design
Transcription
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. Page 2 of 4 RED INK ORIGINAL 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 Page 3 of 4 RED INK ORIGINAL 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 Page 4 of 4 RED INK ORIGINAL