1.0 Scope. 2.0 Abbreviations

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2 1.0 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. The purpose of this SOP is to ensure that all centre personnel, participating in a clinical trial or audit, co-ordinated by a European Group for Blood and Marrow Transplantation (EBMT) Clinical Trials Office (CTO) is provided with, and follow the same general instructions for Case Report Form (CRF) completion. The CRF is used to capture all of the essential trial data and is customised for each study to record study specific data. 2.0 Abbreviations CIC CRF CTO EBMT GCP ICH PI SOP Centre Identification Code Case Report Form Clinical Trials Office European Group for Blood and Marrow Transplantation Good Clinical Practice International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Principal Investigator Standard Operating Procedure page 2 of 6

3 3.0 Responsibilities Principal Investigator (PI) Must verify the data entered into the CRFs. Site Staff Must complete CRFs legibly, accurately, and according to specified timelines. 4.0 Introduction After CRFs are completed original pages must be sent to the relevant EBMT CTO (unless stated otherwise in the protocol). Copies must be kept on site and filed as stated in the protocol. 5.0 Procedure 5.1 Entering Data Site staff must ensure that they have signed the Delegation Log in the Site File before entering data into a CRF and must ensure that the EBMT Trials Office has a copy of the Log. All data must be entered using a black ballpoint pen. Pencil /coloured pens must not be used. All data entered must be clear and legible. Acronyms and abbreviations must be avoided unless previously agreed and documented. page 3 of 6

4 The study site and patient identifiers (eg: patient initials, EBMT CIC Number, trial number) must be entered onto all CRF pages. When entering patient initials, a dash must be used if there is no middle initial, eg: J R. All sections must be completed. No spaces or boxes must be left blank. If necessary, a leading 0 can be used to ensure that all boxes are filled. For example: Weight: 0 7 kgs. 6 Dates must be entered in the format stated in the CRF. When entering dates, NK must be entered if one field is not known. For example: where the day is not known but the month and year are = NK / 04 / If information is missing, the following abbreviations must be used: NA not applicable ND not done (a comment may be required as explanation) NK not known All laboratory results must be entered in the units specified in the CRF. The information entered into the CRF must be the same as the information on the source document, unless the data has to be re-formulated, for example, laboratory results. page 4 of 6

5 5.2 Correcting Errors To make a correction, draw a single line through the incorrect item and write the correct information next to the error. All corrections must be initialled and dated and an explanation for the change may be needed GB 01/06/07 If multiple corrections are made on a CRF page, it is possible to sign and date once after stating how many corrections have been made on that page. If corrections are not initialled and dated, the CT Coordinator must contact the site and request a copy of the relevant page(s) with the changes initialled and dated. If corrections are made to a CRF page that has already been sent to the CTO, the original page must be photocopied first and the corrections must be made on the photocopy. Then the page must be photocopied again in order to retain a copy at site. The corrected CRF must be sent to the CTO. Instructions for sites to respond to data query requests must include not to use correction fluid (e.g. Tippex), not to obscure the original data entry and to initial and date any corrections made. 5.3 Checking Data CRF pages must be checked by the study site to ensure that the data is complete and accurate before sending them to the EBMT Trials Office. Ensure that the CRFs are signed and dated where required. page 5 of 6

6 6.0 References - ICH Harmonised Tripartite Guideline for Good Clinical Practice ICH GCP Guidelines Section 4.9 Record and Reports : 4.9.1, and EU Clinical Trials Directives2001/20/EC and 2004/28/EC 7.0 Appendices Not applicable page 6 of 6