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. This SOP describes in particular the procedure of validating data on a Case Report Form (CRF). This procedure applies to all data on CRFs of the trials managed through one of the clinical trials offices (CTO) of the European Group for Blood and Marrow Transplantation (EBMT). 2.0 Abbreviations CRF CT CTO DQF DVP EBMT GCP ICH PI SF SOP WI Case Report Form Clinical Trial Clinical Trials Office Data Query Form Data Validation Plan 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 Form Standard Operating Procedure Work Instruction page 2 of 5

3 3.0 Responsibilities Director CT Is responsible for overall guidelines with respect to quality, quality control, and areas of focus per protocol. CT Coordinator Is responsible for the development of a data validation plan (DVP) and performing the validation. PI Is responsible for answering all queries originating from any validation. Database designer Is responsible for programming and implementing of quality checks. 4.0 Introduction The starting point to ensure that analyses are correct is ensuring that quality of data is as high as can be achieved. In order to achieve this SOPs or Work Instructions (WIs) have to be followed. Validation is essential to ensure completeness and correctness in order to preserve the integrity of trial data and the quality of the investigation. 5.0 Procedure Essential data must be verified. For this purpose various manual and electronic checks are performed according to the DVP. page 3 of 5

4 5.1 Data Validation Plan The CT coordinator produces a DVP before the validation commences, the DVP can be created before data entry of a trial starts. He must review both the protocol and the CRF and register relevant and appropriate checks for data fields in the DVP. For an example of a standard DVP: see appendix A (SF Data Validation Plan). 5.2 Testing of the checks To test all checks the CT coordinator must create dummy CRFs with fictional (erroneous) data. One dummy CRF must have all data correct to function as negative control. He denotes on the DVP which dummy CRFs must return specific error messages. After entering the dummy CRFs (preferably in a test environment of the database) and performing the validation the dummy CRFs are checked if they return the expected specific error messages according to the DVP. The correct dummy is checked and must not return error messages. Each dummy CRF will be allocated a number as follows. If the patient number has 3 digits then the correct dummy CRF will be numbered 990. The erroneous dummy CRFs will be numbered 999, 998, etc (as required). If the patient number has 4 digits then the correct dummy CRF will be numbered The erroneous dummy CRFs will be numbered 9999, 9998, etc (as required). 5.3 Validation The validation is carried out upon completion of data entry of trial data for one or more (or parts of) CRFs. In case of missing data or error messages which are not solvable at the trials office (e.g. discrepancies) the CT coordinator poses queries to the site by use of a Data Query Form (DQF). For an example of a DQF: see appendix B. Records must be kept of all query requests that are sent out. If the page 4 of 5

5 discrepancy is not solved after receiving the answer from the site, the CT coordinator poses a re-query until the discrepancy is resolved and/or clarified. 5.4 Data Query Form All queries are sent to the site using a DQF. Queries that don t result in any change of the CRF are answered on the DQF. An indication must be made on the DQF if a query does require some change of or addition to the CRF. Before making a change in the CRF as a result of a query, the site must copy their latest version of the CRF. Changes must be made on this copy of the CRF. This updated copy can be faxed or mailed to the CTO. Before mailing the updated CRF to the CTO, the site must keep a copy for their own reference. The updated CRF page(s) are placed in the patient file along with relevant correspondence. 6.0 References - ICH Harmonised Tripartite Guideline for Good Clinical Practice EU Clinical Trials Directives2001/20/EC and 2004/28/EC 7.0 Appendices Appendix A: SF Data Validation Plan Appendix B: Example of a Data Query Form page 5 of 5