Source data verification

Inspectors will visit the investigator site and may possibly wish to visit the sponsor s office. They will review the documentation of the study file (see Box 7.1). Approval documents of the lEC will be compared with any amendments made to the protocol or to the subject s information sheet/ICR Consent forms for the study subjects will be inspected to establish who actually gave consent and whether this was before entry into the clinical study. A thorough source data verification of the CRF with the source documents, including the medical records, will be undertaken. Documentation relating to drug accormtability wiU be matched with each subject s CRF The facilities wiU be reviewed and the site staff interviewed. Further information can be obtained from... 

Monitor means one or more persons appointed by the Sponsor to monitor compliance of the Clinical Trial with ICH GCP and to conduct source data verification. 

The aim of this chapter is to describe the general framework for conducting good clinical practices (GCP)-compliant clinical research. As it is difficult to cover this broad topic in such a short chapter, the authors will focus on those areas that are most discussed, most problematic and most critical to achieving a GCP-compliant clinical study. Thus, there is particular emphasis on ethical issues, source data verification and data integrity, monitoring and safety review, and study medication/device management. 

Source data verification is the process of verifying CRF entries against data in the source documents. Source data verification is only carried out at the study site, usually by the sponsor/CRO monitor (auditors will also conduct source data verification on a sample of CRFs inspectors may conduct source data verification on a sample or all CRFs). 

For all study subjects, source data verification requires a review of the following items ... 

Recording audit observations is an essential part of the audit to enable the auditor to prepare detailed, accurate and complete audit reports which are based on factual observations. Checklists, audit questionnaires and sampling plans are useful tools and should be prepared prior to the audit. Generic checklists may be a good start and can be refined as required for each audit to account for trial-specific issues. Source data verification (SDV) templates are always trial-specific as each clinical trial is unique. Although checklists and questionnaires are very useful to record audit observations, they should never restrict the extent and scope of audit activities and allow for flexibility during the audit. 

Chinese clinicians have the same competencies as any elsewhere in the world, but possibly few have any experience of working to GCP standards, and the administrators of hospitals are also not familiar with the concept. Thus, much time and energy needs to be directed at the training of investigators and those with power to sell the concept of source data verification, and such a task must be done by a Chinese speaker because of the subtlety of the alphabet and the risk of misunderstanding. 

The CRO should have a written set of SOPs concerning the visit procedures, extent of source data verification, drug accountability and adherence to the protocol. 

Based on Step 4 of the ICH Good Clinical Practice (GCP) guideline of May 1996, the Japanese Ministry of Health and Welfare (MHW) prepared an amendment to the previous GCP guideline and on 27 March 1997 this was issued as MHW Ordinance of the Standards for Good Clinical Practice . This new GCP became effective as of 1 April 1997 with some moratoria (preparation of standard operating procedures (SOP) at medical institutes, source data verification, etc.), and full implementation was from 1 April 1998. Unlike the previous GCP guidelines, the new GCP is based on the revised Pharmaceutical Affairs Law of June 1996, which requires... 

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