Case report forms confidentiality

AU the medical records of the subject should be available for comparison with the data recorded in the case report form (CRF). In the past, physicians have not allowed medical records to be available for the so-called source verification by non-physicians since they felt that this broke the strict confidentiality of the study subject s medical records. However, frequent mistakes in transferring important clinical data to the CRF, the recruitment of subjects who do not meet the inclusion and exclusion criteria and the occasional blatant fraud has led to an insistence by sponsors and regulatory agencies for sponsor s review of study documentation. Indeed, verification of source data cannot take place without access to the medical records of the study subject by the sponsor s staff. 

Case report form data are complete and can be verified with the source documents. Case report forms should be completed with a black ballpoint pen, and the print should be legible. Ensure that corrections, additions, or deletions are made, dated, and initialed by a member of the research staff authorized to initial CRF changes for the investigator. Laboratory parameters that have to be transcribed into the CRF must have each data point reviewed closely. Original reports (e.g., electrocardiogram, X-ray, Pap smears) should have copies made and inserted into the CRF. To maintain confidentiality, these reports need to have the subject s name blacked out, leaving only the initials visible. 

Setting up clinical studies is a lengthy process, as there are many documents to prepare [e.g. protocols and case report forms (CRFs)], study facilities to be assessed (e.g. study sites, CROs, clinical laboratories, phase I units), regulatory review to be considered and negotiations and agreements with study sites (e.g. contracts, finances, confidentiality, indemnity, insurance) to be undertaken. In addition, as will be dealt with in subsequent sections, ethical aspects of the study must be considered (e.g. ethics committee and IRB review and informed consent requirements), and study medications/devices must be organized. 

The Director-General shall prepare a report of the investigation which will state whether there has been a breach of confidentiality or a violation of the handling, protection, dissemination or release procedures for confidential information. The report will be prepared in two forms, a full form which sets out the facts determined in detail, and a modified form from which specific confidential material has been removed to ensure that confidential information connected with a breach is not further disclosed beyond its authorised scope of access, and to respect those elements of the privacy of individual staff members not relevant to the case. 

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