A key aspect of clinical development and clinical trial operational success is getting the data right. Dr Michael Silverman, principal at BioStrategics Consulting Ltd., discusses the importance of the Case Report Form and Clinical Monitoring to ensure the quality of data acquisition.
Over the last two weeks I discussed clinical trial operational success from the viewpoint of Getting the Right Data, which involves site selection, clinical assessments, laboratory procedures, clinical supplies and biological specimens. Over the next two weeks, I would like to change directions to discuss Getting the Data Right, which encompasses Case Report Form (CRF) design, clinical monitoring, data entry and management, statistical programming and analysis and quality assurance. This week will concentrate on Case Report Form Design and Clinical Monitoring.
Case Report Form Design
The case report form (CRF) is the data capture tool of record for any industry-sponsored clinical trial. The CRF must be thoughtfully created to gather all relevant trial information as it becomes the basis for the evolving electronic database. As such, many team members must participate in its development; clinicians with their understanding of the nature and flow of clinical procedures; data managers, with their perspective on the creation of a useful, high quality database; and biostatisticians, with a view toward meaningful data presentations and analyses.
Lack of attention to CRF design can be a critical lapse with far reaching downstream reverberations. In a study I was involved with sometime back investigating a treatment for cervical dysplasia, the CRF contained a field to capture post treatment cervical histology, but restricted the entries to abnormal results only and would not allow for tissue that was normal to be recorded. Several patients actually finished the study with normal histology, yet there was no CRF field for recording such data. As a result, the final database never listed the normal results, generating endless confusion and almost leading observers to erroneously conclude that the desired result of “normal” had never been observed.
Clinical monitors (or clinical research associates [CRAs]) are the linchpins of efforts to ensure data integrity. They are the only professionals in the position to compare the sponsor’s records (i.e., the CRF) to source documentation; to constantly monitor adherence to regulatory and ethical principles; and, in countless other ways, to ensure compliance of study procedures with Good Clinical Practices. At all steps of the data retrieval process, the highest value is placed on accuracy, honesty, and attention to detail. The clinical monitor carries that message to the world outside of the investigative site.
A well thought through Case Report Form and well trained and experienced clinical monitors are critical to ensuring you get the data right and go on to completing a successful clinical study.
Dr Michael Silverman is the principal clinical consultant at BioStrategics Consulting Ltd., a clinical development consulting company based in Marblehead, MA, with business interests around the globe. Dr Silverman would be delighted to hear your thoughts on today’s blog, your experiences, or anecdotes and of course, your questions. To make comments or ask questions, click on this link.
FREE BIOSTRATEGIC GUIDANCE DOCUMENTS AVAILABLE:
- THE CLINICAL TRIAL PROTOCOL GUIDE
- CLINICAL DEVELOPMENT PLAN GUIDE
- THE PROSPECTIVE PATIENT PACKAGE INSERT
BioStrategics Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical, biotechnology and medical device industries, including: Clinical development strategy and management, conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials, IND planning and preparation, FDA and other regulatory authority submissions, meetings, and related interactions, Clinical strategic planning for small molecules, biotechnology products, immunotherapeutic agents, novel drug delivery technologies, and medical devices in virtually all therapeutic areas, New technology assessment, due diligence, and program planning, Clinical development advisory services to senior-level management (CEO, COO, CSO, BOD).
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