Clinical Research

Relevant materials may include approved consent forms, consent documentation, institutional review board records, protocol versions, participant information, correspondence, and records showing when study procedures occurred. These materials can help establish which consent documents and protocol versions were in effect, what the records document about the consent process, and whether the documented sequence of research activities is consistent with the study record. The records should be evaluated in light of any applicable waiver, alteration, or other consent requirements.

Questions can arise when source documentation, case report forms, electronic study records, corrections, missing information, or reported results do not align. An appropriately qualified clinical research expert can trace how study data were generated, entered, transferred, modified, and reported, to the extent the available records, metadata, and audit trails permit; examine documented changes or discrepancies; and assess whether the available records support the reported study conduct. Specialized statistical analysis of the resulting dataset may require a Biostatistics expert.

Clinical research is broader than clinical trials and can include observational studies and other research involving human participants. Clinical Trials more specifically concerns studies in which participants are prospectively assigned to interventions to evaluate health-related outcomes. Because clinical trials are a subset of clinical research, the two areas can overlap. When a dispute centers on trial-specific design, administration, investigational products, or trial operations, the retained Clinical Trials Expertise may be more specific. Broader questions about research documentation, participant protections, study conduct, and clinical research practices can fall within Clinical Research, depending on the technical issue and the expert's qualifications.