The document is designed to facilitate community reviews of clinical trials protocols and to ensure community participation in protocol development.
The Community Research Advisors Group (CRAG) created this Protocol Review Companion for Activists document to facilitate community reviews of clinical trials protocols and to ensure community participation in protocol development. The document suggests key questions to ask while reviewing the different sections found in most clinical trials protocols. The content reflects the CRAG's experience reviewing protocols for the Tuberculosis Trials Consortium, but the questions raised apply to community groups advising research institutions working on diseases other than TB. The document is designed to flag key considerations and highlight areas where community input is especially important. The questions can function as a checklist, or be used more informally to aid one's thinking when reading and commenting on a protocol.
The Companion can be downloaded from here.