Working with disclosure managers

Disclosure managers work with writers to prepare clinical study information for public disclosure.

Disclosure managers, also called data transparency specialists, bridge regulatory clinical research and the public. ¹ They work throughout a study's lifecycle, from protocol draft to sharing individual patient data, and collaborate with medical writers, trial leads, statisticians, programmers, regulatory affairs specialists, pharmacologists and patent attorneys. ²

Before protocols and reports are finalised, disclosure managers work with medical writers and others to ensure that the documents are ready for public registries and that structured data are properly disclosed. ² Their checks include whether disclosed endpoints match study objectives, study synopses meet regulatory requirements and adverse-event reporting is properly implemented. ³ Disclosure managers’ input while documents are still in draft prevents multiple revisions and review rounds. ³ Successful disclosure requires strong communication between transparency specialists, medical writers and other stakeholders. ⁴