Identifying critical suppliers of trial services

Procedure Author

Investigators who retain the services of individuals or parties to perform trial-related duties and functions must ensure they are adequately qualified and implement procedures to ensure the integrity of the duties/functions performed and any data generated. This procedure therefore describes how critical service providers (suppliers/vendors) are identified, selected and managed to ensure they are suitably qualified, skilled, experienced or otherwise able to provide the quality of service required for a clinical trial. This includes service providers such as laboratories, caterers, consultants (e.g. specialists, quality assurance or regulatory professionals, data management companies etc.).