Home Forums General Discussion Forum IBC TMF Filing Reply To: IBC TMF Filing

Kathie Clark

Wouldn’t these fall under committees? There are a number of artifacts in this zone and section:

01 Trial Management 01.03 Trial Committee 01.03.01

For example, the Committee Process artifact says:

To describe the purpose and mode of operation/manner of working of the Independent Trial Committee, which may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data and the critical efficacy endpoints and to recommend to the sponsor whether to continue, modify or stop a trial. To describe in advance the decision-making process of the Committee that will evaluate key trial events (e.g. endpoints).

Committee Types may include but not limited to: DMC, DSMB, National, Steering, Scientific, Internal DMC, Device, Dose Escalation, Safety Evaluation, Adjudication, Clinical Events Coordination. These may be used as sub-artifacts or metadata. Applies to all Committee artifacts