Clinical Investigation Plan (CIP)
The Clinical Investigation plan functions as documentation of clinical trials for medical devices. The documentation is identical to that of clinical trials of medicinal products. Before the start of the clinical study, the Federal Institute for Drugs and Medical Devices must approve the CIP. The ethics committee must also give its approval. The content of the CIP is defined by DIN EN ISO 14155. This means that the objective of the clinical trial must be defined, the study design must be disclosed, and the conduct as well as data collection and follow-up of the subjects must be clearly evident. In addition, statistics and comprehensive monitoring are required. If decisive changes are subsequently made to the Clinical Investigation Plan, these must again be approved by the Federal Institute for Drugs and Medical Devices (BfArM) and the relevant ethics committee.