Clinical investigation plan (CIP)

The plan is the reference against which the study is run and audited. Changes after approval usually need a formal amendment, so getting endpoints and statistics right before submission saves time later.

‘clinical investigation plan’ means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;

EU MDR, Article 2(47)

document that states the rationale, objectives (3.37), design and pre-specified analysis, methodology, organization, monitoring (3.35), conduct and record-keeping of the clinical investigation (3.8) Note 1 to entry: For the purpose of this document “protocol” is synonymous with “CIP.” However, protocol has many different meanings, some not related to clinical investigation, and these can differ from country to country. Therefore, the term CIP is used in this document.

ISO 14155:2020, clause 3.9