ACRP-MDP study plan

Draft a one-page map of the medical device development lifecycle from concept through post-market surveillance, labeling each phase with its governing purpose

Define and contrast the roles of sponsor, monitor, clinical investigator, and site staff in device trials, writing a short comparison table from memory

List the major device classification frameworks and explain in writing how risk class drives trial evidence requirements

Build a personal glossary of 25 core device research terms with your own definitions, flagging any you cannot define confidently

Explain in writing how a device's risk determination shapes the clinical investigation plan and the level of evidence required

Summarize the purpose and required contents of an investigator's brochure or device manual without consulting notes

Describe how preclinical and bench testing feed into the decision to begin a clinical investigation

Distinguish intended use, indications for use, and contraindications using three original examples

Outline the elements of a clinical investigation plan and state the purpose of each element in your own words

Explain the informed consent process for device trials, including what must be disclosed about device-specific risks

Describe safety reporting pathways for device-related adverse events and device deficiencies, distinguishing the two

Identify the records a site must maintain and explain the rationale for each

Bridge from domain 1 to domain 2 by writing how ICH and ISO 14155 principles map onto the CIP elements you outlined

State the core ethical principles underlying human subject protection and connect each to a concrete trial safeguard

Explain the purpose of a trial master file and describe what belongs in it

Self-quiz on domain 1 material and log every item you miss into a running error log

Summarize the scope and structure of ISO 14155 and explain how it governs device trial conduct

Describe how ICH good clinical practice principles apply to device investigations and where device-specific guidance adds requirements

Explain the roles and responsibilities of sponsor, monitor, and investigator as set out in the standards, citing the concept rather than the clause number

Draft a monitoring visit flow from preparation through close-out

Explain the risk-based monitoring approach and justify how monitoring intensity should scale with trial risk

Describe source document verification, what it confirms, and common findings it surfaces

Outline deviation and noncompliance handling from detection through corrective action

Explain how protocol deviations are classified and what triggers escalation

Describe the essential elements of informed consent under the standards and identify common consent deficiencies

Explain safety reporting timelines and the investigator's and sponsor's respective obligations

Summarize requirements for statistical considerations and how the analysis population is defined

Explain the purpose and process of site close-out and record retention

Re-quiz on your full error log and confirm every previously missed item is now answered correctly

Complete a timed mixed-domain practice set and analyze misses by domain to target final review

Teach two concepts aloud from each domain as if explaining to a new coordinator

Build a one-page exam-day sheet of the highest-yield concepts you keep missing