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The same professional title does not establish the same procedural experience in a multicentre device investigation. Compare sites using observable criteria for the tasks the investigation actually requires, alongside credentials and training attendance.
Define the assessment
Separate preparation, application, interpretation and responses to device problems. Identify which tasks belong to the investigator, technician or other appropriately qualified staff. A study-specific proficiency check is an operational tool; it does not itself grant professional authority or create an accredited qualification.
Worked example
For example, two sites will use the same imaging system. One team has experience with similar equipment, while the other is new to it. Both teams demonstrate preparation and image capture. The second receives further practice; the first still needs instruction on a different export workflow despite its clinical experience.
Practical checks
- Define acceptance criteria for each critical task and the qualifications of its assessor.
- Retain unsuccessful practice attempts rather than replacing their records with the final successful attempt.
- Consider reassessment when a new operator joins or a long interruption changes practical familiarity.
Decision and limitations
Readiness can be assessed when the record shows who can perform each critical task at each site. Differences in speed alone need not establish incompetence: equipment configuration, staffing and case mix may explain them. Link unresolved skills gaps to the activation decision and the proposed supervision arrangements.
Frequently asked questions
- Does every operator need identical training?
- The aim is comparable competence in common critical tasks. Training format and supervision may differ according to documented previous experience.
- Can proficiency testing replace credentials?
- No. Ability to perform a study task, professional authorisation and institutional permission are separate checks.