5.2 Device Instructions, Configuration and Training

Device Instructions, Configuration and Training

The CCRA ECO explicitly includes the Investigator's Brochure and investigational-device instructions for use. The common skill is translating current product information into safe, reproducible trial conduct. A brochure stored in a binder is insufficient if staff use a different model, obsolete instructions or a configuration that does not match the protocol. Review the product's identity, version, intended trial use and required preparation before evaluating apparent compliance.

For a medicinal product, the IB summarises relevant nonclinical and clinical experience and provides guidance for investigators. For a device, instructions may specify setup, configuration, operation, precautions and handling. Do not assume that an investigational device uses the drug-development phase labels or that ICH supplies every device-specific technical requirement. The trial protocol, applicable product instructions and requirements define the actual activity.

A document-to-practice verification chain

1. Identify the product/model, formulation or configuration used by the site.
2. Confirm the current applicable protocol and product-information version.
3. Verify who performs the task and their relevant training or certification.
4. Observe or review evidence of the actual workflow, within authorised monitoring scope.
5. Compare the resulting records, product traceability and any reported problems.
6. Escalate mismatches and preserve the evidence supporting the assessment.

A product update can affect several controls at once. A new setup instruction may require staff training and a revised checklist. A newly identified risk can require urgent communication, protocol evaluation and updated consent. A revised storage instruction can affect shipping and pharmacy records. The monitor should trace these consequences rather than merely obtaining a receipt signature.

Model and software configuration

Suppose the study uses a diagnostic device with a specified software algorithm. A site installs a newer commercial software release because it appears to improve performance. Even if the display looks familiar, the change could affect endpoint calculation, data format, compatibility or calibration. Identify the installed version, when the change occurred and affected assessments. Notify the sponsor's responsible technical/clinical function and follow the controlled evaluation process.

Do not tell staff to uninstall the software immediately without considering clinical safety and data preservation. Retain configuration and change records, original outputs and relevant metadata. The sponsor needs to assess comparability, participant impact, whether repeat assessments are appropriate and whether any amendment or reporting is needed. Repeating a measurement later cannot recreate the original time point.

Operator training and competency

Training should address the activity the person actually performs. Reading a general GCP certificate does not establish competence to operate a specialised device or score an imaging outcome. Verify required task training, a usable instruction set and access to technical support. If the protocol requires rater or operator certification, establish that it was current before the affected assessments and determine how staff turnover is managed.

A training log can document attendance while leaving understanding uncertain. A practical demonstration, supervised run or review of initial outputs may be appropriate to the task. The monitor does not invent a universal competency exam; they verify the plan and escalate evidence that it does not control a critical process adequately. Confirm that delegated personnel understand how to recognise and communicate a malfunction or clinically significant result.

Traceability and problems without injury

Track the identifiers required by the trial: model, batch, serial number, kit or configuration, use dates and participant code as relevant. Not every study uses the same identifier scheme. The purpose is to reconstruct which participant encountered which product and to act on a defect, recall or safety concern. Keep unused, returned, damaged and used supplies distinguishable.

A malfunction or use error can matter even when the participant was unharmed. A clinician's successful intervention may have prevented an adverse outcome. Document the facts and clinical assessment, use the trial's escalation process and preserve relevant product evidence. Do not assign a universal national device classification or reporting deadline from a generic vignette. Do not clean, discard or modify a retrieved product contrary to the investigation instructions.

A monitoring scenario

A device-use log lists model A for a participant, while the procedure record lists model B. The operator says the two are equivalent. The CRA should examine shipment/accountability records, packaging identifiers, procedure evidence and configuration history, then seek qualified clarification. If model B was used, determine whether it was permitted and evaluate the impact through the sponsor and investigator. If the log contains a transcription error, correct it traceably with supporting evidence.

Both routes preserve the original entry and the reason for correction. Neither involves changing every record to the model that would make the case compliant. This is the same reasoning used for an IB update or a medicinal-product kit discrepancy: identify the applicable instructions, establish what happened, protect participants, and document the evaluated response.

Official sources

Checked October 18, 2026: ICH E6(R3), Principles and Annex 1, ICH E9, ICH E9(R1), ICH E8(R1).