ACRP-MDP common mistakes
ACRP-MDP · Understand the traps and how to avoid them.
Answering questions about the sponsor's oversight duties by describing the site investigator's tasks (or vice versa), e.g., selecting 'ensure informed consent is obtained' as the sponsor's responsibility.
Candidates memorize a single blended list of 'trial activities' and never sort them by role, so they default to whichever activity sounds most clinical or most familiar.
What to do instead
Build a two-column role matrix (sponsor / investigator-site / IRB-EC / monitor-CRO) and force yourself to place each activity before answering; on the exam, first ask 'who is the actor in this question stem?' and eliminate options belonging to another actor even if factually true.
Treating ISO 14155 as interchangeable with ICH E6(R2/R3) GCP and choosing an answer that cites the wrong framework's terminology (e.g., 'sponsor-investigator', 'coordinating investigator' vs. 'principal investigator').
Most candidates study ICH-GCP for drug trials first and assume the concepts map one-to-one; ISO 14155 has device-specific roles, definitions, and requirements that differ in wording and emphasis.
What to do instead
Maintain a short glossary card of ISO 14155-specific terms (investigator, sponsor, sponsor-investigator, monitor, clinical investigation plan, clinical investigation report, adverse device effect, serious adverse device effect, device deficiency) and for each exam option ask 'is this the ISO term or the ICH term?' before selecting.
Classifying an event as an 'adverse event' when the scenario describes a device deficiency, or vice versa, and missing that a device deficiency can exist with no patient harm.
Candidates conflate 'something went wrong with the patient' with 'something went wrong with the device'; the device-specific vocabulary (deficiency, malfunction, use error, inadequate labelling) is less familiar than the drug-trial AE construct.
What to do instead
Drill the distinction explicitly: an AE is harm/injury to a participant; a device deficiency is inadequacy in identity, quality, durability, reliability, safety, effectiveness, or performance, including malfunction, use error, or labelling problems. Practice sorting 20 short vignettes into AE / SADE / device deficiency / none, and note that a deficiency without harm is still reportable per the CIP.
Selecting the 'most cautious' option on risk-management and monitoring questions (e.g., 'report everything to the IRB immediately', '100% source data verification on all subjects') instead of the risk-proportionate answer.
Candidates substitute general conservatism for the risk-based, proportionate approach that device GCP and modern monitoring guidance actually require; 'more oversight is always better' feels safe.
What to do instead
Anchor every monitoring/oversight question to the risk-based principle: the correct answer is the one proportionate to the risk of the device and the trial, documented in the CIP or monitoring plan. When two answers both seem safe, choose the one tied to a documented, risk-proportionate plan rather than the one that escalates everything uniformly.
Getting informed-consent edge cases wrong: assuming re-consent is never needed after a protocol/CIP amendment, or that a legally authorized representative's consent is always acceptable regardless of jurisdictional or CIP requirements.
Candidates learn the general elements of consent but not the trigger conditions for re-consent (new risk information, changed procedures, new device information) or the conditions under which surrogate consent is permitted.
What to do instead
Memorize the re-consent triggers as a checklist (new or increased risk, significant changes to procedures or device information, changes that may affect the subject's willingness to continue) and always tie LAR/emergency-consent answers to what the CIP and applicable local requirements permit, not to a blanket rule.
Misidentifying the correct reporting pathway and timeline for a serious adverse device effect (e.g., sending it to the IRB/EC only, or missing the sponsor and, where required, competent-authority notification).
Candidates learn 'report SAEs' as a single action and do not distinguish who reports what to whom and by when for device trials, including the investigator-to-sponsor promptness expectation and the sponsor's onward regulatory reporting.
What to do instead
Draw a reporting map: investigator notifies sponsor without unjustified delay (and IRB/EC per local requirements); sponsor evaluates causality and reports to regulatory authorities per applicable requirements and timelines, and informs all investigators as required. For each practice question, identify the actor first, then the recipient, then the timeline.
Confusing the roles and independence requirements of the IRB/EC versus the sponsor's monitoring and data oversight functions, e.g., assuming the IRB approves the monitoring plan or that the monitor grants ethics approval.
Oversight bodies all sound like 'reviewers', so candidates collapse them into one gatekeeping function and pick answers that mix their authorities.
What to do instead
Write one sentence per body describing its authority: IRB/EC approves the investigation and consent materials and reviews safety information; the sponsor designs, conducts, and monitors; the monitor verifies compliance and source data; a data oversight committee (where used) reviews aggregate safety/efficacy data. Reject any option that gives one body another's authority.
Missing device accountability and traceability specifics, such as failing to recognize that investigational device shipment, receipt, storage, dispensing/use, return, and destruction must be documented and reconciled.
Candidates over-generalize from drug accountability and overlook device-specific traceability (serial/lot numbers, device history, return or disposal of unused devices) and the documentation chain the CIP requires.
What to do instead
Build a device accountability checklist (shipment record, receipt, storage conditions, issuance/use by subject with unique identifier, return/disposal, reconciliation, documented delegation) and for any question about 'what must be documented' look for the option that preserves the full traceable chain including unique device identifiers.
Answering protocol-deviation questions by choosing 'document only' or 'immediately withdraw the subject' rather than assessing significance and following the CIP's deviation-handling and reporting requirements.
Candidates treat deviations as either trivial paperwork or catastrophic events, missing the middle ground of assessing impact on subject safety, rights, and data integrity and reporting significant deviations per the CIP and local requirements.
What to do instead
Use a three-step decision routine: (1) does it affect subject safety, rights, or data integrity? (2) does the CIP or local requirement define it as significant and specify reporting to sponsor/IRB/EC? (3) what corrective and preventive action is documented? Choose the answer that reflects assessment plus documented action, not a reflex to document or withdraw.
Assuming the Clinical Investigation Plan and the Clinical Investigation Report contents are interchangeable with a drug protocol and clinical study report, and picking answers that omit device-specific elements (e.g., device description, intended use, risk analysis, handling and accountability, training requirements).
Candidates study report/protocol structure from the drug paradigm and do not internalize the device-specific content that ISO 14155 expects in the CIP and CIR.
What to do instead
Create a CIP/CIR content checklist from the device perspective (device description and intended use, risk analysis and mitigation, subject selection, endpoints, statistical considerations, monitoring, device accountability, deviation handling, safety reporting, and in the CIR the device performance and safety conclusions). When an option omits a device-specific element, treat it as incomplete.