ACRP-MDP case studies

ACRP-MDP · Put your knowledge to work in context.

The ACRP-MDP® (ACRP Medical Device Professional) is a specialty credential from the Association of Clinical Research Professionals that formally recognizes clinical research professionals with specialized knowledge in medical device clinical trials. It is aimed at practitioners who already hold an ACRP certification - CCRC®, CPI®, ACRP-CP®, or CCRA® - and want to demonstrate device-specific competence on top of their core credential. The ACRP-MDP case studies are 5 cases and about 3,045 words.

Enrollment Pressure and Eligibility Boundary in a First-in-Human Feasibility Trial

A sponsor is running a first-in-human feasibility study of an implantable neuromodulation lead under an investigational device exemption. The protocol requires participants to have failed at least two conservative therapies for chronic pain, a baseline pain score of 6 or higher on a 0-10 scale, and no prior spinal surgery at the target level.

592 words, about 3 min 2

Adverse Event Classification After a Device-Related Serious Event

During a multicenter trial of a vascular closure device, a participant develops a pseudoaneurysm requiring surgical repair three days after the index procedure. The site coordinator logs it as an adverse event, non-serious, 'unrelated to device, related to procedure.' The sponsor's medical monitor reviews it and believes it is serious (it required intervention to prevent impairment) and possibly device-related (deployment difficulty was noted in the case report form).

580 words, about 3 min 3

Informed Consent for a Vulnerable Population Under Time Pressure

A trial of a continuous glucose monitoring system seeks to enroll adults with type 1 diabetes, including those with mild cognitive impairment, at a site serving a large assisted-living population. The IRB approved a consent form at a 9th-grade reading level and requires a legally authorized representative (LAR) for participants unable to consent for themselves, plus re-consent if capacity changes.

591 words, about 3 min 4

Protocol Deviation, Device Deficiency, and the Amendment Decision

A 6-site trial of a wearable cardiac monitor has a protocol-specified visit window of +/- 7 days for the 30-day follow-up. At one site, 11 of 22 participants had their 30-day visit between 10 and 14 days late because the site's only trained coordinator was on extended leave and no backup was trained.

629 words, about 3 min 5

Monitoring Findings, Source Data, and the Escalation Ladder

A monitor conducting a routine visit at a site in a trial of an orthopedic implant finds: (1) source documents for 4 of 15 participants are missing the implant serial number, which the protocol requires to be recorded; (2) the site's delegation log does not list a study nurse who has been performing outcome assessments for three months; (3) the electronic case report form shows a pain score of 3 for one participant while the source shows 8, and the site cannot explain the discrepancy; (4) the site has not reported two adverse events to the sponsor within the protocol's 24-hour window. The site investigator is also the owner of the clinic and has a financial interest in the device's commercial success, which is disclosed in the trial's registry but not in the informed consent form.

653 words, about 3 min