CRA (OPS) case studies
CRA · Put your knowledge to work in context.
The Clinical Research Associate (CRA) certification is a professional credential for monitors who oversee clinical trials at investigative sites on behalf of sponsors and contract research organizations. It signals that a monitor can independently verify that a study is conducted according to protocol, good clinical practice, and applicable regulations, and that subject rights and data integrity are protected. The CRA case studies are 5 cases and about 3,485 words.
1The 24-Hour Clock That Started on a Friday
A Phase II oncology study is enrolling at a community site. On Friday 14 March, sub-investigator Dr.
726 words, about 4 min2A Refrigerator Door Left Ajar Over the Weekend
At a Phase III site, a continuous temperature logger in the investigational pharmacy refrigerator shows readings between 2.0 and 8.0 C for most of the study, but a spike to 14.6 C lasting 5 hours 40 minutes on Saturday 8 February. The refrigerator door had been left ajar by weekend cleaning staff.
665 words, about 3 min3The Note Written in Different Ink
During a monitoring visit at a three-investigator site, the CRA compares source with EDC for subject 07-003. The 4 February source entry reads blood pressure 148/92 mmHg; EDC shows 128/92.
702 words, about 4 min4Twenty Copies of the Superseded Consent Form
A site's IRB approved informed consent form v4.0 on 2 May, with a memo stating that v4.0 must be used for all new enrollments from 2 May and that enrolled subjects must be re-consented at their next visit. On 15 May the coordinator enrolled subject 015 using a v3.0 form because 'there were still 20 copies in the cabinet.' On 10 June, subject 012 (enrolled 20 April under v3.0) attended a scheduled visit but was not re-consented; the coordinator says this will happen 'at the end of the study.' Separately, subject 012's filed v3.0 consent is missing its second-to-last page, which contained the injury-compensation and HIPAA authorization language; the coordinator believes the subject 'was told verbally.' The CRA is on site 18 June.
669 words, about 3 min5The PI Is Leaving and the Storage Room Is Being Cleared
A single-site academic study of an investigational device-drug combination is closing after the last subject's final visit on 30 September. The PI moves to another institution on 15 January; the research office lease ends 31 December and the department wants the storage room cleared.
723 words, about 4 min