CCRP case studies
CCRP · Put your knowledge to work in context.
The Certified Clinical Research Professional (CCRP®) credential is awarded by the Society of Clinical Research Associates (SOCRA), which states that it established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Individuals so recognized may use the "Certified Clinical Research Professional" or "CCRP®" designation. The CCRP case studies are 5 cases and about 4,008 words.
1The Post-Encounter Consent Signature
A research coordinator at a community clinic enrolls a 58-year-old participant into a Phase II hypertension trial. The participant speaks conversational English but reads at roughly a third-grade level.
759 words, about 4 min2The Eligible Patient Who Does Not Want the Randomization
A 71-year-old woman with treatment-resistant depression is referred to a randomized, double-blind trial comparing an investigational augmentation agent to placebo, added to her existing antidepressant. She meets all eligibility criteria.
784 words, about 4 min3The Unreported Deviation and the Site's Pattern
A CRC at a multi-site oncology trial reviews a monitoring report and finds that across the last 14 enrolled participants, 6 had at least one cycle of study drug administered outside the protocol-specified window (cycle length 21 days ± 2; actual intervals ranged 17–30 days). The deviations were never logged in the site's deviation tracker, and none were reported to the sponsor or IRB.
793 words, about 4 min4The Vulnerable Population and the Incentive
A study of a new anticoagulant seeks to enroll older adults (65+) recently discharged after hip-fracture surgery. The site proposes recruiting from a skilled nursing facility (SNF) where many residents have mild cognitive impairment and where the facility's medical director is a co-investigator.
791 words, about 4 min5The Unblinded Coordinator
A CRC on a double-blind, placebo-controlled trial of an anti-inflammatory for chronic pain is responsible for scheduling, drug accountability, and entering participant-reported pain scores into the EDC system. During a drug accountability check, she opens a sealed randomization envelope to reconcile a discrepancy in kit numbers and learns that participant 014 is on placebo.
881 words, about 4 min