ACRP Certified Professional ACRP-CP Question # 7 Topic 1 Discussion
ACRP-CP Exam Topic 1 Question 7 Discussion:
Question #: 7
Topic #: 1
A PI is reviewing the CRF for a recent subject visit and notices the participant's heart rate and temperature are not recorded. Which of the following study documentation practices was neglected?
The missing data indicates a lack of completeness in the study documentation. Completeness is a fundamental requirement in clinical trials, as all necessary information must be recorded accurately and in full. Missing vital signs such as heart rate and temperature can compromise the validity of the data and affect the study’s outcomes.
GCP guidelines state that all data collected during the study must be complete, accurate, and consistent with source documents.
"Clinical trial documentation must be complete, containing all data as required by the protocol toensure data integrity."
Objectives:
Ensure comprehensive data recording.
Maintain accuracy and completeness in study records.
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