CCRP Study guides, Class notes & Summaries

How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answers5 working days How many members must sit on an IRB? - correct answers5 How long must an IRB retain records per 21 CFR 56? - correct answers3 years after completion of research What are the criteria for IRB approval of research? (7) - correct answers1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Info...

CCRP EXAM WITH 185 QUESTIONS AND ANSWERS 2023

CCRP EXAM/275 QUESTIONS AND ANSWERS

Assessment - an objective evaluation or appraisal of an individual's health status, including acute and chronic conditions How does an assessment gather information? - through collection of data, observation, and physical examination What type of assessment? •Gather information about the patient from available sources such as medical records or reports from diagnostic studies • Perform direct measurements on the patient such as 12-lead EKG, blood pressure, or body mass index - obje...

How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed ...

Year/ description of the Nuremberg Code - 1947- German physicians conducted unethical experiments on concentration camp prisoners without their consent. What implications came of the Nuremberg Code? - Ten elements of human research including voluntary informed consent is absolutely essential. Year and description of the Declaration of Helsinki - 1964- Based on the principles of the Nuremberg code. This declaration laid out principles for PHYSICIANS to follow. First significant effort of th...

SAE - Serious Adverse Event: - results in death - is life threatening (patient was at risk of death at time of the event) - results in persistent or significant disability - congenital anomaly/birth defect Short Form - A document that states that the elements of informed consent have been presented orally to and understood by the participant or the participant's LAR. 4 components of short form - 1. A short form consent document 2. And oral presentation of the required elements of consen...

21 CFR 11 - Electronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - Protection of Human Subjects/Informed Consent B - Informed Consent 50.23 - Exception from General 50.24 - Exception from Informed Consent Requirements for Emergency Research 50.25 - Elements of Informed Consent 50.27 - Documentation of Informed Consent D - Additional Safeguards for Children 21 CFR 50 Subpart B - 50.25 Elements of Informed Consent