Capa review 1 - Study guides, Class notes & Summaries

CAPA REVIEW #1

SOCRA CCRP Exam (2023/2024) Rated A Timeline of Historical Events Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report respect for persons, beneficence, justice Application of Respect for Persons informed consent (autonomy, choose for themselves) Application of Beneficence risk/benefit analysis Application of Justice appropriate selection of patients (equality) Language Level ICF 6th-8th grade 8 basic elements of ICF 1. purpose, ...

CAPA REVIEW 1 Questions and Answers with Solutions 2024/2025

A company is performing routine site monitoring of its pivotal clinical study for a blood sugar meter and finds one site has not consented one-third of its subjects properly . What is the FIRST thing the company needs to do? A.Stop the entire study B. Inform FDA and ask for guidance C. Re-train the study staff, including the principle investigator D. Re-consent all improperly consented subjects - correct answer D Re-consent all improperly cons...

CAPA REVIEW #1.

Timeline of Historical Events - Nuremberg Code 1947, Declaration of Helsinki 1964, Belmont Report 1979 The Three Principles of the Belmont Report - respect for persons, beneficence, justice Application of Respect for Persons - informed consent (autonomy, choose for themselves) Application of Beneficence - risk/benefit analysis Application of Justice - appropriate selection of patients (equality) Language Level ICF - 6th-8th grade 8 basic elements of ICF - 1...

CAPA REVIEW 1.

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 elemen...

CAPA Exam: Domain 2 Processing Functions - Sections 1 & 2. Questions and answers. 100% Accurate. VERIFIED. Summary Statements - -Do not process for payment Use for reconciling purposes only Invoices Include - -Vendor name, address, and phone number Remittance information Invoice number Invoice date Standard terms & conditions, including payment terms PO reference (if applicable) Name of purchaser Description Unit and extended cost Sales Tax, Freight, and Tax Exempt status (if a...