Guías de estudio, Notas de estudios & Resúmenes

CCRP SOCRA Exam Graded A+ Contract Research Organization - ANSA person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - ANSFalse-they must sign both What is FDA form 3454 - ANSCertification Financial Interests and Arrangements of Clinical Investigators What are the three main basic eth...

CCRP SOCRA Exam Graded A+ FDA Part 11 - ANSelectronic signatures are of the same validity as handwritten signatures, must provide 2 identifiers and verify identification of signer FDA Part 50 - ANSFood and Drugs, and ICF FDA Part 56 - ANSIRBs FDA Part 312 - ANSinvestigational new drug application FDA Part 812 - ANSinvestigational drug exemption FDA Form 482 - ANSNotice of inspection FDA Form 483 - ANSLetter of investigational observations/citation of noncompliance that specifies how lon...

CCRP EXAM WITH VERIFIED QUESTIONS AND ANSWERS How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANS5 working days How many members must sit on an IRB? - ANS5 How long must an IRB retain records per 21 CFR 56? - ANS3 years after completion of research What are the criteria for IRB approval of research? (7) - ANS1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informe...

CCRP Exam Graded A+ How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANS5 working days How many members must sit on an IRB? - ANS5 How long must an IRB retain records per 21 CFR 56? - ANS3 years after completion of research What are the criteria for IRB approval of research? (7) - ANS1. 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 fr...

CCRP Exam Graded A+ 21 CFR 11 - ANSElectronic Records; Electronic Signatures B - Electronic Records C - Electronic Signatures 21 CFR 50 - ANSProtection 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 - ANS50.25 Elements of Informed Cons...

CCRP Definitions Test 100% Solved 21 CFR 50 - ANSProtection of Human Subjects Sponsor - ANSa person who initiates a clinical investigation, but who does not actually conduct the investigation Sponsor-investigator - ANSan individual who both initiates and actually conducts (alone or with others) a clinical investigation Human subject - ANSan individual who is or becomes a participant in research, either as a recipient of the test article or as a control Institution - ANSany public or priv...

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 ...

Who was tried in the Nuremburg Military Tribunals and why? - Doctors who committed war crimes against humanity including medical experiments on concentration camp inmates and other human subjects without consent What was the outcome of the Nuremburg Military Tribunals? - After 140 days of proceedings with testimony of 85 witnesses and submission of 1,500 documents, American judges convicted 16 doctors on 8/20/1947. Seven were sentenced to death and executed 6/2/1948. What historical docume...

Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - The subject inclusion and exclusion criteria During a multi-site clinical study, whose responsibility is it to report subj...