Ccrp study guide exam Study guides, Class notes & Summaries

SOCRA CCRP Certification Final Exam Study Guide. Nuremburg Code - correct answer The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - correct answer 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities ...

SOCRA CCRP Certification Exam Study Guide 2024 Update.SOCRA CCRP Certification Exam Study Guide 2024 Update.

CCRP Final Exam Study Guide Practice Questions. Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - correct answer PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - correct answer The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - correct answer The subject inclusion and e...

SOCRA CCRP Certification Exam Study Guide 2024 Update..SOCRA CCRP Certification Exam Study Guide 2024 Update..

SOCRA CCRP Certification Exam Study Guide 2024 Update

CCRP SOCRA FINAL EXAM STUDY GUIDE. 21 CFR Part 11 - correct answer Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B - correct answer Electronic Records 21 CFR Part 11 Subpart C - correct answer Electronic Signatures 21 CFR Part 50 - correct answer Protection of Human Subjects 21 CFR Part 50 Subpart B - correct answer Informed Consent of Human Subjects 21 CFR Part 50 Subpart D - correct answer Additional Safeguards for Children in Clinical Investigations 21 CF...

5 The minimum number of IRB members Subjects cannot be enrolled until IRB/IEC approval has been obtained In a non-emergency situation, under which of the following conditions, if any, may subjects be enrolled into a study prior to IRB/IEC approval? The Sponsor The responsibility for ensuring that the investigator understands a clinical trial lies with: A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects...

How are lipids carried - on lipoproteins in the blood because they are insoluble in water How are lipids carried - on lipoproteins in the blood because they are insoluble in water Proteins found on lipoproteins - apolipoproteins Proteins found on lipoproteins - apolipoproteins Density of lipoprotein with less lipid and greater protein - more dense Density of lipoprotein with less lipid and greater protein - more dense Density of lipoprotein with more lipids and less protein - less dense D...

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 ...