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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...

Electronic signature are currently accepted for any and all records, paper or electronic form. True or False? - False. The general provisions for electeonic signature criteria apply to records that are i. Created, modified, maintained, archived, retrieved, or transmitted, in electronic form ii. The criteria do not apply to paper records that are or have been transmitted by electronic means. If the electronic records meet the criteria specified in 21 CFR 11, thr agency will consider ...

Nuremberg Code (1947) - A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - 1. voluntary 2. necessary for results 3. logical design and results 4. avoid unnecessary harm 5. cannot result in death or disablement 6. risk assessment 7. protect subjects against harm 8. qualified investigators 9. right to withdrawal 10. right to end trial if nee...

Contract Research Organization - A 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? - False-they must sign both What is FDA form 3454 - Certification Financial Interests and Arrangements of Clinical Investigators What are the three main basic ethical principles of the B...

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 ...

CFR Title 21: Part 11 - Electronic Records; Electronic Signatures Part 11, Subpart A: General Provisions - -must be trustworthy, reliable, and generally equivalent to paper records -applies to electronic forms that are created, modified, maintained, archived, retrieved, or transmitted -where records meet requirements, it will be considered equivalent to full handwritten signatures, initials, etc. -must be available and subject to FDA inspection -may be in lieu of paper records or tr...

21 CFR Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11 Subpart B Electronic Records 21 CFR Part 11 Subpart C Electronic Signatures 21 CFR Part 50 Protection of Human Subjects 21 CFR Part 50 Subpart B Informed Consent of Human Subjects 21 CFR Part 50 Subpart D Additional Safeguards for Children in Clinical Investigations 21 CFR Part 56 Institutional Review Board 21 CFR Part 56 Subpart B Organization and Personnel 21 CFR Part 56 Subp...

April 30 1996 - ICH GCP Development Date Quality - ICH Q Efficacy - ICH E Safety - ICH S Multidisciplinary - ICH M guidance for industry, consolidated guideance - ICH E 6 Clinical Safety Data Management Definitions and Standards - ICH E2A Safety pharmacology studies for human pharmaceuticals - ICH S7A Electronic records, electronic signatures - 21 CFR Part 11 Informed Consent - 21 CFR Part 50 Financial Disclosures - 21 CFR Part 54 ...

Nuremburg Code - The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - 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 8. conducted by scientifically qualified 9. subjects can withdraw 10. r...

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 eff...

What influences a persons metabolic rate? - Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two - Fat Foods that raise insulin levels have... - added sugar When feeling stressed, you may feel relief after eating a piece of chocolate because... - it will raise dopamine levels What reduces the number of receptors for dopamine - insulin What percentage of Cardiac Rehab patients re overweight or obes...

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 21 C...

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...

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 LAR...

Biometrics - A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - An electronic signature based upon...

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 ...

When isn't an IND application needed? - IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) - FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human research/literature information -Additional information (drug dependence and abuse potential)...

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 LAR...

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