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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...

Laws passed by national legislative bodies; establish authority of national regulatory body Regulations Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance "current thinking" of regulatory bodies; non-binding ...

What is an orphan drug program? FDA program that provides development of drugs for rare diseases Nuremburg Code set of standards proclaimed following the trial of Nazi doctors in 1947 Kefauver-Harris Amendment Amendment to Food Drug and Cosmetic Act that requires informed consent ...

Which of the following is a disclosure of financial interests form? FDA Form 3455 Which of the following is a certification of financial interest form? FDA Form 3454 If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: FDA Fo...

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....

45 CFR 46 Subpart A "Basic HHS Policy for Protection of Human Research Subjects": (46.100) Requirements for 1) assuring compliance by research institutions, 2) researchers' obtaining and documenting informed consent, 3) Institutional Review Board (IRB) membership, function, operations, review o...

Electronic Records, Electronic Signatures CFR Title 21: Part 11 Informed Consent CFR Title 21: Part 50 Financial Disclosure CFR Title 21: Part 54 Instiutional Review Board CFR Title 21: Part 56 Investigational new Drug Application CFR Title 21: 312 New Drug Ap...

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...

Which of the following is a disclosure of financial interests form? ... Which of the following is a certification of financial interest form? ... If the investigator did have financial arrangement with the sponsor, he/she would submit the following form: ... This form is subm...

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 00:18 01:18 How long must an IRB retain records per 21 CFR 56? 3 years after completion of research What are the criteria for IRB ...

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...