Bioresearch - Samenvattingen, Aantekeningen en Examens

ACRP CP Exam Questions and Answers Quality documentation practices ALCOAC stands for - Answer-Attributable, Legible, Contemporaneous, Original, Accurate, Complete After the New Drug Application is approved, the responsibility for reporting safety issues to the FDA rests with - Answer-The sponsor To whom may a sponsor transfer its responsibility for any or all of its clinical trial obligations? - Answer-Contract Research Organization Define role of CDRH and abbreviation - Answer-Center...

PMLS Exam Questions and Answers 100% Solved Instrument S O M T - Entire process of S O M T A clinical lab cannot exist without these technologies Utilization of a computerized info system for data input retrieval and analysis - Automation and computer literacy is the mantra of the new gen. LIS Quality control, Assurance and performance improvement - Carried out using a srt of standard, control, pooled sera and performed daily, weekly, or monthly. It is established in every aspect of cli...

30-day hold - correct answer (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA approval to proceed with enrollment. Also, the time period between when a company submits an IND and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the proposed protocol. (see "Clinical Hold.") 120-day Safety Report - correct answer Amendme...

FDA Inspection Flashcard 100% Solved FDA Inspections: - ANSUnder the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the power to inspect clinical investigators, sponsors, contract research organization (CRO), institutional review board (IRB), and other parties involved in clinical trial conduct. This is done through the Bioresearch Monitoring (BIMO) program. The goal of the BIMO program are: - ANS1. To protect the rights, safety, and welfare of subjects involved ...

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 needed ...

ACRP CP SAMPLE QUESTIONS AND ANSWERS |latest updates| Which ICH Guideline is known as the GCP guideline? - ANSWER E6(R2) What are the basic ethical principles of the Belmont Report? - ANSWER Beneficence, Respect for persons, Justice Define CBER, and full title - ANSWER Center for Biologics Evaluation and Research FDA center that regulates blood, vaccine, gene therapy and tissue What is the International Conference on Harmonization (ICH) Guidelines? - ANSWER ...

What do clinical development group do? - correct answers Develop study protocols; manage and execute clinical plan and manage the budget. What does the Regulatory group do? - correct answers Navigate the regulatory landscape through development and approval. What does the Process development group do? - correct answers Optimize cell lines and manufacturing process. For biologics they consider genetic Stability, Ease of growing production cells, Yield in bioreactor, Yield of formulated p...

FDA Inspection Flashcard 100% Solved FDA Inspections: - ANSUnder the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the power to inspect clinical investigators, sponsors, contract research organization (CRO), institutional review board (IRB), and other parties involved in clinical trial conduct. This is done through the Bioresearch Monitoring (BIMO) program. The goal of the BIMO program are: - ANS1. To protect the rights, safety, and welfare of subjects involved ...

Duidelijke en overzichtelijke samenvatting voor het vak Genetica dat samen wordt getoetst met fermentatie en metabolisme. Het vak wordt gegeven in periode 12 van de minor Bioresearch op de opleiding Life Sciences & Chemistry aan de Hogeschool Inholland. Alle leerdoelen voor dit vak zijn in deze samenvatting verwerkt. Verder is de samenvatting gebaseerd op de hoorcolleges en de hoofdstukken 1, 2, 3, 4, 6, 12, 15, 17, 18 en 19 van het boek 'Introduction to Genetic Analysis'