Then it ind - Study guides, Class notes & Summaries

QASP-S Exam Study Guide Questions With Correct Answers Latest 2024/2025 | Graded A+. Positive Behavior Support - Answer an approach used to support behavior change. The method is not designed to "fix" the person & never uses punishment. Main idea: teaching someone a more effective/ acceptable bx will decrease problem bx. Who is a bx support plan for? - Answer indv who display challenging bx to the extent that it severely impacts their life. -can be developed and used at any age. PBS in a...

CITI Training 134 Questions With Complete Solutions Latest Updated 2024 (GRADED A+) What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this doc...

choosing a team is willing to commit to teams goals. You need someone who is a team player. If they are in it for personal fame and glory. see the big picture. a basic management skill is to think conceptually and not get bogged down int too many small details a good team member is willing to ask tough questions ever heard of the yes man" a good team member is willing to try something new. if something is restant to change they will be restant to thinking outsid ethe box or not able to gene...

CITI Training 134 Questions With Complete Solutions Latest Update Score A+. What must you file before conducting human clinical trials with an experimental drug? Correct Answer: IND application (Form FDA 1571) During the clinical development phase of the IND process, what must sponsors do? Correct Answer: Maintain current IND application by amending IND with new Form FDA 1571 and providing FDA with: safety updates copies of new protocols FDA 1572 Annual Progress reports this document n...

CITI Training Exam Review Questions With Complete Solutions Latest Update (Graded A+). What is the timeline of drug development? Correct Answer: Preclinical trials, IND Submission, Clinical Development (Phase I-III), NDA submission, Marketing (Phase IV) When does a sponsor submit the IND? Correct Answer: Prior to clinical development phases (human trials). *30 day process. What is the NDA? Correct Answer: New Drug Application, submitted prior to Phase IV marketing phase. How long does th...

CFA Level 1 - 101 Must Knows 368 Questions with Verified Answers Addition Rule of Probability - CORRECT ANSWER ADDITION: P(A or B) = P(A) + P(B) - P(AB) Roy's Safety First Criterion - CORRECT ANSWER Safety First Ratio = (E(R) - Rₜ) / σ Larger ratio is better If (Rₜ) is risk free rate, then it becomes Sharpe Ratio Sharpe Ratio - CORRECT ANSWER Sharpe Ratio = (E(R) - RFR) / σ Larger ratio is better If (Rt) is higher than RFR, then it becomes Safety First Ratio Centra...

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 ...

Cognitive Development Theory - Piaget is best known for this theory. Piaget believed that human development/behavior were the product of certain consistent and reliable patterns of interaction with the environment called Schemas Schemas - are goal oriented strategies that ind. use to explore the environment and learn more about the world. all ind. are born with schemas through which they perceive the environment. Adaptation - A reciprocal exchange between an individual and his environment. ...

three stages of drug development - correct answer -preclinical testing ... lab tests then two different species of animals.. (investigational new drug application (IND) to begin clinical research) -clinical research...on humans... then (new drug application (NDA) to get approval from FDA) -post marketing surveillance three phases of clinical trials before FDA approves - correct answer -phase 1: s...

QASP-S Exam Study Guide – Questions With Correct Answers Latest 2024/2025 | Graded. Positive Behavior Support - Answer an approach used to support behavior change. The method is not designed to "fix" the person & never uses punishment. Main idea: teaching someone a more effective/ acceptable bx will decrease problem bx. Who is a bx support plan for? - Answer indv who display challenging bx to the extent that it severely impacts their life. -can be developed and used at any age. PBS in ...