NIH IPPCR COMPLETE FINAL EXAM

NIH IPPCR COMPLETE FINAL EXAM 2023 -2024 What describes a properly designed Case Report Form (CRF) - ANSWER Collects relevant data in accordance with the protocol Allows for efficient data in accordance with the protocol Facilitates the pooling of data across studies **All of the above Scientific misconduct can cause which of the following? - ANSWER Make other scientists upset because they have spent time and resources to replicate manipulated data Damage to institutional reputations Undermine public perception of truthfulness of science Loss of government financial support Jail time All of the above In the proposed ethical framework for clinical research, the final principle "respect for enrolled subjects" is understood to include: - ANSWER Establishing a contract between the subject and the researcher ***Monitoring the subject's welfare and protecting confidentiality of information Keeping the financial costs of participation reasonable Informing the subject of new information only after the study is published What is a systematic and independent examination of trial-related activities and documents to determine whether the evaluation trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and the applicable regulatory requirements? - ANSWER Amendment Site initiation visit ***Audit Routine monitoring visit Differences in health outcomes among different demographic groups are the result of the complex interaction of several factors, including: - ANSWER A - cultural and racial/ethnic identity B- Socioeconomic and occupational trajectory C- Biology D- Healthcare E- Environment and geography F- All of the Above ***G - A, B, and E Which of the following statements about control groups or control arms in a study is FALSE? - ANSWER Control groups can take many different forms. The specific question being addressed in the study directs the choice of the control group or groups for the study. ***All good studies have a placebo arm. The most egregious ethical violation in the Public Health Services' Tuskegee syphilis study was that : - ANSWER The participants were injected with syphilis What is reliability - ANSWER ***The consistency in a measure The size of the operation definition If you are conducting clinical research that is funded by the NIH, you are always required to follow the Common Rule - ANSWER True The NIH Library of Medicine hosts the clinicaltrials.gov website, which is mandated by: - ANSWER ***FDA Journal policy for publication IND registration