ACRP-CP Exam 100% Verified Correct!!

Crossover - ANSWER when each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Parallel - ANSWER when subjects are randomized to 1 of 2 or more arms, each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses, and one or more control treatments, such as placebo and/or an active comparator A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study design they will use to test the efficacy of the IP? - ANSWER Non-Inferiority What type of clinical trial most likely requires enrollment of the largest number of research subjects? - ANSWER Therapeutic confirmatory (aka Pivotal Trial, Ph III, or Comparative Efficacy) Minimum number of membors on an IRB/IEC - ANSWER 5 .. lay people and medical professionals can be part of the IRB/IEC Who is responsible for providing the protocol - ANSWER The Sponsor The purpose of the SIV is to - ANSWER -review standard procedures -review the protocol -review the blank eCRFs Minimum SAE reporting requirements - ANSWER - Subject details (ID not name) - IP - Interventions for the event that is being reported - Details of the event - Details on the reporter of the event - Admin and sponsor or company details/ Vulnerable subjects - ANSWER - Junior members of the medical profession - Employees of a pharmaceutical company - Military personnel - Pregnant Women - Prisoners IRB/IEC Evaluates - ANSWER - The rights, safety, and well-being of the subjects participating in the trial - The subject selection procedure - The scientific tenability of the trial Serious Adverse Event (SAE) - ANSWER - results in death, is life threatening, requires inpatient admission, prolonged admission, congenital anomaly, or persistent incapacity -death itself is not neccessarily an sae - Seriousness does not equal severity in that Serious requires reporting while severe may not.. Severe may just be used to describe an AE - Must be reported by sponsor to authorities within 15 calendars days from sponsors first knowledge of the event Adverse Drug Reaction (ADR) - ANSWER - All noxious and unintended response that is related to any dose - If the reaction is possibly, probably, or definitely related to the drug, it is considered an ADR - All ADRs must be documented - ADRs are not always AEs Unexpected Event - ANSWER Not observed before. Or the Event occurred more often than previously observed Adverse Event (AE) - ANSWER - Any untoward medical occurrence that does not necessarily have a causal relationship with treatment. - Can be mild moderate or severe - Worsening of a pre-existing medical condition is an AE Non-Clinical Study - ANSWER - Not conducted on human subjects. -Provide preliminary safety and pharmacokinetic data needed to support studies in human Data Safety and Monitoring Board (DSMB) - ANSWER - Assesses the progress of a clinical trial, the safety data, and the critical efficacy endpoints - Can recommend that sponsors modify, end, or continue a trial. But cannot recommend they start a new trial WMA - ANSWER World Medical Association Declaration of Helsinki - ANSWER -Created by WMA in 1964 - Defines the ethical principles for medical research involving human subjects i.e.: 1. Importance of ICF Requirement of ethical review and approval of research before it is undertaken 2. Acknowledgement and guidance of special protections for vulnerable subjects 3. Recommends trials are registered on public database LAR - ANSWER Legally Acceptable Representative. (regarding consenting procedures) International Conference on Harmonization (ICH) - ANSWER Mission is to provide a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials Expected AEs - ANSWER Those that are consistent with the product information and were present on previous and preclinical trials Contents of the site TMF - ANSWER - IP accountability records - Subject sc