ACRP-CP Exam questions and answers 2023 update(verified for accuracy)

Crossover when each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment comparisons Parallel 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? Non-Inferiority What type of clinical trial most likely requires enrollment of the largest number of research subjects? Therapeutic confirmatory (aka Pivotal Trial, Ph III, or Comparative Efficacy) Minimum number of membors on an IRB/IEC 5 .. lay people and medical professionals can be part of the IRB/IEC Who is responsible for providing the protocol The Sponsor The purpose of the SIV is to -review standard procedures -review the protocol -review the blank eCRFs Minimum SAE reporting requirements - 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 - Junior members of the medical profession - Employees of a pharmaceutical company - Military personnel - Pregnant Women - Prisoners IRB/IEC Evaluates - 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) - 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) - 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 Not observed before. Or the Event occurred more often than previously observed Adverse Event (AE) - 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 - Not conducted on human subjects. -Provide preliminary safety and pharmacokinetic data needed to support studies in human Data Safety and Monitoring Board (DSMB) - 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 World Medical Association Declaration of Helsinki -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 Legally Acceptable Representative. (regarding consenting procedures) International Conference on Harmonization (ICH) Mission is to provide a unified standard for Europe, US, and Japan to facilitate the acceptance of clinical trials Expected AEs Those that are consistent with the product information and were present on previous and preclinical trials Contents of the site TMF - IP accountability records - Subject screening log - Signed ICFs Per ICH, how long must an IRB/IEC keep correspondence for after the completion of a clinical trial at least 3 years The signature page is an optional section of the IB (T/F) True Incapacitated subjects can provide consent as soon as capacity is regained (T/F) True Who should send Annual Progress Reports to the IRB/IEC The Investigator The investigator is required to share names of subjects with the IRB/IEC (T/F) False CRAs(monitors) cannot review source documents of subjects who have withdrawn consent. Even if the source document predates their consent withdrawal(T/F) True When should research studies involving human subjects be registered in a publicly accessible database before recruiting the first subject Any changes to safety language in an IB should be submitted to the IRB/IEC (T/F) True All SAE's must be life-threatening to be considered an SAE opposed to AE (T/F) True After completion of a study, where should the final trial close-out monitoring report prepared by the CRAbe filed in the Sponsor's files During a multi-site clinical study, Whose responsibility is it to report subject recruitment rate CRA (Monitor) What is the investigator's first priority when a subject wishes to withdraw prematurely from the trial to obtain the subject's reason for withdrawal CRC's can't adjust IP dose, even if they are a qualified physician (T/F) False. If a CRC is a qualified physician they can adjust IP dose Following unblinding in the case of a suspected serious unexpected adverse drug reaction, the treatment assigned to the subject turns out to be the comparator product. Who should the sponsor inform? The manufacturer of the product and/or the regulatory authorities If there is a a serious unexpected adverse drug reaction in a blinded trial, when should the investigator unblind the subject? The investigator unblinds before reporting the SUADR, in order to determine a safe treatment If a subject experiences a heart attack or other unexpected SAE that wasn't documented in the IB, Who must the event be immediately reported to? The sponsor and the IRB/IEC The study protocol does not need to include statistical analysis methods (T/F) False Subjects can be enrolled using lab results predating when the ICF was signed (T/F) True What must be done, at the site level, if the protocol is altered during the trial the subjects must be reconsented and the irb/iec should be informed and approve the changes if the trial is to continue If a person is in a life threatening situation that necessitates the test article, and they/their LAR cannot provide consent... what must the PI do to properly enroll the subj per required measures described in the protocol Receive documented approval/favorable opinion by the IRB/IEC prior to enrollment. Then ensure the subjs LAR is informed asap to continue the consent Pre-Trial Meetings Discuss: -subject availability -competing studies -lab requirements -sponsor expectations DSMB (Data and Safety Monitoring Board) -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 Incapacitated subjects can provide consent as soon as capacity is regained (T/F) True The signature page is a required section of the IB False All trial phases assess safety (T/F) True Phase I -Focuses on safety and dose in healthy subjects -Determine metabolic and pharmacologic action of the drug in humans -Investigates human pharmacology -The most typical study -Initial administration or IND into humans Phase II -Focuses on efficacy and side effects in subjects of that specific indication -A study which seeks to determine the ideal dose and regimen of a new IP to treat the indicated condition Phase III -Compares new tx to existing tx for that indication -a study which seeks to evaluate the IP to similar treatment options or placebo if there are no current tx's for the indication -determines therapeutic benefit and is done in a larger, specific population. Can be reffered to as a therapeutic confirmatory trial, pivotol trial, or comparative efficacy trial -Phase III trials usually have fewer subjects than Phase IV trials Phase IV -Therapeutic use, begins after drug approval -Tx is approved and available, but still evaluating for long term effects -Phase IV trials usually require more subjects and data collection than phase III trials Post Market -Analysis conducted after drug approval aka Phase IV -Provides the most significant amount of safety and efficacy in pediatrics trials with ltd. Number of participants Pediatric Trials -can be prepared for by developing a program for use in children - experience with use in children so far should be included in the development plan -conduct pharmacodynamic/pharmacokinetic studies in children if there is no relevant information available from similar compounds Study design must include: -clear endpoints -Appropriate comparators -Adequate # of subjects All SAE's must be life-threatening to be considered an SAE opposed to AE (T/F) True Any changes to an IB are not required to be submitted to the IRB/IEC (T/F) False. changes to safety language must be submitted to the IRB