SOCRA CCRP Certification Exam Questions with 100% Correct Solutions| Graded A+

Nuremburg Code - The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified 7. proper preparations and adequate facilities 8. conducted by scientifically qualified 9. subjects can withdraw 10. research must end the study if there is probable cause that continuing would lead to injury, disability, or death. Timeline of Historical Events - Nuremberg Code first (1947). Declaration of Helsinki second (1964). Belmont Report third (1979). Belmont Report Principles and Application - There are 3: 1. Respect for persons = informed consent 2. Beneficence = risk/benefit analysis 3. Justice = appropriate selection of patients Language Level Recommended for Informed Consent - 6th-8th grade 8 Basic Elements of informed Consent - 1. statement explaining the study involves research. 2. description of risks or discomforts. 3. description of benefits. 4. alternative treatments/procedures. 5. confidentiality. 6. compensation for involvement and/or injury. 7. who to contact. 8. voluntary and can discontinue Additional Elements of Informed Consent - 1. unforeseeable risks to subject. 2. participation can be terminated by investigator. 3. any additional costs. 4. consequences of the subject's decision to withdraw 5. significant new findings will be shared 6. approx # of subjects in the study. Differences between short and long informed consent form - Long = the standard consent form. Short = document states that the elements have been presented orally to and understood by the subject or LAR. ICF Monitoring Considerations - 1. subject has signed most recent IRB approved version 2. subject signature is present in addition to subject name 3. subject date themself and date is correct 4. any errors corrected w/single line thru error 5. all pages of ICF are present SAE Reporting Requirements for Investigator and Sponsor - 1. Investigator immediately reports to Sponsor 2. Sponsor reports to FDA and all investigators participating no later than 15 calendar days if it qualifies as reportable. What is a reportable SAE to the FDA? - 1. Serious and unexpected 2. findings from other studies suggest significant risk 3. Findings from animal or in-vitro testing 4. increased rate of occurrence of SAEs 5. unanticipated adverse device effect (UADE) What is a UADE? - Unanticipated adverse device effect (UADE) - any serious adverse effect on health or safety, any life-threatening problem or death caused by, associated with the device,.. not previously identified in nature, severity, or degree of incidence in the applications; or any others if related to rights, safety, or wefare of subjects UADE Reporting Requirements for Investigator and Sponsors - 1. Investigator submits to Sponsor and IRB asap, but no later than 10 business days after knowledge of event occurring. 2. Sponsor reports to all other IRBs and investigators, and FDA within 10 working days SAE reporting requirement for drug trial - 1. Immediately for the investigator 2. 15 calendar days for the Sponsor UADE reporting requirement for device trials - Within 10 working/business days for both investigator and Sponsor Consent and Assent Requirements for research involving children - 1. Parental consent from one or both parents or LAR is required 2. Child assent may be required as determined by the overseeing IRB. The period in which financial disclosure is needed - Disclosure is necessary during the course of the study and also one year after completion. What is the primary goal of the IRB? - To protect the rights and safety of human subjects. Minimum requirement of IRB members on a committee - = 5 members minimum. Requirements for a Significant Risk Study - 1. Follow all IDE regulations 2. Have IDE application approved by FDA prior to study start Requirements for a non-significant risk study (NSR) - 1. Follow abbreviated requirements according to 21 CRF 812.2 (b) 2. Do not need IDE application approved by FDA 3. Sponsors and IRB do not have to report to FDA prior to study start What is the definition of "minimal risk" research? - Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. When can IRBs use EXPEDITED review process? - 1. Some or all of the research involves no more than minimal risk 2. Minor changes in previously approved research during the approval period (of 1 year or less) What is a significant risk device? (SR) - 1. implantable and presents potential for serious risk 2. supports or sustains human life 3. substantial importance in diagnosing, curing, mitigating, or treating disease 4. otherwise presents a potential for serious risk What is a non-significant risk device? (NSR) - an investigational device that "does not meeting the significant risk requirement - NSR device study does NOT mean a "minimal risk" study. What is the required time frame of IRB record retention? - 3 years following study completion Pertaining to study design, what are the two most common tools used for reducing bias? - Blinding and randomization What is a DSMP? Data Safety Monitoring Plan? - A plan that is used to ensure the safety of the subjects. If required, a DSMP section should be included in the clinical trial protocol. What is a DSMB (Data Safety Monitoring Board?) - A group of experts that reviews research data to ensure subject safety and data validity following the plan described in the DSMP. DSMB is also commonly called the DMC. DSMB if required should have a section included within the protocol. What are ICH GCP recommendations for Adverse Events section in a protocol? - 1. The specification of safety parameters 2. methods and timing of the assessment - relationship to study drug/device and severity 3. Type and duration of the follow-up of subjects are their adverse events What should be in protocol statistics section according to ICH GCP guideline? - 1. statistical methods 2. number of subjects 3. level of significance 4. criteria for the termination of the study 5. procedure for accounting for missing, unused and spurious data 6. procedures for reporting deviations from the original plan 7. selection of subjects to be included in the analyses