ACRP CCRC EXAM QUESTIONS WITH COMPLETE SOLUTIONS LATEST UPDATED 2024 (GRADED A+)

ACRP CCRC EXAM QUESTIONS WITH COMPLETE SOLUTIONS LATEST UPDATED 2024 (GRADED A+) Audit - Answer Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Answer Confirmation audit took place Audit Report - Answer Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Answer Documentation of audit events Single Blind Study - Answer Subjects Unaware Double Blind Study - Answer Subjects & Researchers are unaware Comparator - Answer Item used as an active control references in a clinical trail Coordinating Committee - Answer Group a sponsor comprises to coordinate multicenter trials Coordinating Investigator - Answer An investigator who oversees multiple sites of a clinical trial (multicenter) IDMC - Answer Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or stop IEC - Answer Independent Ethics Committee; group who oversees protection, rights, safety & well-being of human subjects Investigator's Brochure - Answer Compilation of data on an investigational product used in human subjects Legally acceptable representative - Answer person whom is lawfully able to consent on behalf of another SAE - Answer Serious Adverse Event - Results in death, is life-threatening, requires long-term hospitalization, results in long term disability/hospitalization incapacitation or is a congenital birth defect Source data - Answer original clinical information from source documents (medical record information) Vulnerable subjects - Answer *Hierarchical structure employees *armed forces *detainees *incurable disease pts *homeless *poor *those in nursing home *minors *those unable to give consent ICH - Answer International Conference on Harmonization Principles of ICH & GCP - Answer *Protect research subjects *conduct research as it has been approved *research should be clear, organized & approved by an IRB/IEC IRB / IEC Responsibilities - Answer *Oversee principles of ICH/GCP *Make sure the PI / Co-Is are qualified * Review studies at least once a year Requirements of an IRB - Answer * at least 5 members * one non-scientific member * one non-institute member What needs reported to the IRB? - Answer *Changes / deviations from protocol due to unforeseen hazard * changes to subject risk * adverse events * new info that may impact subject safety Payment to subjects must be.... - Answer prorated & not contingent on subject completing study Investigator Responsibilities - Answer *Maintain delegation long *Ensure staff are trained/informed about the protocol (give delegated tasks) * Ascertain reason study participant withdraws consent while respecting their privacy & rights * Adhere to approved protocol *Document & explain any deviations from approved protocol * Process protocol amendments according to GCP *Manage proper storage & care for trial devices/drugs. (PI can delegate this task to trained professional - PharmD, etc) Protocol amendments should be submitted to - Answer 1. IRB 2. Sponsor 3. Regulatory Authority Changes in risk to subjects... - Answer should be included & approved on an updated ICF - patients enrolled should be re-consented Consenting illiterate subjects - Answer is okay, but must have impartial witness present Necessary aspects of ICF - Answer *Trial involves research *Trial purposes *Treatments - randomization aspect if applicable * Procedures *Subject responsibilities *Experimental Aspects of trial *Risks *Benefits *Alternatives to participating *Compensation * Compensation for trial related outcomes *Voluntary nature of trial *Who has access to direct records *Confidentiality of research records *New information will be made available to subject *Who to Contact *Involuntary termination *Trial Duration *Subjects to be enrolled Non-therapeutic trials can be conducted with consent from legal rep IF - Answer *trial objectives cannot be met by personal subject consent *low risk *trial is not prohibited by law *IRB has approved such inclusion How long must documents be retained per GCP? - Answer At least 2 years after last approved marketing application (organizations/sponsors, etc usually set a longer required period of 5-7 years) When to submit SAE to sponsor? - Answer Immediately (usually within 24 hours) Sponsors role - Answer *Complete & ensure SOPs are followed *seeks agreements from all parties *may use CRO to oversee; however, the sponsor is ultimately responsible CRO - Answer Contract Research Organization Sponsor/Investigator agreement should contain - Answer 1. Agreement to comply w/ GCP (adhere to protocol & IRB) 2. Agree to comply with data recording 3. Agree to permit monitoring 4. Agree to retain documents for specified length of time *Agreement should be signed by both parties Purpose of Trial monitoring - Answer *Ensure rights & safety of subjects are protected ACRP CCRC EXAM 2023 WITH COMPLETE SOLUTIONS. *Report on accuracy of trial data *Ensure trial is compliant (protocol, GCP, etc) How is a monitor selected? - Answer *Appointed by sponsor *Adequately trained & qualified *familiar with protocol, ICF, etc Responsibilities of monitor - Answer *Main line of communication b/w investigator & sponsor *Verify investigator qualifications *Verify product *Verify product storage *Verify dosing & who is receiving it *Subjects receive direction on product use *Products are accounted for appropriately *Verify protocol is being followed *verify written consent on each subject *ensure investigator has investigator brochure *ensure all staff are informed about the trial *verify only eligible subjects are being enrolled *report recruitment rate *verify source documents (CRFs match) *patient withdrawal or missed visits are reported on CRFs *notify PI of any missing data or signed edits to data *monitor reporting of AEs *report on deviations Auditors vs Monitors vs inspectors - Answer *Monitors - address data, storage of drug, & report to sponsor/investigator. They can be internal *Auditors - focused on compliance which is separate from routine monitoring - they should not be part of trial; independent committee reviewing data *Inspectors - IRB or regulatory body reviewing data Audit Plans - Answer differ based upon study design, complexity, number of subjects on trial, etc Required essential documents provided before study opens - Answer *IB *signed protocol & amendments *CRFS *ICF *ads to promote study *financial aspects of study *agreements (signed) *Approved by IRB study materials *Composition of IRB *Signed CVs of PIs *Storing & Handling of device/drug *shipping information ACRP CCRC EXAM 2023 WITH COMPLETE SOLUTIONS. *Emergency decoding procedures for blinded study *Master randomization list * Pre-trial monitoring report Required essential documents provided during study - Answer *updates to IB *updates to protocol / CRF, etc *approvals from IRB of updated materials *updates to any procedures / tests / shipping *records of any monitoring visits *signed ICF *completed CRFs, signed & dated *documentation of edited CRFs *source docs for completing CRFs *documentation of AEs/SAEs *subjects screening log *Subject enrollment log *subject ID code list * investigational product accountability