ACRP CCRC Exam Prep (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A

ACRP CCRC Exam Prep (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A

ACRP CCRC Exam Prep (Latest 2024/ 2025
Update) Questions and Verified Answers|
100% Correct| Grade A
Q: In the RBDM process, what’s the next step after determining the end goal?
Answer:
Risk assessment.
Q: True or False? A CRC claims that you doin’t need to assess the impact of your risk
management efforts on an ongoing basis as long as the plan was executed properly.
Answer:
False
Q: How is the seriousness of a risk calculated?
Answer:
Likelihood of risk x consequences of risk.
Q: True or False? RBDM only applies to RBM strategies.
Answer:
False
Q: What are three activities that should be considered by sites in a risk-based monitoring
environment?

Answer:

• Implementing additional quality control measures
• Revising study contracts
• Updating internal SOPs
  Q: Differences ithat may be seen in a RBM study include?
  Answer:
  Monitors may conduct less frequent on-site visits.
  Q: True or False? RBM will have no impact on site.
  Answer:
  False
  Q: True or False? An example of a risk indicator would be an out of range laboratory value
  related to IC/EC on a subject that was just randomized.
  Answer:
  True
  Q: True or False? RBM embraces quality improvement processes?
  Answer:
  True
  Q: True or False? A key component of RBM is building quality into protocol design in order
  to enable more focused and efficient monitoring.

Answer:
True
Q: True or False? Risk-based SDV makes more efficient use of monitoring resources by
focusing on data that impacts patient safety and the integrity of the clinical trial data.
Answer:
True
Q: The clinical trials transformation initiative (CTTI) recommends focus on what?
Answer:
Quality by design.
Q: True or False? RBM focuses on study-specific parameter to determine an appropriate blend
of monitoring activities.
Answer:
True
Q: True or False? RBM is a FDA based concept that doesn’t have any accountability to
international studies.
Answer:
False
Q: What are three key areas of focus in RBM?
Answer:

• Patient safety
• Accurate representation of key data
• Protocol compliance
  Q: True or False? RBM deploys available monitoring resources without regard for a trials
  specific identified risks.
  Answer:
  False
  Q: What should be considered part of a proactive approach for a sponsor?
  Answer:
• Identification of risk and strategies for mitigation
• Feasibility process to identify qualified sites
• Training a management plan to ensure sites are equipped to work on study
  Q: What should be considered part of a proactive approach for a site?
  Answer:
• Ensure that the study population matches the site population
• Verification that adequate resources are available to conduct the trial
• Ensure protocol requirements are consistent with standard of care
  Q: What are three key elements included as part of SOP development?
  Answer:
• Develop a template
• Designate categories
• Determine a number system
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What are expected or possible consequences of over-estimation of recruitment potential? – The trial will overrun its projected timeline- The recruitment period will be prolonged and more sites may be needed- The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget
What should be the first consideration when conducting a clinical trial? Subject welfare
When is the investigator allowed to deviate from the protocol? When there is an immediate hazard to a patient.
If the investigator wanted to deviate from the protocol for an immediate hazard to a patient, according to ICH E6 guidelines who world they need to report the deviation and rationale to, if appropriate? – The Sponsor- IRB/IEC- Regulatory Authorities
Which conditions should be fulfilled when enrolling a subject into your trial? – Subject meets all inclusion criteria- Subject has given written informed consent
You’ve been delegated to handle the storage and inventory of IP. The study drug must be stored below 25C/77F. On a summer Monday morning you discover that the temperature recording machine in the storage room has failed so you doin’t know what the temperature has been over the weekend. You check the current temperature; it’s 24C/75F. What should you do? – Contact the Sponsor, explain what happened and ask for instructions- Set up a site staff meeting to conduct a root cause analysis
A protocol amendment was issued for a trial. Your site received IRB approval for the amendment and wants to implement the increase in PO dose for your trial subjects as identified in the amendment trial subjects. As delegated consenting duties you must re-consent trial subjects before being able to administer the adjusted dose. You decide to only re-consent trial subjects who are still taking the IP and not from the subjects woh already completed their drug intake period. Is this allowed according the E6 Guideline for GCP? No, these subjects are still enrolled in the trial and therefore need to be updated on any changes to the protocol.
A trial subject informs you she no longer wants to participant in the trial. What should your course of action be? You ask if the patient wishes to share the reason why she wants to leave the trial. If not, you exclude the subject from the trial immediately.
A patient cannot recall the name of the heart condition medication he took a few years ago. This is important information for deciding whether the patient may be enrolled in a clinical trial (IC/EC). What’s your best course of action? You attempt to retrieve the patients medical history by contacting previous caregivers and you wait for additional information before enrollment.
Who has ultimate trial responsibility for each subject? The principle investigator.
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB? No
What statements are true concerning an adverse drug reaction? – All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR- An ADR suggests a relationship to trail medication- All ADRs must be documented
What Adverse Events (AEs) are Serious Adverse Events (SAEs)? – Any AE that results in death- Any AE that results in inpatient hospitalization- Any AE that is a congenital anomaly
During a study visit a patient tells the investigator that she visited an emergency room and received intensive treatment for allergic bronchospasm. Since the patient was in the emergency room for only three hours, the investigator did not assess the event as serious. Is this a correct assessment? No, this would be a medically important event and should be considered serious
What data points minimally need to be reported by the site when reporting an SAE, so that the sponsor can process the event? Identification of event, product, and trial subject
During a visit with investigator, a subject reported feeling heart palpitations for a brief period of time during the previous evening. The heart palpitations resolved without reoccurrence. The investigator considered these symptoms to be unrelated to study drug. The next day, the subject told a fellow student that he felt tired and was planning on taking a nap. Later, the subject was found dead. A preliminary report from the medical examiner indicated the subject died of pulmonary embolism. What should your next course of action be? – Record these events in case report form- Immediately notify sponsor about serious adverse events
When asked by a regulatory body why they received SAE related information on 12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason being they received the trial related SAE information from the investigator in 12/2013. Is the sponsor correct in only holding the investigator accountable for their late reporting? No, the sponsor should support the conduct QC activities with the sites to help them ensure timely SAE reporting.
A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator considers this event possibly related to the study drug even though this is not listed in the IB as a potential adverse reaction. What would the investigator report this event to the sponsor as? An unexpected, serious adverse event
A 22y/o male was entered into a clinical study for treatment of schizophrenia The study drug was administered orally, BID. One week later, the subject visited the investigator complaining of sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug. How should this severe throat be classified? – An adverse event- An adverse drug reaction
In regards to AE and ADR reporting, what statements are true? – All ADRs are AEs but not all AEs are ADRs- Worsening in pre-existing medical conditions is an AE-Preplanned hospitalization is usually not an SAE
What determines the causality of an adverse event? The investigator
Which term best describes the cyclical process that involves the Plan, Do, Check, Act activities? Quality improvement
Which term best describes an independent assessment of completed work to ensure it will meet applicable quality standards? Quality assurance
Which term best describes the activities done to ensure quality output? Quality control
Which term requires structure and a definition of acceptable standards of performance? Quality planning
Which is represented in ALCOA-C? Attributable
What does CAPA stand for? Corrective and Preventive Action
When not completed correctly, which is a major contributing factor to an ineffective CAPA plan? Root cause analysis
What are the cyclical activities performed a part of quality improvement? Plan, Do, Check, Act
What is sued to determine root causes? – Fishbone diagram- Process flow charts- The 5 Whys
What are fishbone diagrams, process flow charts, and the 5 whys used for determining? Root causes
What is the key difference between quality improvement and quality assurance activities? Can be performed by persons involved in doing the work.
What are the elements of quality management system? – Quality planning- Quality assurance- Quality control
What is part of a quality management plan? – Quality policy statement- Quality goals- Organizational structure with defined roles
What documents support quality control? – SOPS, – Concomitant medication log
Quality standards are set by? – Regulatory bodies- IRB/IECs
What are the basic steps of risk management? – Analyze risk- Identify risk- Control risk
Adhering to the principles represented in ALCOA-C support? Good documentation practice.
What are the correct order of steps CAPA performs? – Identify issue- Determine root cause- Implement plan for correction- Assess effectiveness of correction
Having which two people sign and date the consent form is a quality standard for the informed consent documentation? The subject and the person obtaining consent.
True or False. Moving away from preventing problems to identifying and correcting problems is a key paradigm shift taking place in clinical trial conduct. False
True or False. When engaged in quality improvement activities, it’s important to identify who is to blame for quality failure? False
What skills are essential for making risk based decision making successful? – Quality control skills- Motivational skills- Change management skills
What are steps in risk assessment? – Identifying the consequences of risks occurring- Categorizing risks- Identifying risks
What risk should be appointed highest priority to manage in view of patient safety and data quality? Insufficient IP accountability.
When practicing RBDM in clinical research, what should be the primary focus? Subject safety and quality of the data.
When assessing the seriousness of a risk, what are the primary considerations that need to be taken into account? – The likelihood of occurrence- The consequences of the occurrence
When assessing the seriousness of a risk, what should the risk be compared to? Standard clinical practice.
What is essential to keep in mind when determining actions to mitigate potential risks? The make a risk-based decision following a risk management plan.
Where should potential risks be documented? A risk management plan.
What skills are most affected by the introduction of risk-based decision making? – Motivational skills- Change management
Whats the most important thing to keep in mind when introducing risk-based decision making into clinical research? The focus of clinical research is on patient safety and quality data.
At what time period during the trial is a risk management plan benefical? At all stages of the trial.
When should a risk management plan be updated? Continuously
Whats the first step in the RBDM process? Determining an end goal.
What are the objectives of RBDM in clinical trials? – Targeting quality control activities to the most vital pints to ensure quality data- Applying risk avoidance and risk mitigation strategies to avoid endangering subject safety
What are two true statements about RBDM? – Risk-based decision making is a process, not a one-time activity- RBDM is a continuous process in which the endpoint leads back to earlier stages
Planning for how to handle risks include what two activities? – Risk avoidance- Risk mitigation
What are two possible risk mitigation strategies? – Training staff- Implementing SOPs
What are the sites responsibilities regarding QC? – Sites need to ensure high quality of data- Sites need to conduct their own QC
In the RBDM process, what’s the next step after determining the end goal? Risk assessment.
True or False? A CRC claims that you doin’t need to assess the impact of your risk management efforts on an ongoing basis as long as the plan was executed properly. False
How is the seriousness of a risk calculated? Likelihood of risk x consequences of risk.
True or False? RBDM only applies to RBM strategies. False
What are three activities that should be considered by sites in a risk-based monitoring environment? – Implementing additional quality control measures- Revising study contracts- Updating internal SOPs
Differences ithat may be seen in a RBM study include? Monitors may conduct less frequent on-site visits.
True or False? RBM will have no impact on site. False
True or False? An example of a risk indicator would be an out of range laboratory value related to IC/EC on a subject that was just randomized. True
True or False? RBM embraces quality improvement processes? True
True or False? A key component of RBM is building quality into protocol design in order to enable more focused and efficient monitoring. True
True or False? Risk-based SDV makes more efficient use of monitoring resources by focusing on data that impacts patient safety and the integrity of the clinical trial data. True
The clinical trials transformation initiative (CTTI) recommends focus on what? Quality by design.
True or False? RBM focuses on study-specific parameter to determine an appropriate blend of monitoring activities. True
True or False? RBM is a FDA based concept that doesn’t have any accountability to international studies. False
What are three key areas of focus in RBM? – Patient safety- Accurate representation of key data- Protocol compliance
True or False? RBM deploys available monitoring resources without regard for a trials specific identified risks. False
What should be considered part of a proactive approach for a sponsor? – Identification of risk and strategies for mitigation- Feasibility process to identify qualified sites- Training a management plan to ensure sites are equipped to work on study
What should be considered part of a proactive approach for a site? – Ensure that the study population matches the site population- Verification that adequate resources are available to conduct the trial- Ensure protocol requirements are consistent with standard of care
What are three key elements included as part of SOP development? – Develop a template- Designate categories- Determine a number system
Whats an example of quality assurance at a site? Independent audits
What’s the purpose and preferred order of training? Understanding, ownership, and application.-
What three assumptions are included in the six knowles principles for adult learners? – Practical- Relevancy oriented- Goal oriented
True or False? A retroactive approach is the best approach to ensure subject safety. False
What’s the primary purpose of SOPs? – To ensure consistency through standardization- To prevent individuals from conducting procedures differently than their colleagues
As a foundation for quality control the individuals that implement and follow the systems much have which of the following characteristics? – Solid understanding of the processes in place- Rationale behind why each system is required- Rationale behind why each SOP is required
Protocol adherence is derived from what? Good training techniques
The concept of pouring the pieces out of the box, trying to put the objects together as quickly as possible, then rebuilding it later is an example of what type of approach? Retroactive approach
What are three techniques used for process improvement? – Correction and prevention implementation- Identify plans for process management- Conducting a RCA to identify cause of error(s)
What’s an example of controlling processes? Identifying a plan for ongoing management, identify key leaders, and required skills.
What are three applications of adult learning? – Problem based learning (PBL)- Clinical problem solving- Problems require different expertise
What is a tool to identify gap in performance? Conducting a RCA
True or False? In the US, device trials are to be conducted under CFR part 812. True
Which countries adhere to ICH GCP guideline to facilitate the mutual acceptance of clinical data? Japan, Canada, Switzerland, US, EU
What is a true statement regarding FDA guidance for industry investigator responsibilities? FDAs guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on the topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are sited.
What are expectations in relation to the qualifications of an investigator? – Be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial.- Be thoroughly familiar with appropriate use of IP- Permit for monitoring and auditing by the sponsor and inspection by the appropriate regulatory authorities
True or False? If the investigator is a non-physician, the investor should make adequate provision for an necessary medical care. True
What are three true statements with respect to protecting the rights, safety, and welfare of study subjects? – Providing subjects with method of communication with the investigator or qualified designee for questions or concerns- Adhering to the protocol so that study subjects aren’t exposed to unreasonable risk- Providing reasonable access to needed medical care
True or False? Protecting the rights, safety, and well-being of clinical trial subjects is the most important element of investigator responsibility. True
True or False? Within the US, clinical investigations of drugs and biological products must be conducted in accordance with 21 CFR part 312. True
What areas are applicable to assess the adequacy of supervision by an investigator? – Whether individuals who were delegated tasks were qualified to reform such tasks- Whether study staff received adequate training on how to conduct the delegated tasks- Whether there was adequate supervision and involvement in the ongoing conduct of the study
Which entities should be listed on form 1572? – PI- Facility where research is being conducted- IRB
When should 1572 be modified? – Staff change- Lab change
What documentation must accompany the 1572 submission? PI CV
The 1572 is an agreement between the PO and who? FDA
To whom is 1572 submitted? Sponsor/CRO
At what point during a clinical trial is a 1572 created and signed? Study start-up
Who must sign 1572? PI
How soon before the FDA, OMB expiration date, must the form 1572 be revised and submitted? This date doesn’t apply to the resubmission of form and should be ignored.
If there are co-investigators working on a clinical trial, where should they be listed on 1572? Submit separate 1572 for each investigator.
Who’s the least likely to be included in section 6 on 1572? On-site pharmacist who’s only dispensing IP.
What’s considered part of documentation of delgation? – Identification of dates of involvement in clinical trials- Proof of training received that qualifies individual to perform a delegated task- Description of the delegated tasks
What are the purposes of the 1572 form? -Identify facilities involved in conducting the clinical trial project- Commitment by investigator for appropriate conduct of the clinical trial- Name and address of where the investigation will be held
True and False? If a clinical trial required home visits, the subjects address should be listed on 1572. False
True or False? If a resident is on rotation, and assessed an AE, it’s okay if they’re NOT listed on 1572. True
True or False? The 1572 is considered a legally binding contract between the PI and FDA. False
Clinical trials assessing a medicinal products safety may fall which phases? Phase I, II, III, IV
In which trial phases would the following trial design most likely be found? An international double-blind randomized trial comparing the efficacy of two doses of trial drug with a commonly used competition in 50 sites recruitment of 10-30 subjects each. Phase III, IV
The drug ‘Enhance’ has been approved for marketing in wound healing in adults. When it’s on the market, the plan is to explore using it in children in the future. Which actions should be taken? – A development program for use in children should be written- Experience with use in children so far should be collected and used in the development plan- Conduct pharmacodynamic/pharmacokinetic studies in children if theres no relevant information available from similar compounds
What should be contained in study design? – Appropriate comparators- Adequate numbers of subjects- Clear endpoints
You’re a CRA looking for a site to conduct a phase II trial. What should you be looking for to ensure the site is able to conduct the trial successfully? – Sufficient resources to ensure patient safety- Sufficient resources (staff, materials, financial) to conduct the required interventions as per protocol- Ability to collect data on therapeutic efficacy, dosage, and other trial-specific goals
A site struggles with the conduct of a phase III trial due to lack of site staff to be able to conduct all visits and collect required data as identified in the protocol. Upon completion, the investigator tells the CRA and site staff during a follow-up meeting that she no longer wants to conduct trials because of the resource challenges they faced. What would you recommend the investigator do? Evaluate available resources (staff, time, patient population, financial) and conduct trials in phase for which the site has resources.
What’s the difference between phase III and IV trial? – Phase IV usually requires more subjects and data collection than Phase III- Phase III usually has fewer subjects and follow-up visits than Phase IV
True or False? An investigator claims he can conduct the Phase II trial without issues as he’s already conducted ten Phase III and IV trials. False
WhWhich type of trial will most likely be used in a Phase I? Dose-response trial
Concept that refers to sensitivity of overall conclusions to various limitations of data, assumptions, analytic approaches and data analysis. Robustness
What is true about confirmation vs exploratory trials? Confirmatory trials are intended to provide firm evidence in support claims.
What value type has components that may sometimes be analyzed separately? Composite
What variable type is usually a scale of ordered categorial ratings? Global assessment
What variable type may not be a true predictor of the clinical outcome of interest? Surrogate
What design is most commonly used for confirmatory trials? Parallel group
What are three true statements about cross-over trials? – The subjects are their won control- The drug being studied is highly variable- Some subjects start on treatment arm A and other on treatment arm B or C
What are the main reasons for having multicenter trials? – Timeframe for recruitment- Possibility of generalization of results
True or False? Concluding that theres a difference between two treatments when in actual fact there is no different is type 1 error. True
True or False? Concluding there’s no difference between two treatments when in actual there’s a difference is type II error. True
When doing a trial with purpose to generate data to get marketing approval for generic product by comparing it to original product, which type of trial would be the type to choose? Equivalence
Which statement about equivalence margin is NOT true?a) The equivalence margin should be specified in protocolb) The equivalence margin is the largest difference that can be judged as being clinically acceptablec) Equivalence is inferred when entire confidence interval falls within equivalence margind) Equivalence margin should be same as difference observed in superiority trials of active comparator d) Equivalence margin should be same as difference observed in superiority trials of active comparator
What techniques reduce bias? – Blinding – Randomization
Which is NOT true about Double Dummy trials?a) Double Dummy may be single-blind or double-blindb) Double Dummy is a placebo-controlled trialc) Double Dummy enables blinding for products that have different physical appearanced) Double Dummy enables blinding for products which have different administration schedule b) Double Dummy is a placebo-controlled trial
Which results of trial conduct issues have statistical impact? – Changes to IC/EC- Trialing accural rates- Sample size adjustments
According to ICH E9, IDMCs should provide what? – Intervals assess the safety of clinical trial- Recommend to sponsor whether to continue, modify, or stop trial
Which are for full-analysis sample set? – Includes all randomized subjects- Complete follow-up of all randomized subjects for study outcomes if necessary- Most likely to mirror normal day to day practice
Which are for a per-protocol sample set? – Completion of pre-specified minimal exposure to treatment is necessary- Availability of measurements of primary variable is necessary- No major protocol violations nor violation of entry criteria
Investigator continues to randomize patient until patient is grouped with investigators desired product. Is this ethical? No
Data manager suspects fraud and immediately calls investigator stating fraud was committed. Was this the best course of action? No
What must or may the physician do with regard to unproven intervention? (Declaration of Helsinki) May consider an unproved intervention
Who can detect fraud/misconduct? Site staff, trial subject, auditors/inspectors, CRA, data entry personnel or data manager, whistle blower, writer of final trial report
Investigator continues postponing dates for QC. Is this unethical behavior? Yes
When selecting trial site, which does the selector need to be vigilant about regarding ethics? Investigator and site staff have potential subjects and resources to conduct trial according to protocol
What are three key principles of the Belmont Report? – Respect for persons- Justice- Beneficence
True or False? Nuremberg Code states human subjects should be at liberty to withdraw. True
True or False? A site has limited resources and the investigator is promised a trip if enrollment increases. The CRA claims this is ethical. False
True or False? There’s no need to review/cross-check because unethical conduct almost never occurs anymore. False
Inspection objective include verifying? – Rights, safety, welfare of subjects- Compliance with regulations- Adherence to pharmacovigilance requirements- Data integrity of submitted data and reports
A report prepared by marketing-authorization holder describing the worldwide safety experience with medicine at defined time after authorization is called? Periodic Safety Update Report (PSUR)
Potential reasons for an unannounced clinical investigator inspection can include what? – Receipt of complaint- On termination of clinical site- In response to sponsor or IRB/IEC inspections
What type of risk-based inspection involves the selection of a number of clinical trials for the inspection sample? Routine National Systems Inspections
True or False? Globalization of clinical research is a major factor that’s led to development of a common and accepted framework and sharing of inspection observations in different regions. True
The FRD CDER published information about inspection site selection tools that takes into account what three levels of risk attributes? Application level, study level, clinical site level
Factors that influence GCP inspection selection process include? – The number of UK patients and nature of subjects- Outcome of previous GCP inspections- Organization with no inspection history
True or False? Concerns about accuracy of submitted data can include an unusual recruitment pattern. True
True or False? For the EMA, inspections are conducted by the EMA inspectorate of the EU. False
True or False? Comprehensive data management plans can help ensure the recording of accurate and complete data. True
True or False? Regulatory investigators must have rights/privileges granted for electronic record systems. True
Current coordinator is asked a question about the enrollment source completed by prior coordinator during regulatory inspection. What should her response be if she knows the correct answer? Decline answer as she has no first hand knowledge of the creation of source document
Documents that may be inspected to show the sponsors oversight of trial may include: – Documents that describe transfer of obligations- Investigator/site qualifications/selection process and training- Monitoring plans, reports and corrective actions through the monitoring process
Important immediate inspection preparation strategies include: – Inform personnel- Secure facility resources- Organize study related documents- Ensure access to original data
Directed/for-cause inspections may focus on? The particular reason that prompted the inspection
What is the major focus area for routine inspections for a clinical investigator? – Data reviews- ICF process and documentation
What is the major focus area for a sponsor/CRO GCP inspection related to trial? – Vendor selection and management- Data management (e.g. review of data management plan)
Common inspection management strategies include? – Scope of inspection- Understand inspection timeframes-Copy of personnel records
What does NAI stand for? No action indicated
What does VAI stands for? Voluntary action indicated
What does OAI stand for? Official action indicated
According the MHRA, an inspection finding is considered critical where evidence exists that signifiant and unjustified departure from applicable legislative requirements has occurred with evidence that: – Safety/well-being of subject jeopardized- Clinical trial data are unreliable- Systematic quality assurance failure
EMA uses how many categories to rate inspection findings for inspectors? 3
Responses to a regulatory authority must? Come from the person most responsible and in the timeframe specified.
For each electronic system to be acceptable for use in research the system must? – Be available and accessible- Be valid- Have back-up and internal parameters
The purpose of password protection is the limit access to the information entered electronically, and also allow for __. Which can be reviewed at any time to see who entered, altered or reviewed information at any time. Audit trail
What is the definition of a case report forms? A printed, optical, or electronic document designed to record information to be reported to the sponsor on each trail subject.
What’s the definition of source data? All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.
Examples of electronic systems utilized in clinal trials? – electronic medical records- electronic case report forms (eCRFs)- electronic diaries
A number of attributes are considered of universal importance to source data and the records that hold those data. These include that data records are? – Accurate and legible-Contemporaneous and original- Attributable and consistent
Password protection allows monitors and auditors to confirm that subjects confidentiality was maintained as well as providing a methodology to confirm that only individuals with appropriate education, experience and training completed study related procedures as tasked on a what? Delegation log
General regulatory expections for electronic systems include: – Password control- Audit trail- Appropriate access by qualified personnel (read vs write access)
Electronic systems are being used in collaboration by sponsors and sites to: – Reduce transcription errors- Increase accessibility to data in faster timeframe- Allow for rapid review of results and safety management
Capturing source data electronically and transmitting it to the electronic case report form should? – Eliminate unnecessary duplication of data and reduce the possibility for transcription errors- Eliminate transcription of source data prior to entry into an electronic CRF- Promote real time access for data review and facilitate remote monitoring of data
When allowing clinical research associates to review electronic medical records systems which should be allowed: – Provide a user password- Generate an audit trail of records accessed- Allows ‘read’ access only
Which group publication includes a set of 12 user requirements for source data, regardless of media or technology used to hold the data? CDISC
What key ares should be included for consideration in development by sponsor or investor? – Creation and modification of systems from sponsor or investigator- Creation, modification and transfer for data from sponsor or investigator- Control, copying and storage
Examples of electronic signature? Signature linked to password
When a site utilizes electronic medical or health records, the purpose and significance include? – Collection of patient data on site- Allows review of ‘charts’ by all physician who have access- Allows for legibility
eCRFs when used as source should enhance? – Remote review by sponsor- Timing of completion of data entry- Faster data review and cleaning (queries)
True or False? The investigator should NOT attempt to negotiate clinical trial budget with sponsor. False
In an industry initiated clinical trial, the budget should contain three independent sections which comprise the overall study budget. – Start-up costs- Per-subject costs- Variable costs
True or False? In an industry initiated clinical trial, the site should ask sponsor for an advance vs start-up costs. False
What’s the most critical document for site to read and understand before attempting to draft a budget? Protocol
True or False? Indirect cost should only be charged on per-subject costs. False
This budget section should include all necessary site cost before study is ready to enroll it’s first subject and be non-refundable. How are these costs defined. Start-up costs
True or False? The charge to sponsor should be the actual cost of protocol required items or services. False
The following is incorporated into clinical trial agreement and defines when site will be paid for study performance. Payment terms
True or False? The site should review sponsors budget before drafting own site budget. False
During the budget preparation phase, the site should? – Analyze protocol- Determine study services- Obtain necessary clarifications from sponsor- Analyze CRF
True or False? Protocol amendments are from changes to protocol. The site does NOT need to evaluate the budget to determine if a budget amendment is required. False
This budget section should include all services that may or may NOT occur during course of study (sponsor to be invoiced if they occur) Variable costs
True of False? The per subject cost section of budget should include cost for one single completed subject. True
The following are examples of what type of costs? Examples: drug dispensing fees, sample preparation, supply costs, copies of diagnostic test, subject stipends, shipping costs, subject injury monitoring, space utilization, and training. Hidden costs
True or False? Sites should prepare internal budget that’s detailed and includes actual costs. Internal budget should be provided by sponsor. False
A study protocol provides? A plan for a scientific experiment or for medical treatment.
Protocol design starts with? Identifying gab in knowledge.
Consideration not found in protocol is? Funding
Activity present in research (scientific) is? Exploratory data collection, analysis, and hypothesis testing.
Hypothesis testing involves? Determination if possible relationship among variable is indeed true.
Study protocol is composed of? – Background- Purpose- Methods
Hypothesis can be used for assessing opening a study at a site in which way? Hypothesis can judge scientific merit and site interest in study.
How many categorizes are in research design? Four
Population, case-control, and cohort studies are what type of study? Observational
How do population studies differ from case-control? Larger in sample size.
Randomized Controlled Trials (RCTs) differ from other study types in what way? – Greatest level of interaction with participant- Greatest involvement with investigator- Most complex design and structure
In terms of risk? All studies carry some degree, even if minimal.
Risk related to study can involve what aspect? – Risk of study participants- Risk of study integrity
Why is statistics considered risk in study design and feasibility assessment? Statistics used to ensure adequate same size for avoiding unnecessary risk.
Other considerations for study design and feasibility assessment? – Ethics- Funding- Practicality
Funding for study? Derived from external or internal sources.
Adaptive study design is defined as? Clinical trials capable of changes in design/feature in response to accumulated data.
Translational research study design defined as? Predominately takes a bench to bedside approach.
Patient Centered Outcomes Research study design defined as? Takes into account voice and input for patients.
Comparative effectivness study design defined as? Research intended to inform healthcare by assessing existing treatments.
Research study design can be utilized in what function? – Constructing new protocol- Amending existing study- Study feasibility assessment
Investigator continues randomizing patient until they received investigators desire product. Is this ethical? No
Data manager calls investigator saying fraud has been committed. Did the data manager act as they should? No
According to Declaration of Helsinki, where a proven intervention does NOT exist, the physician…? May consider an unproven intervention.
Who can detect fraud or misconduct? Site staff, trial subjects, auditors/inspectors, monitors (CRA), conducting QC, data entry personnel or data manger, whistle blower, writer of final trial report
Investigator continues postponing meeting because he’s busy. Do you consider this unethical behavior? Yes
When selecting trial sit for trial, which does the selector need to be vigilant about in regards to ethics? Investigator and site staff have potential subjects and resources needed to conduct that according to protocol.
What are three key principles of Belmont Report? – Respect for Persons- Justice- Beneficience
True or False? Subjects have right to withdraw from experimental trial? True
True or False? Bribes trip to NY for increased number of enrolled patients. Is this ethical? False
True or False? Unethical conduct almost never occurs so investigator doesn’t need to cross-check data. False
Critical elements of patient center care include? – Informed decision making occurs when communication and education needs are met- Assessments of comprehension are performed- Support is provided respective to individual values and needs
What are characteristics of health literacy? – Obtain, process, understand basic health information- Relies on cultural and conceptual knowledge
Decisional conflict can be experienced when? Patient has uncertainty about which course of action to take.
As clinical researchers we can be culturally competent by? Understanding and acknowledging the difference between various cultures.
What percentage of subjects who sign consent can later recall important elements? 50%
What tip for enhancing understanding during consent process is true? – Explaining 2-3 concepts at a time- Giving opportunity for participant to recall information- Using visual images
Which FDA regulation states that selection of subjects be equitable? 21 CRF 56 III (a) (3)
Which are ways to personally improve in administering informed consent to potential subjects? – Analyze own communication skills; seek improvement- Ensure patients interested have information knowledge, behavior needs meet- Examine SOPs on consent
Acceptable method used to assess subject comprehension of consent form and study? Teach-back method
What should be considered for all patients during ICF process? – Emotional state- Learning style- Health literacy
A person with LEP? Limited ability to read, write, and/or speak english.
What guideline did FDA provide during 2014 in connection with LEP when conducting clinical research in USA? Individual with LEP should not be excluded from research.
To reduce issues related to LEP, researchers should? – Use consent forms translated to patients native language- Use qualified interpreter
What are clinical trial performance metrics? Data points that provide insights into operational performance.
What’s an effective approach used for recruitment, accural, retention? Raising awareness of trials in community as a whole will lead to increased referrals and trail inquiry.
What’s an example of a site attribute indicative of operational performance? Promotes trails awareness programs.
How often should essential rates indicative of RAR be measured? At least twice per year.
What’s a benefit of assessing detailed metrics regarding screen failures? The ability to observe trends across trial types, or within trial itself.
Wh’s the industry average patient conversion ratio? For every 1 subject randomized, what’s the average number of subjects that need to be identified? 10
What’s a reason why clinical sites should measure accural rates? To identify strengths and opportunity for development and improvement.
What does the following statement mean? Appropriateness of trials should be >75%. The ratio of the number of eligible trial subjects beginning treatment is >75% for previous month.
What’s considered critical to a quality trial program? Normalization of trails at both institutional and community levels.
What are two examples of how normalizing of trials can be achieved? – Education programs for staff/providers/general public- Communication programs about active trials at trial sites
Which are considered essential measures for clinical trials RAR? Rates of overall and particular population accural, rates of clinical trial refusal rates, rates of clinical trial participant retention.
What’s a benefit of measuring time between final contract signature and enrolling firm subject? This cycle time is indicative of overall success in achieving accural goal for trial.
“What makes a metric “”meaningful””?” It leads to testable hypotheses and predictions.
Which study phase has the lowest retention rate? Phase III
Why is it recommended to measure accural rates often? Diagnose problems, access effect of improvement efforts, motivate staff.
True or False? The menu/portfolio of studies offered at a site, along with research staff feasibility assessment prior to selecting a trial has an important impact on accural. True
“What are questions related to “”capacity”” within feasibility assessment?” – Will our study coordinator workload allow for adequate management of new trial?- Will PI have time and interest to oversee new trial per regulations?- Can various site departments/staff provide testing and procedures as outlined in protocol without additional training/new processes put into place?- Will sponsor require travel to an investigator meeting for protocol training and will site staff be able and willing to attend?
Why is it important to collect data from ongoing trial at a site on regular basis? Help a site with future trial selection.
True or False? It’s important for sites to have formal trial/patient feasibility assessment processes which involve internal stakeholders in order to create balanced portfolio/trial menu. True
True or False? Sponsors doin’t need to consider how well a particular site believes they can accure subjects to a study prior to selecting a site to participate in trial. False
True or False? Studies of research sites globally have shown that between 2009 and 2013, 95% achieved their enrollment goals. False
What are potential reasons that a site may not reach their accural goal that could be avoided by conducting a feasibility assessment? – Lack of interest/buy-in by site physicians and staff- Poor organizational structure at sponsor level- Few patients presenting at site with diagnosis
What are benchmarks that can predict likelihood of successful accrual? – Expected enrollment time period- Time to first enrollment
True or False? Trial accural performance involves collecting data in real time for all ongoing studies as well as past studies at a participating site. True
Menu diversification means? A sites trial menu should be in concordance with types of trials offered, patients seen, and burden of disease on community.
“Core issues related to “”accruability”” are?” – Level of burden on participant- Potential coverage issues with third party payers- Exclusions and how they may impact certain groups of patients common within community
Name an element of a feasibility assessment related to analyzing clinical and ethical characteristics of protocol design and perceived impact of study objectives on local patients treatment. Interest
True or False? Researchers have found that trials failing to reach 60% minimum projected accrual goal within expected period will always reach enrollment goals by time of enrollment closure. False
What are elements of a formal feasibility assessment process? – Interest- Accruability- Capacity- Menu diversification
True or False? One of four participants leave a trial before it’s completed. True
True or False? Only ~50% of participant who signed consent could explain how they’re randomized during the trial. True
True or False? Clinical research sites may recruit subjects for trials by contacting their own patients, asking outside physicians to refer their patients, or by advertising trial within community. True
True or False? It’s important for a clinical research site to have a clinical trial menu reflective of patient population. A formal feasibility assessment of all potential trials often satisfies this need. Assessment includes examining interest, capacity, potential rate of accrual and diversification True
True or False? Sponsors expect sites to be prepared with estimate of number of subjects they believe they can enroll within specific time frames, including justification for the amount. This estimate is used by sponsors to determine which sites to invite to participate in their trials. True
True or False? A well-educated person is always health literate. False
True or False? Typically, when a participant signs consent, it indicates they clearly understand the information within the consent and details of trial. False
True or False? In the US, it’s ethically unacceptable to routinely consider non-english speaking patients ineligible for trial. True
True or False? It’s important for research sites to have a plan in place (including qualified translators) for consent patients with LEP. True
TWhich are operational principles for effective and efficient recruitment and retention? – Support: All enrolled participants receive adequate support to ensure compliance and retention throughout trial.- Normalization: Trials are normalized by all staff/providers on an institutional-wide basis through effective communication with patients- Trial selection: Trials selected for local implementation will appropriately meet need of local participants.
Which groups have the lowest participation rates? – People above 65 years old- People from rural areas- People from racial/ethnic minority groups
Sponsors consider what criteria when selecting clinical research sites for their trials – Coordinator workload (number of studies per coordinator)- IRB/IEC timelines and reporting policies- Number/type of competing trials ongoing at site- Investigator expertise in area being researched
Which elements of patient centered care as described? – Learning style- Health literacy- Emotions
Which are characteristics of health literacy? – Capacity to process and understand basic healthcare information- Rely on cultural/conceptual knowledge
What’s the take home point? Patient approach and offer: A clinical site makes a decision that each patient who’s potentially eligible for trial be offered a chance to participant. Reducing opportunities for subjective assessment.
What’s the take home point? Optimal communication and education: All participants will have their information, knowledge, and behavior-related needs met. Fostering dialogue and assessing comprehension.
The average population in the US of person with EP is estimated to be? ~9%
In summary, the 7 operational principles are? The legs on which all of our efforts to improve accrual are based.