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Exam Code: ACRP-CPI
Exam Name: ACRP Certified Principal Investigator
Number of Questions: 125 multiple-choice questions
Scoring: 100 questions are scored, while the remaining 25 are pre-test questions
Time: 3 Hours
Passing Marks: scaled score of 600 or higher

1.1 elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use)
- Review/Analyze background information (e.g., product development plan, IB)
- Identify the expected or unexpected results associated with investigational products
- Develop research question and/or hypothesis
- Identify the safety and expected therapeutic effects of the investigational product by verifying the preclinical and clinical research done so far (using the IB)
- Develop, update, and/or review the Investigators Brochure

1.2 elements of a protocol
- Develop the protocol (e.g., inclusion/exclusion criteria, procedures, schedule of events, safety and efficacy parameters)
- Implement plan of action for management of adverse event(s) [e.g., stop investigational product, retest, treat subject]
- Identify and/or explain study objective(s) and endpoints
- Identify and/or explain study design

1.3 rationale for complying with a protocol
- Evaluate protocol for scientific soundness (e.g., risks, benefits, validity of study procedures, endpoints)
- Evaluate protocol for feasibility (in terms of practicality of execution, not evaluation by site)
- Ensure compliance with study requirements and regulations
- Ensure consistency between the sites standard operating procedures (SOPs) and the study requirements

1.4 study objective(s) and end points/outcomes
- Identify and/or explain study objective(s) and endpoints
- Critically analyze study results
- Prepare clinical trial/study report

1.5 elements of and rationale for subject eligibility requirements
- Develop and/or follow a recruitment strategy
- Conduct prescreening activities with potential study subjects
- Screen trial subjects

1.6 statistical principles
- Critically analyze study results
- Identify and/or explain study design
- Prepare clinical trial/study report
- Develop and/or maintain randomization procedures of investigational product

1.7 study design characteristics (e.g., double-blind, crossover, randomized)
- Identify and/or explain study design
- Conduct unblinding procedures as applicable
- Evaluate study for feasibility (site determining ability to successfully conduct the study)
- Develop and/or maintain randomization procedures of investigational product
- Develop and/or Maintain unblinding procedures of investigational product

1.8 treatment assignments (e.g., randomization, open label, registries)
- Develop and/or maintain randomization procedures of investigational product
- Ensure clinical trial registry requirements are met
- Minimize potential risks to subject safety

1.9 supplemental/rescue/comparator product(s) in study design
- Assess subject safety during study participation
- Ensure and document follow-up medical care for study subjects, as applicable
- Assess, manage, and/or review subject laboratory values, test results, and alerts

2.1 protection of human subjects Develop and/or review informed consent form
- Comply with subject privacy regulations
- Ensure adequate consent and documentation
- Verify adequate implementation and documentation of the informed consent process
- Implement plan of action for management of adverse event(s) [e.g., stop investigational product, retest, treat subject]

2.2 vulnerable subject populations Identify and/or address potential ethical issues involved with study conduct
- Minimize potential risks to subject safety
- Develop and/or implement study education plan and/or tools for subjects
- Participate in and document the informed consent process(es)

2.3 subject safety issues Assess, manage, and/or review subject laboratory values, test results, and alerts
- Differentiate the types of adverse events that occur
- Assess AE causality
- Maintain follow-up to determine resolution of adverse event(s)
- Ensure timely review of safety data

2.4 confidentiality and privacy requirements
- Comply with subject privacy regulations
- Ensure compliance with study requirements and regulations
- Prepare the study site for audits and inspections

2.5 conflicts of interest in clinical research
- Comply with IRB/IEC requirements
- Identify the role and proper composition of IRB/IECs
- Ensure IRB/IEC review/written approval of study and study documents
- Ensure compliance with study requirements and regulations

2.6 elements of the IB Review/Analyze background information (e.g., product development plan, IB)
- Identify the expected or unexpected results associated with investigational products
- Develop research question and/or hypothesis
- Identify the safety and expected therapeutic effects of the investigational product by verifying the preclinical and clinical research done so far (using the IB)
- Develop, update, and/or review the Investigators Brochure

2.7 recruitment plan/strategies Develop and/or follow a recruitment strategy
- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval
- Ensure IRB/IEC review/written approval of study and study documents
- Re-evaluate the recruitment strategy as needed

2.8 elements of the informed consent form
- Develop and/or review informed consent form
- Ensure adequate consent and documentation
- Instruct subjects on proper use of investigational product
- Implement protocol amendments

2.9 informed consent process requirements
- Verify adequate implementation and documentation of the informed consent process
- Delegate study-related roles and responsibilities
- Escalate significant findings as appropriate
- Comply with IRB/IEC requirements

2.10 components of subject eligibility requirements
- Screen trial subjects
- Document reasons for subject discontinuation (i.e., causes, contact efforts)
- Ensure investigator/site protocol compliance
- Assess subject compliance

2.11 blinding/unblinding procedures Develop and/or Maintain unblinding procedures of investigational product
- Manage investigational product recall at the site and from study subjects
- Conduct unblinding procedures as applicable

2.12 safety monitoring Verify appropriate reporting and documentation of adverse event(s)
- Ensure timely review of safety data
- Assess subject safety during study participation
- Oversee the management of safety risks (e.g., clinical holds, product recalls)

2.13 adverse events classification, documentation and reporting
- Assess AE causality
- Maintain follow-up to determine resolution of adverse event(s)
- Verify appropriate reporting and documentation of adverse event(s)

2.14 subject discontinuation criteria/procedures
- Document reasons for subject discontinuation (i.e., causes, contact efforts)
- Ensure timely review of safety data
- Assess subject safety during study participation

2.15 subject retention strategies Develop and/or implement study education plan and/or tools for subjects
- Schedule subjects
- Conduct subject visits
- Develop trial management tools

2.16 protocol deviation/violation identification, documentation, and reporting processes
- Identify and report potential fraud and misconduct
- Investigate potential fraud and misconduct
- Develop or participate in protocol training

3.1 clinical development process (e.g., preclinical, clinical trial phases, device class)
- Develop and/or review the product development plan
- Develop research question and/or hypothesis
- Review/Analyze background information (e.g., product development plan, IB)
- Identify the safety and expected therapeutic effects of the investigational product by verifying the preclinical and clinical research done so far (using the IB)

3.2 IRB/IEC role, composition and purpose
- Comply with IRB/IEC requirements
- Identify the role and proper composition of IRB/IECs
- Coordinate protocol and/or protocol amendments through appropriate approval processes (e.g., IRB/IEC, sponsor, regulatory authority)

3.3 IRB/IEC reporting requirements
- Ensure IRB/IEC review/written approval of study and study documents
- Inform the sponsor and IRB/IEC of any deviations from the protocol and document as appropriate
- Prepare study summary and/or close-out letter for IRB/IEC

3.4 regulatory reporting requirements
- Inform study subjects of trial results, in accordance with regulatory requirements
- Inform the sponsor and IRB/IEC of any deviations from the protocol and document as appropriate
- Ensure compliance with study requirements and regulations
- Submit documents to regulatory authorities
- Prepare for and/or participate in audits and inspections
- Respond to or facilitate response to audit/inspection findings

3.5 protocol and protocol amendment submission and approval processes
- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval
- Ensure IRB/IEC review/written approval of study and study documents
- Submit documents to regulatory authorities
- Identify issues requiring protocol amendments
- Implement protocol amendments

3.6 safety reporting requirements
- Develop, update, and/or review the Investigators Brochure
- Submit documents to regulatory authorities
- Verify appropriate reporting and documentation of adverse event(s)

3.7 elements of fraud and misconduct
- Identify and report potential fraud and misconduct
- Investigate potential fraud and misconduct
- Select qualified investigational staff
- Verify that investigational staff is qualified

3.8 audit and inspection processes (preparation, participation, documentation, and follow-up)
- Prepare the study site for audits and inspections
- Prepare for and/or participate in audits and inspections
- Respond to or facilitate response to audit/inspection findings
- Ensure appropriate staff, facility, and equipment availability throughout the study

3.9 significant milestones in the evaluation of efficacy and safety (e.g., interim analysis result, DSMB review )
- Ensure timely review of safety data
- Assess subject safety during study participation
- Ensure timely review of study data

4.1 roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority, vendors, etc.)
- Delegate study-related roles and responsibilities
- Develop project management tools
- Obtain/verify vendor credentials (e.g., lab certification/licensure)
- Select qualified investigational staff

4.2 project feasibility considerations
- Schedule, coordinate, and/or participate in pre-study site visit
- Evaluate protocol for feasibility (in terms of practicality of execution, not evaluation by site)
- Evaluate study for feasibility (site determining ability to successfully conduct the study)
- Identify issues requiring protocol amendments
- Facilitate site budget/contract approval process

4.3 principal investigator responsibilities
- Verify that investigational staff is qualified
- Develop or participate in protocol training
- Prepare, conduct and/or participate in study initiation activities
- Plan, conduct and/or participate in training of the investigational staff

4.4 indemnification/insurance requirements
- Obtain/verify vendor credentials (e.g., lab certification/licensure)
- Facilitate site budget/contract approval process
- Evaluate and/or verify investigator indemnification/ insurance

4.5 delegation of duties
- Verify that investigational staff is qualified
- Delegate study-related roles and responsibilities
- Plan, conduct and/or participate in training of the investigational staff
- Ensure investigator/site protocol compliance
- Maintain study related logs (e.g., site signature log, screening log)
- Identify and/or maintain Essential Documents required for study conduct

4.6 staff training requirements
- Ensure appropriate staff, facility, and equipment availability throughout the study
- Select qualified investigational staff
- Delegate study-related roles and responsibilities

4.7 site initiation activities
- Verify Essential Documents required for study conduct
- Develop source document templates
- Develop and implement monitoring guidelines/plans
- Prepare, conduct and/or participate in study initiation activities
- Schedule, coordinate, and/or participate in pre-study site visit

4.8 staff oversight
- Prepare, conduct, and/or participate in interim monitoring visit(s)
- Perform onsite monitoring activities
- Create, document, and/or implement corrective and preventive action (CAPA) plans

4.9 principles of study monitoring (e.g., risk-based, full SDV, remote, etc.)
- Develop and implement monitoring guidelines/plans
- Prepare, conduct, and/or participate in interim monitoring visit(s)
- Perform onsite monitoring activities
- Document, communicate, and follow up on site visit findings

4.10 elements of an effective corrective and preventive action (CAPA) plan
- Document, communicate, and follow up on site visit findings
- Create, document, and/or implement corrective and preventive action (CAPA) plans
- Escalate significant findings as appropriate
- Identify issues and recommend investigator/site corrective actions

4.11 site close-out activities
- Prepare for and participate in close-out monitoring visit(s)
- Reconcile investigational product and related supplies
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)
- Manage study records retention and availability

5.1 roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority, vendors, etc.)
- Delegate study-related roles and responsibilities
- Develop project management tools
- Obtain/verify vendor credentials (e.g., lab certification/licensure)
- Select qualified investigational staff

5.2 elements of a study budget
- Facilitate site budget/contract approval process
- Develop trial management tools
- Evaluate study for feasibility (site determining ability to successfully conduct the study)

5.3 contract budget negotiations and approval process
- Facilitate site budget/contract approval process
- Evaluate and/or verify investigator indemnification/ insurance
- Coordinate protocol and/or protocol amendments through appropriate approval processes (e.g., IRB/IEC, sponsor, regulatory authority)

5.4 project and/or study timelines
- Manage study supplies (e.g., lab kits, case report forms)
- Ensure adequacy of investigational product and other supplies at site
- Monitor investigational product expiration and/or manage resupply
- Develop project management tools
- Develop trial management tools
- Schedule subjects

5.5 investigational product characteristics (e.g., mechanism of action, stability, etc.)
- Prepare investigational product for administration
- Dispense investigational product
- Reconcile investigational product and related supplies
- Maintain accountability of investigational product
- Monitor investigational product expiration and/or manage resupply

5.6 investigational product reference materials (e.g., Investigational Brochure, instructions for use, user manual)
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- Prepare investigational product for administration
- Dispense investigational product

5.7 investigational product storage
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies
- Ensure adequacy of investigational product and other supplies at site
- Monitor investigational product expiration and/or manage resupply
- Maintain accountability of investigational product

5.8 investigational product accountability and documentation requirements
- Reconcile investigational product and related supplies
- Maintain accountability of investigational product
- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies

5.9 equipment and supplies use and maintenance
- Obtain/verify vendor credentials (e.g., lab certification/licensure)
- Manage study supplies (e.g., lab kits, case report forms)
- Perform and/or verify equipment calibration and maintenance

5.10 sample collection, shipment, and storage requirements
- Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)
- Follow standards for handling hazardous goods (e.g., International Air Transport Association (IATA)
- Manage study supplies (e.g., lab kits, case report forms)

5.11 subject responsibilities for study participation
- Instruct subjects on proper use of investigational product
- Assess subject compliance
- Ensure adequate consent and documentation

5.12 subject visit activities
- Conduct prescreening activities with potential study subjects
- Assess subject compliance
- Conduct subject visits

5.13 subject compliance exam
- Assess subject compliance
- Reconcile investigational product and related supplies
- Ensure investigator/site protocol compliance

5.14 communication documentation requirements (e.g., telephone, email, etc.)
- Develop source document templates
- Document, communicate, and follow up on site visit findings
- Develop trial management tools

5.15 purpose of and process(es) for protocol compliance
- Ensure investigator/site protocol compliance
- Plan, conduct and/or participate in training of the investigational staff
- Develop trial management tools

5.16 corrective and preventive action (CAPA) process(es) and plan
- Create, document, and/or implement corrective and preventive action (CAPA) plans
- Escalate significant findings as appropriate
- Identify issues and recommend investigator/site corrective actions

5.17 investigational product shipment
- Maintain accountability of investigational product
- Manage investigational product recall at the site and from study subjects
- Monitor investigational product expiration and/or manage resupply
- Verify Essential Documents required for study conduct

6.1 essential documents for the conduct of a clinical trial (e.g., trial master file)
- Identify and/or maintain Essential Documents required for study conduct
- Verify Essential Documents required for study conduct
- Manage study records retention and availability

6.2 elements and purposes of data collection tools (e.g., eCRF, EDC)
- Review and approve completed eCRF/CRF
- Collect, record, and report accurate and verifiable data
- Transmit data to Data Management

6.3 source documentation requirements
- Develop source document templates
- Collect, record, and report accurate and verifiable data
- Perform query resolution

6.4 data privacy principles
- Ensure compliance with electronic data requirements (e.g., passwords and access)
- Ensure access to source data by authorized parties, and protect confidentiality by limiting unauthorized access
- Ensure consistency between the sites standard operating procedures (SOPs) and the study requirements
- Comply with subject privacy regulations

6.5 study documentation practices (accurate, complete, timely, legible, dated, and identify the trial)
- Collect, record, and report accurate and verifiable data
- Perform query resolution
- Manage study records retention and availability

6.6 source data review (SDR) and source data verification (SDV) purpose and process
- Perform query resolution
- Ensure access to source data by authorized parties, and protect confidentiality by limiting unauthorized access
- Perform onsite monitoring activities
- Document, communicate, and follow up on site visit findings

6.7 data management principles
- Develop trial management tools
- Collect, record, and report accurate and verifiable data
- Transmit data to Data Management
- Ensure timely review of study data
- Ensure compliance with electronic data requirements (e.g., passwords and access)

6.8 record retention and destruction practices and requirements
- Ensure access to source data by authorized parties, and protect confidentiality by limiting unauthorized access
- Manage study records retention and availability
- Ensure timely review of study data
- Maintain study related logs (e.g., site signature log, screening log)