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ACRP-CPI exam Format | ACRP-CPI Course Contents | ACRP-CPI Course Outline | ACRP-CPI exam Syllabus | ACRP-CPI exam Objectives

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 trial 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)

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