ACRP-CPI Exam Information and Guideline
ACRP Certified Principal Investigator - 2025
Below are complete topics detail with latest syllabus and course outline, that will help you good knowledge about exam objectives and topics that you have to prepare. These contents are covered in questions and answers pool of exam.
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 assessment
- 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)