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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)

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