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- elements of a protocol

- Identify and/or explain study objective(s) and endpoints

- Conduct prescreening activities with potential study subjects

- Screen trial subjects

- elements of an Investigational Brochure (IB) and/or investigational device use (instructions for use, user manual)

- Identify and/or explain study design

- Identify and/or explain study objective(s) and endpoints

- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB

- elements of and rationale for subject eligibility requirements

- Identify and/or explain study objective(s) and endpoints

- Conduct prescreening activities with potential study subjects

- Screen trial subjects

- rationale for complying with a protocol

- Identify and/or explain study objective(s) and endpoints

- Ensure compliance with study requirements and regulations

- Follow a study plan

- management plan

- monitoring plan

- statistical principles

- Identify and/or explain study design

- Maintain randomization procedures of investigational product

- Collect, record, and report accurate and verifiable data

- study design characteristics

- double-blind

- crossover

- randomized

- Identify and/or explain study design

- Maintain unblinding procedures of investigational product

- Evaluate study for feasibility (site determining ability to successfully conduct the study)

- study objective(s) and end points/outcomes

- Identify and/or explain study design

- Identify and/or explain study objective(s) and endpoints

- Ensure and document follow-up medical care for study subjects, as applicable

- use of supplemental/rescue/comparator product in study design

- Identify and/or explain study design

- Implement plan of action for management of adverse event(s)

- stop investigational product

- retest

- treat subject

- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies

- treatment assignments

- randomization

- open label

- registries

- Identify and/or explain study design

- Maintain randomization procedures of investigational product

- Instruct subjects on proper use of investigational product

- adverse events classification, documentation and reporting

- Maintain follow-up to determine resolution of adverse event(s)

- Ensure appropriate reporting and documentation of adverse event(s)

- Differentiate the types of adverse events that occur

- blinding procedures

- Maintain unblinding procedures of investigational product

- Conduct unblinding procedures as applicable

- Dispense investigational product

- components of subject

- Identify and/or explain study design

- eligibility requirements

- Conduct prescreening activities with potential study subjects

- Screen trial subjects

- confidentiality and privacy requirements

- Comply with subject privacy regulations

- 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

- elements of the IB

- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB

- Review the Investigators Brochure

- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval

- elements of the informed consent form

- Develop and/or review informed consent form

- Ensure IRB/IEC review/written approval of study and study documents

- Identify and/or maintain Essential Documents required for study conduct

- informed consent process requirements (e.g. paper, eConsent, assent)

- Participate in and document the informed consent process(es)

- Ensure adequate consent and documentation of the informed consent process

- Comply with IRB/IEC requirements

- protection of human subjects

- Assess subject safety during study participation

- Verify that investigational staff is qualified

- Minimize potential risks to subject safety

- protocol deviation/violation identification, documentation, and reporting processes

- Ensure investigator/site protocol compliance

- Assess, manage, and/or review subject laboratory values, test results, and alerts

- Inform the sponsor and IRB/IEC of any deviations from the protocol and document as appropriate

- recruitment plan/strategies (e.g. social media, digital, print, etc)

- Document reasons for subject discontinuation

- causes

- contact efforts

- Follow a study plan

- management plan

- monitoring plan

- Re-evaluate the recruitment strategy as needed

- safety monitoring

- Implement plan of action for management of adverse event(s)

- stop investigational product

- retest

- treat subject

- Oversee the management of safety risks at the site

- clinical holds

- product recalls

- Create, document, and/or implement corrective and preventive action (CAPA) plans

- subject discontinuation criteria/procedures

- Document reasons for subject discontinuation (i.e., causes, contact efforts) Comply with IRB/IEC requirements

- Implement plan of action for management of adverse event(s)

- stop investigational product

- retest

- treat subject

- subject retention strategies

- Develop and/or implement study education plan and/or tools for subjects

- Re-evaluate the recruitment strategy as needed

- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval

- subject safety issues

- Oversee the management of safety risks at the site

- clinical holds

- product recalls

- Minimize potential risks to subject safety

- Escalate significant findings as appropriate

- vulnerable subject populations

- Identify and/or address potential ethical issues involved with study conduct

- Ensure adequate consent and documentation of the informed consent process

- Participate in and document the informed consent process(es)

- conflicts of interest in clinical research

- Identify and/or address potential ethical issues involved with study conduct

- Identify and report potential fraud and misconduct

- Identify the role and proper composition of IRB/IECs

- audit and inspection processes (preparation, participation, documentation, and follow-up)

- Submit documents to regulatory authorities

- Prepare for and/or participate in audits and inspections

- Respond to or facilitate response to audit/inspection findings

- clinical development process (e.g., preclinical, clinical trial phases, device class)

- Submit documents to regulatory authorities

- Evaluate study for feasibility (site determining ability to successfully conduct the study)

- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval

- clinical trial registries and requirements

- Comply with IRB/IEC requirements

- Inform study subjects of trial results, in accordance with regulatory requirements

- Ensure consistency between the sites standard operating procedures (SOPs) and the study requirements

- elements of fraud and misconduct

- Identify and report potential fraud and misconduct

- Identify the role and proper composition of IRB/IECs

- Identify and/or address potential ethical issues involved with study conduct

- IRB/IEC reporting requirements

- Prepare study summary and/or close-out letter for IRB/IEC

- Ensure compliance with study requirements and regulations

- Comply with IRB/IEC requirements

- IRB/IEC role, composition and purpose

- Identify the role and proper composition of IRB/IECs

- Comply with IRB/IEC requirements

- Coordinate protocol and/or protocol amendments through appropriate approval processes

- IRB/IEC

- sponsor

- regulatory authority

- protocol and protocol amendment submission and approval processes

- Coordinate protocol and/or protocol amendments through appropriate approval processes

- IRB/IEC

- sponsor

- regulatory authority

- Implement protocol amendments

- Ensure IRB/IEC review/written approval of study and study documents

- regulatory reporting requirements

- Prepare and/or submit documents for IRB/IEC and/or sponsor review/approval

- Inform the sponsor and IRB/IEC of any deviations from the protocol and document as appropriate

- Prepare and/or participate in close-out monitoring visit(s)

- safety reporting requirements

- Follow standards for handling hazardous goods

- International Air Transport Association (IATA)

- Ensure timely review of safety data

- Ensure appropriate reporting and documentation of adverse event(s)

- significant milestones in the evaluation of efficacy and safety (e.g., interim analysis result, DSMB review )

- Create, document, and/or implement corrective and preventive action (CAPA) plans

- Ensure compliance with study requirements and regulations

- Prepare, and/or participate in interim monitoring activities (including onsite, remote, and risk-based)

- Clinical Trial Operations (GCPs)

- delegation listing

- Verify that investigational staff is qualified

- Prepare and/or participate in study initiation activities

- Plan, conduct and/or participate in training of the investigational staff

- elements of an effective corrective and preventive action (CAPA) process(es) and plans

- Create, document, and/or implement corrective and preventive action (CAPA) plans

- Identify issues and recommend investigator/site

- corrective actions

- Minimize potential risks to subject safety

- elements of and rationale for monitoring plan(s)

- Follow a study plan

- management plan

- monitoring plan

- Ensure investigator/site protocol compliance

- Ensure monitoring activities are conducted according to plan

- indemnification/insurance requirements

- Minimize potential risks to subject safety

- Identify and/or maintain Essential Documents required for study conduct

- Develop and/or review informed consent form

- monitoring activities (frequency of visits, data review, and follow up)

- Ensure monitoring activities are conducted according to plan

- Prepare, and/or participate in interim monitoring activities (including onsite, remote, and risk-based)

- Document, communicate, and follow up on site visit findings

- pre-study/site selection visit activities

- Evaluate study for feasibility (site determining ability to successfully conduct the study)

- Schedule, coordinate, and/or participate in pre-study site visit

- Ensure appropriate staff, facility, and equipment availability throughout the study

- principal investigator responsibilities

- Ensure and document follow-up medical care for study subjects, as applicable

- Verify that investigational staff is qualified

- Review the Investigators Brochure

- principles of risk based monitoring

- Ensure monitoring activities are conducted according to plan

- Escalate significant findings as appropriate

- Prepare, and/or participate in interim monitoring activities (including onsite, remote, and risk-based)

- project feasibility

- Evaluate study for feasibility (site determining ability to successfully conduct the study)

- considerations

- Ensure appropriate staff, facility, and equipment availability throughout the study

- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB

- roles of various clinical trial entities (e.g., CROs, sponsors, regulatory authority, etc.)

- Verify that investigational staff is qualified

- Escalate significant findings as appropriate

- Coordinate protocol and/or protocol amendments through appropriate approval processes (e.g., IRB/IEC, sponsor, regulatory authority)

- site close-out activities

- Prepare and/or participate in close-out monitoring visit(s)

- Prepare study summary and/or close-out letter for IRB/IEC

- Manage study records retention and availability

- site initiation activities

- Prepare and/or participate in study initiation activities

- Develop or participate in protocol training

- Facilitate site budget/contract approval process

- site selection criteria

- Ensure appropriate staff, facility, and equipment availability throughout the study

- Verify that investigational staff is qualified

- Ensure consistency between the sites standard operating procedures (SOPs) and the study requirements

- staff oversight

- Ensure proper collection, processing, and shipment of specimens (e.g., centrifuge, preparation of slides, freezing, refrigeration)

- Ensure appropriate staff, facility, and equipment availability throughout the study

- Ensure investigator/site protocol compliance

- staff qualifications (site and monitor)

- Verify that investigational staff is qualified

- Develop or participate in protocol training

- Follow standards for handling hazardous goods (e.g., International Air Transport Association (IATA)

- staff training requirements

- Develop or participate in protocol training

- Follow standards for handling hazardous goods (e.g., International Air Transport Association (IATA)

- Plan, conduct and/or participate in training of the investigational staff

- study close-out activities

- Prepare and/or participate in close-out monitoring visit(s)

- Submit documents to regulatory authorities

- Reconcile investigational product and related supplies

- communication documentation requirements (e.g., telephone, email)

- Collect, record, and report accurate and verifiable data

- Maintain study related logs (e.g., site signature log, screening log)

- Develop source document templates

- contract budget negotiations and approval process

- Participate in budget development

- Facilitate site budget/contract approval process

- Reconcile payments per contract (e.g. stipend payments)

- elements of a study budget

- Participate in budget development

- Facilitate site budget/contract approval process

- Ensure appropriate staff, facility, and equipment availability throughout the study

- equipment and supplies use and maintenance

- Perform and/or verify equipment calibration and maintenance

- Ensure proper collection, processing, and shipment of specimens

- centrifuge

- preparation of slides

- freezing

- refrigeration

- Ensure adequacy of investigational product and other supplies at site

- investigational product accountability and documentation requirements

- Maintain accountability of investigational product

- Reconcile investigational product and related supplies

- Monitor investigational product expiration and/or manage resupply

- investigational product characteristics (e.g., mechanism of action, stability, product attributes, etc.)

- Review the Investigators Brochure

- Identify the safety and expected therapeutic effects of the investigational product using various study documents including the protocol and IB

- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies

- investigational product labeling requirements

- Prepare investigational product

- Dispense investigational product

- Monitor investigational product expiration and/or manage resupply

- investigational product packaging

- Instruct subjects on proper use of investigational product

- Assess subject compliance

- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies

- investigational product shipment

- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies

- Maintain accountability of investigational product

- Maintain study related logs (e.g., site signature log, screening log)

- investigational product storage

- Ensure proper storage, dispensing, handling, and disposition of investigational product and related supplies

- Ensure appropriate staff, facility, and equipment availability throughout the study

- Maintain accountability of investigational product

- non-compliance management

- Escalate significant findings as appropriate

- Oversee the management of safety risks at the site (e.g., clinical holds, product recalls)

- Assess subject compliance

- project timelines (e.g. data lock, enrollment period, etc)

- Follow a study plan (e.g., management plan, monitoring plan, etc.)

- Transmit data to Data Management

- Schedule subjects

- purpose of and process(es) for protocol compliance

- Identify issues requiring protocol amendments

- Conduct subject visits

- Assess subject compliance

- sample collection, shipment, and storage requirements

- Ensure appropriate staff, facility, and equipment availability throughout the study

- Manage study supplies (e.g., lab kits, case report forms)

- Follow standards for handling hazardous goods (e.g., International Air Transport Association (IATA)

- subject compliance exam

- Assess subject compliance

- Develop trial management tools (e.g. subject study calendar, source documents, retention material)

- Maintain accountability of investigational product

- subject responsibilities for study participation

- Instruct subjects on proper use of investigational product

- Ensure adequate consent and documentation of the informed consent process

- Assess subject compliance

- subject visit activities

- Schedule subjects

- Conduct subject visits

- Participate in and document the informed consent process(es)

- vendor management

- Manage vendors (Obtain/verify vendor credentials,lab certification/licensure)

- Manage investigational product recall

- Ensure access to source data by authorized parties, and confidentiality by limiting unauthorized access

- data management activities

- Review completed eCRF/CRF

- Transmit data to Data Management

- Manage study records retention and availability

- 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

- Comply with subject privacy regulations

- elements and purposes of data collection tools (e.g., eCRF, EDC)

- Develop trial management tools (e.g. subject study calendar, source documents, retention material)

- Develop source document templates

- Evaluate data collection tools (e.g., case report form (e/CRF), electronic data capture (EDC)) for consistency with protocol

- elements of a final study report

- Manage study records retention and availability

- Prepare study summary and/or close-out letter for IRB/IEC

- Prepare and/or participate in close-out monitoring visit(s)

- elements of and process for data query

- Perform query resolution

- Collect, record, and report accurate and verifiable data

- Review completed eCRF/CRF

- elements of pharmacovigilance (e.g., CIOMS, IDMC/DSMB, safety databases)

- Ensure timely review of safety data

- Collect, record, and report accurate and verifiable data

- Minimize potential risks to subject safety

- essential documents for the conduct of a clinical trial (e.g., paper/electronic, trial master file)

- Identify and/or maintain Essential Documents required for study conduct

- Manage study records retention and availability

- Maintain study related logs

- site signature log

- screening log

- record retention and destruction practices and requirements

- Manage study records retention and availability

- Maintain study related logs (e.g., site signature log, screening log)

- Ensure consistency between the sites standard operating procedures (SOPs) and the study requirements

- source data review (SDR) and source data verification (SDV) purpose and process

- Collect, record, and report accurate and verifiable data

- Perform query resolution

- Ensure and document follow-up medical care for study subjects, as applicable

- source documentation requirements

- Develop source document templates

- Collect, record, and report accurate and verifiable data

- Evaluate data collection tools (e.g., case report form (e/CRF), electronic data capture (EDC)) for consistency with protocol

- study documentation practices (accurate, complete, timely, legible, dated, and identify the trial)

- Develop source document templates

- Evaluate data collection tools (e.g., case report form (e/CRF), electronic data capture (EDC)) for consistency with protocol

- Collect, record, and report accurate and verifiable data

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ACRP-CCRC PDF Questions and Answers

PDF Questions and Answers	: 920 (Complete Set)
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