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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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