Core Competency Framework for CRA （1/3） (值得收藏)

=- 1 -=

Domain: Scientific Concepts and Research Design.

Competency: Basic features of the disease or condition under study.

Expectation: Explains the disease process or condition and expected course as well as the treatment options and standard of care. Identifies signs and symptoms of disease. Identifies documentation of diagnosis in subject record. Uses accurate medical terminology.

Entry-Level Monitor: Explains the disease process or condition and expected course. Identifies signs and symptoms of disease. Identifies documentation of diagnosis in subject record. Uses accurate medical terminology. Describes the indication and the associated therapeutic area as well as the treatment options and standard of care. Identifies the relevant study procedures.

Intermediate Monitor: Explains the disease process or condition and expected course. Identifies signs and symptoms of disease. Identifies documentation of diagnosis in subject record. Uses accurate medical terminology. Describes the indication and the associated therapeutic area as well as the treatment options and standard of care. Identifies the relevant study procedures. Summarizes the class of drugs or device and why the product is being developed. Discusses and recognizes alternative treatments.

Senior Monitor: Explains the disease process or condition and expected course. Identifies signs and symptoms of disease. Identifies documentation of diagnosis in subject record. Uses accurate medical terminology. Describes the indication and the associated therapeutic area as well as the treatment options and standard of care. Identifies the relevant study procedures. Summarizes the class of drugs or device and why the product is being developed. Discusses and recognizes alternative treatments. Evaluates risks and benefits of product intervention on the disease or condition.

Clinical Lead: Explains the disease process or condition and expected course. Identifies signs and symptoms of disease. Identifies documentation of diagnosis in subject record. Uses accurate medical terminology. Describes the indication and the associated therapeutic area as well as the treatment options and standard of care. Identifies the relevant study procedures. Summarizes the class of drugs or device and why the product is being developed. Discusses and recognizes alternative treatments. Evaluates risks and benefits of product intervention on the disease or condition. Instructs and guides team through problem solving and mobilizes team to intended goals and solutions.

=- 2 -=

Domain: Scientific Concepts and Research Design

Competency: Product Development Lifecycle and Significance of Design Features in Clinical trial protocols.

Expectation: Defines the different phases of product development. Identifies key protocol sections, critical processes and data, and potential areas for risk. Explains research methodology and purpose of assigned protocol, including primary and secondary endpoints. Describes the rationale for complying with clinical study procedures and their impact in protecting the rights and well being of the patients.

Entry-Level Monitor: Defines the different phases of product development. Identifies key protocol sections, and with assistance, identifies critical processes and data, and evaluates potential areas for risk. Explains research methodology and purpose of assigned protocol, including primary and secondary endpoints. Escalates protocol design questions to project team members.

Intermediate Monitor: Defines the different phases of product development. Identifies key protocol sections, and with minimal assistance, identifies critical processes and data, evaluates potential areas for risk. Explains research methodology and purpose of assigned protocol, including primary and secondary endpoints. Escalates protocol design questions to project team members. Identifies risks associated with clinical trial design.

Senior Monitor: Defines the different phases of product development. Identifies key protocol sections, and identifies critical processes and data, and evaluates potential areas for risk. Explains research methodology and purpose of assigned protocol, including primary and secondary endpoints. Escalates protocol design questions to project team members. Identifies risks associated with clinical trial design. Answers questions regarding protocol design. Serves as resource and mentor on protocol design to team members.

Clinical Lead: Defines the different phases of product development. Identifies key protocol sections and trains/coaches project team on critical processes and data, and potential areas of risk. Explains research methodology and purpose of assigned protocol, including primary and secondary endpoints. Escalates protocol design questions to project team members. Identifies risks associated with clinical trial design. Answers questions regarding protocol material. Serves as resource and mentor on protocol design to team members. Assesses applicability of issues and solutions across study.

=- 3 -=

Domain: Ethical and Participant Safety Considerations.

Competency: Subject Confidentiality and Data Rights and Privacy.

Expectation: Identifies confidential information and complies with global and local laws and guidelines. Is aware of potential scenarios where privacy and confidentiality may be compromised and takes action to mitigate risk.

Entry-Level Monitor: Identifies confidential information and complies with global and local laws and guidelines. With guidance, has some awareness of potential scenarios where privacy and confidentiality may be compromised and takes action to mitigate risk. Identifies and escalates privacy and confidentiality violations, and implements corrective actions.

Intermediate Monitor: Identifies confidential information and complies with global and local laws and guidelines. Is aware of potential scenarios where privacy and confidentiality may be compromised and, with minimal guidance, takes action to mitigate risk.Identifies and escalates privacy and confidentiality violations. Performs root cause analysis and implements preventive and corrective actions.

Senior Monitor: Identifies confidential information and complies with global and local laws and guidelines. Is aware of potential scenarios where privacy and confidentiality may be compromised and takes action to mitigate risk. Identifies and escalates privacy and confidentiality violations. Performs root cause analysis and implements preventive and corrective actions. Serves as a resource and mentor to team members.

Clinical Lead: Identifies confidential information and complies with global and local laws and guidelines. Is aware of potential scenarios where privacy and confidentiality may be compromised and coaches or trains project team on actions to mitigate risk. Identifies and escalates privacy and confidentiality violations. Performs root cause analysis and implements preventive and corrective actions. Serves as a resource and mentor to team members.

=- 4 -=

Domain: Ethical and Participant Safety Considerations.

Competency: Informed Consent Proces.

Expectation: Evaluate the process of obtaining ethical informed consent prior to subject participation and verify informed consent documentation per relevant guidelines and regulations. Is aware of potential scenarios where informed consent may be compromised (e.g. vulnerable population inclusion, revised version(s) of informed consent form) and takes action to mitigate risk. Collaborate with site staff to evaluate withdrawal of consent and verify proper documentation of same.

Entry-Level Monitor: Evaluates the process of obtaining ethical informed consent prior to subject participation and verify informed consent documentation per relevant guidelines and regulations. With guidance, has awareness of potential scenarios where informed consent may be compromised and takes action to mitigate risk. Collaborate with site staff to evaluate withdrawal of consent and verify proper documentation of same. Identifies and escalates informed consent violations and implements corrective actions. Documents and escalates non-compliance issues.

Intermediate Monitor: Evaluates the process of obtaining ethical informed consent prior to subject participation and verify informed consent documentation per relevant guidelines and regulations. Is aware of potential scenarios where informed consent may be compromised and takes action, with minimal guidance, to mitigate risk. Collaborate with site staff to evaluate withdrawal of consent and verify proper documentation of same. Identifies and escalates informed consent violations. Documents and escalates non-compliance issues. Performs root cause analysis and implements preventive and corrective actions.

Senior Monitor: Evaluates the process of obtaining ethical informed consent prior to subject participation and verify informed consent documentation per relevant guidelines and regulations. Is aware of potential scenarios where informed consent may be compromised and takes action to mitigate risk. Collaborate with site staff to evaluate withdrawal of consent and verify proper documentation of same.Identifies and escalates informed consent violations. Documents and escalates non-compliance issues. Performs root cause analysis and implements preventive and corrective actions. Serves as a resource and mentor to team members.

Clinical Lead: Evaluates the process of obtaining ethical informed consent prior to subject participation and verify informed consent documentation per relevant guidelines and regulations. Is aware of potential scenarios where informed consent may be compromised and coaches/trains project team on action(s) to mitigate risk. Collaborate with site staff to evaluate withdrawal of consent and verify proper documentation of same.Identifies and escalates informed consent violations. Documents and escalates non-compliance issues. Performs root cause analysis and implements preventive and corrective actions. Serves as a resource and mentor to team members. Engages in risk management with internal and external stakeholders.

=- 5 -=

Domain: Medicines Development and Regulation.

Competency: Training Compliance

Expectation: Completes and documents organizational and project related training within defined timelines and in compliance with ICH GCP training, local and ISO regulations and requirements.

Entry-Level Monitor: Completes and documents organizational and project-related training within defined timelines and in compliance with ICH GCP training, local and ISO regulations and requirements.

Intermediate Monitor: Completes and documents organizational and project related training within defined timelines and in compliance with ICH GCP training, local and ISO regulations and requirements. Seeks additional training options internally and externally.

Senior Monitor: Completes and documents organizational and project related training within defined timelines and in compliance with ICH GCP training, local and ISO regulations and requirements. Seeks additional training options internally and externally. Mentors and provides project-related training.

Clinical Lead: Completes and documents organizational and project related training within defined timelines and in compliance with ICH GCP training, local and ISO regulations and requirements. Seeks additional training options internally and externally. Mentors and provides project-related training. Identifies the training applicable to the study. Provides additional project-related training, as needed. Verifies study teams compliance with project-related training.

=- 6 -=

Domain: Clinical Trial Operations (GCPs).

Competency: Subject recruitment and retention at the investigator site.

Expectation: Engages PI and site staff in discussions about ethical recruitment and retention efforts, evaluates recruitment and retention strategy and verifies ethics committee approval of subject-facing materials. Is aware of potential recruitment and retention challenges at the study and site level, and takes action to mitigate risk.

Entry-Level Monitor: Engages PI and site staff in discussions about ethical recruitment and retention efforts, evaluates recruitment and retention strategy and verifies ethics committee approval of subject-facing materials. With support, gains awareness of potential recruitment and retention challenges at the study and site level, and takes action to mitigate risk. Identifies and escalates issues, and implements corrective action to recruitment.

Intermediate Monitor: Engages PI and site staff in discussions about ethical recruitment and retention efforts, evaluates recruitment and retention strategy and verifies ethics committee approval of subject-facing materials. Is aware of potential recruitment and retention challenges at the study and site level, and, with minimal support, takes action to mitigate risk. Identifies and escalates issues, and implements corrective action to recruitment. Performs root cause analysis and utilizes available resources to implement corrective and preventive actions.

Senior Monitor: Engages PI and site staff in discussions about ethical recruitment and retention efforts, evaluates recruitment and retention strategy and verifies ethics committee approval of subject-facing materials. Is aware of potential recruitment and retention challenges at the study and site level, and takes action to mitigate risk. Identifies and escalates issues, and implements corrective action to recruitment. Performs root cause analysis and utilizes available resources to implement corrective and preventive actions. Serves as a resource and mentor to team members.

Clinical Lead: Engages PI and site staff in discussions about ethical recruitment and retention efforts, evaluates recruitment and retention strategy and verifies ethics committee approval of subject-facing materials. Is aware of potential recruitment and retention challenges at the study and site level, and coaches/ trains project team on action(s) to mitigate risk. Identifies and escalates issues, and implements corrective action to recruitment. Performs root cause analysis and utilizes available resources to implement corrective and preventive actions. Serves as a resource and mentor to team members. Oversees and analyzes the effectiveness of the patient recruitment plan. Instructs and guides team through problem solving and mobilizes team to intended goals and solutions. Assesses applicability of issues and solutions across study. Engages in risk management with internal and external stakeholders.

=- 7 -=

Domain: Clinical Trial Operations (GCPs).

Competency: Identification, reporting and resolution of suspected misconduct.

Expectation: Identifies the signs of misconduct. Evaluate the severity of issues to assist in determining if misconduct has occurred. Report suspected misconduct in compliance with regulations and company policies. Facilitates corrective action of issues.

Entry-Level Monitor: Identifies signs of suspected misconduct and collect supporting information. Communicate suspicions and facts collected to stakeholders. Seeks guidance on how to facilitate corrective and preventive action plan. Tactfully discusses concerns with the principal investigator (PI) and implement action plan with support from stakeholders.

Intermediate Monitor: Identifies signs of suspected misconduct and collect supporting information. Communicates suspicions and facts collected to stakeholders. Seeks guidance on how to facilitate corrective and preventive action plan. Tactfully discusses concerns with the PI and implements action plan with limited support from stakeholders.

Senior Monitor: Identifies signs of suspected misconduct and collect supporting information. Communicates suspicions and facts collected to stakeholders. Seeks guidance on how to facilitate corrective and preventive action plan. Tactfully discusses concerns with the PI and implements action plan with limited support from stakeholders. Provides support to junior CRAs in collecting information and discussing concerns with site staff.

Clinical Lead: Identifies signs of suspected misconduct and guides the CRA in the collection of supporting information. Communicate suspicions and facts collected to additional stakeholders. Coaches CRA in tactfully discussing concerns with the suspected source of the misconduct and guides the CRA in implementing an action plan. Provides sustained support to quality groups and other stakeholders during the investigation and reporting of misconduct. When and if necessary, participates in discussions with the PI.

=- 8 -=

Domain: Clinical Trial Operations (GCPs).

Competency: Compliance (including any amendments) to ensure protection of the rights and well being of patients, the integrity of the study and the data.

Expectation: Assesses site capabilities and develops plans to support the site to achieve compliance via training, ongoing communication and procurement of relevant study tools. Identifies deviations from the protocol, SOPs, applicable regulatory requirements and other governing study documents/plans. Report non-compliance according to company policies and project plans.

Entry-Level Monitor: With support, assesses site capabilities and develops plans to support the site to achieve compliance via training, ongoing communication and procurement of relevant study tools. Identifies deviations from the protocol, SOPs, and the applicable regulatory requirements. Escalates issues, documents non-compliance in system of record, and confirms ethics committee reporting as required. Protection of study blind, if applicable. Retrains site personnel as needed. Follows up in a timely manner to verify compliance. Implements corrective action(s) with support.

Intermediate Monitor: Assesses site capabilities and develops plans to support the site to achieve protocol compliance via training, ongoing communication and procurement of relevant study tools. Identifies deviations from the protocol, SOPs, and the applicable regulatory requirements. Escalates issues, documents non-compliance in system of record, and confirms ethics committee reporting as required. Protection of study blind, if applicable. Retrains site personnel as needed. Follows up in a timely manner to verify compliance. Implement corrective action(s) with minimal support.

Senior Monitor: Assesses site capabilities and develops plans to support the site to achieve protocol compliance via training, ongoing communication and procurement of relevant study tools. Identifies deviations from the protocol, SOPs, and the applicable regulatory requirements. Escalates issues, documents non-compliance in system of record, and confirms ethics committee reporting as required. Retrains site personnel as needed. Protection of study blind, if applicable. Follows up in a timely manner to verify compliance. Implements corrective action(s). Conducts trend analysis and escalates as needed. Mentors junior CRAs in dealing with non-compliant sites.

Clinical Lead: Assesses site capabilities and develops plans to support the site to achieve protocol compliance via training, ongoing communication and procurement of relevant study tools. Escalates issues, verifies/completes documentation of non-compliance in system of record, and confirms ethics committee reporting as required. Mentors junior CRAs in retraining site personnel as needed. Follows up in a timely manner to verify compliance. Conducts trend analysis, identifies root cause and risk to study, escalates as needed. Retrains project team as needed.

=- 9 -=

Domain: Clinical Trial Operations (GCPs).

Competency: ICH GCP

Expectation: Demonstrates a working knowledge of GCP guidelines. Predicts possible GCP noncompliance based on the trial and site complexities and manages these risks as part of a risk management plan. Identifies and reports ICH GCP non-compliance discovered during monitoring activities. Takes appropriate action designed to prevent recurence of detected deviations.

Entry-Level Monitor: Successfully completes initial and ongoing ICH GCP training. Performs study responsibilites in accordance with ICH GCP. Predicts, with assistance, possible GCP noncompliance based on the trial and site complexities and manages these risks as part of a risk management plan. Monitors investigative sites to verify the trial is conducted and documented in accordance with ICH GCP. Escalates non-compliance and works with site personnel to correct areas of non compliance and prevent recurrence, with support from stakeholders.

Intermediate Monitor: Successfully completes ongoing ICH GCP training. Performs study responsibilities in accordance with ICH GCP. Predicts, with minimal assistance, possible GCP noncompliance based on the trial and site complexities and manages these risks as part of a risk management plan. Monitors investigative sites to verify the trial is conducted and documented in accordance with ICH GCP. Escalates non-compliance and works with site personnel to correct areas of non-compliance and prevent recurrence, with limited support from stakeholders.

Senior Monitor: Successfully completes ongoing ICH GCP training. Performs study responsibilities in accordance with ICH GCP. Predicts possible GCP noncompliance based on the trial and site complexities and manages these risks as part of a risk management plan. Monitors investigative sites to verify the trial is conducted and documented in accordance with ICH GCP. Escalates non-compliance and advises site on creation or revision of site procedures to gain compliance and prevent recurrence. Conducts trend analysis and escalates recommendations for auditing. Participates in preparing audit responses.

Clinical Lead: Successfully completes ongoing ICH GCP training. Performs study responsibilities in accordance with ICH GCP. Predicts, with assistance, possible GCP noncompliance based on the trial and site complexities and documents these risks as part of a risk management plan. Oversees monitoring of investigative sites to verify the trial is conducted and documented in accordance with ICH GCP. Escalatesnon-compliance and mentors junior CRAs on how to advise site on creation or revision of site procedures to gain compliance and prevent recurrence. Conducts trend analysis and escalates recommendations for auditing. Participates in preparing audit responses.

=- 10 -=

Domain: Clinical Trial Operations (GCPs).

Competency: Adequacy of approvals or notifications to Ethics Committees/IRBs and/or Regulatory Authorities.

Expectation: Tracks site approval and expiry dates to anticipate filing and submission timelines. Performs review of competent authority and IRB/IEC documents and submissions. Verify that the appropriate approvals and correspondence with regulatory bodies and ethics committees are documented and filed.

Entry-Level Monitor: Tracks site approval and expiry dates to anticipate filing and submission timelines. Verify that the investigator provides all the required reports, notifications, applications and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial. Able to access and review project repository for competent authority and IRB/IEC documents. Reviews current documents from the repository against site files to assess for any gaps in approval or submissions. Reports deficiencies in approvals or documentation in accordance with the project plan(s).

Intermediate Monitor: Tracks site approval and expiry dates to anticipate filing and submission timelines. Verifies that the investigator provides all the required reports, notifications, applications and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial. Assists with the preparation of Ethics Committee (EC) or Clinical Trial Authority (CTA) documents and respond to EC and/or competent authority queries based on company division of responsibility. Accesses and reviews project repository for competent authority and IRB/IEC documents. Reviews current documents from the repository against site files to assess for any gaps in approval or submissions. Creates a timeline of study activities, IRB/IEC approval dates, and documents approved by the IRB/IEC. Reports deficiencies in approvals or documentation in accordance with the project plan(s).

Senior Monitor: Tracks site approval and expiry dates to anticipate filing and submission timelines. Verifies that the investigator provides all the required reports, notifications, applications and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial. Assists with the preparation of EC or CTA documents and respond to EC and/or competent authority queries based on company division of responsibility. May also be responsibile for maitenance of changing country requirements for EC & competent authority directives, regulations and guidelines. Accesses and reviews project repository for competent authority and IRB/IEC documents. Reviews current documents from the repository against site files to assess for any gaps in approval or submissions. Creates a timeline of study activities, IRB/IEC approval dates, and documents approved by the IRB/IEC. Reports deficiencies in approvals or documentation in accordance with the project plan(s).

Clinical Lead: Oversee the work of CRAs and/or startup personnel to verify that all investigators provides the required reports, notifications, applications and submissions, and that these documents are accurate, complete, timely, legible, dated, and identify the trial. Based on company division of responsibility, verifies the preparation of EC or CTA documents are being done according to local process, and that responses to EC and/or competent authority queries are completed within timelines. May also be responsibile for maintenance of changing country requirements for EC& competent authority directives, regulations and guidelines. Establishes a project repository for competent authority and IRB/IEC documents. Verifies that CRAs review current documents from the repository against site files to assess for any gaps in approval or submissions. Creates a timeline of study activities, IRB/IEC approval dates, and documents approved by the IRB/IEC. Reports deficiencies in approvals or documentation in accordance with the project plan(s).

=- 11 -=

Domain: Clinical Trial Operations (GCPs).

Competency: Identify differing safety events and understand the reporting requirements of each.

Expectation: Differentiates the types of safety events that occur during clinical trials. Identifies, in advance of study initiation, anticipated safety events that may occur. During study, identifies safety events and verifies safety events are reporting in accordance with the protocol on the CRF. Determines whether all safety events are reported within the time periods required by GCP, the protocol, the IRB/IEC, the sponsor, and the applicable regulatory requirement(s).

Entry-Level Monitor: Review the study protocol definition for adverse events, serious adverse events, and other safety events, their reporting timeframes, and reporting processes. Identifies, with assistance, anticipated safety events that may occur. Reviews source records and medical charts for untoward medical events. Confirms that events have been appropriately reported. Discusses issues or questions with the PI and/or medical monitor to verify that medical determinations are made in a timely manner.

Intermediate Monitor: Review the study protocol definition for adverse events, serious adverse events, and other safety events, their reporting timeframes, and reporting processes. Identifies, with minimal guidance, anticipated safety events that may occur. Reviews source records and medical charts for untoward medical events. Confirms that events have been appropriately reported. Discusses issues or questions with the PI and/or medical monitor to verify that medical determinations are made in a timely manner. Identifies project-specific issues or trends with safety reporting and brings these issues to the attention of the project lead.

Senior Monitor: Identifies anticipated safety events that may occur. Reviews source records and medical charts for untoward medical events. Confirms that events have been appropriately reported. Discusses issues or questions with the PI and/or medical monitor to verify that medical determinations are made in a timely manner. Identifies project-specific issues or trends with safety reporting and brings these issues to the attention of the project lead and recommends solutions to address the issues or trends.

Clinical Lead: Verifies CRA team is clear on the protocol definitions and requirements for safety identification and reporting. Creates monitoring tools as needed to assist CRAs in meeting these requirements. Identifies anticipated safety events that may occur and coaches/trains project team on these events. Liases with investigator, medical monitors, and project leadership to resolve areas of uncertainty or concern in a timely manner.