Core Competency Framework for CRA （2/3）(值得收藏)

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Domain: Clinical Trial Operations (GCPs).

Competency: The purpose of essential documents and the requirements for maintenance and archival.

Expectation: Knowledge of essential documents; Reviews site regulatory file for completeness; Develops follow-up plan with site staff; Reconcile site files with trial master file; Verifies investigator is aware of archiving responsibilities and has plans to comply with requirements.

Entry-Level Monitor: Has an understanding of the required essential documents according to ICH GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates. Collects documents prior to expiration or as corrections/updates are necessary. Determines if additional documents are required when omitted or based on changes to site staff, facilities or processes. Verifies consistency between site files and the trial master file. Determines sites policy for archiving and evaluates against regulatory requirements. Documents archiving location(s) and timelines.

Intermediate Monitor: Has an understanding of the required essential documents according to ICH GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates. Collects documents prior to expiration or as corrections/updates are necessary. Determines if additional documents are required when omitted or based on changes to site staff, facilities or processes. Verifies consistency between site files and the trial master file. Determines sites policy for archiving and evaluates against regulatory requirements. Documents archiving location(s) and timelines. Identifies trends across study sites and brings these issues to the attention of the project lead.

Senior Monitor: Has an understanding of the required essential documents according to ICH GCP Section 8. Reviews site documents and verifies they are accurate, complete, current, and include required updates. Collects documents prior to expiration or as corrections/updates are necessary. Determines if additional documents are required when omitted or based on changes to site staff, facilities or processes. Verifies consistency between site files and the trial master file. Determines sites policy for archiving and evaluates against regulatory requirements. Documents archiving location(s) and timelines. Identifies trends across study sites and brings these issues to the attention of the project lead and provides recommended solutions to resolve issues.

Clinical Lead: Creates a regulatory review checklist containing all applicable documents and versions for the study. Oversee the work of CRAs to verify that all site files are reviewed against the checklist/ICH-GCP required essential documents to verify all study documents have been reviewed, approved, and correctly filed when applicable. Communicates country specific requirements for essential documents and verifies site and CRA compliance. Conducts and/or reviews file audits and resolves trends to prevent deviations, errors or omissions with essential document maintenance.

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Domain: Clinical Trial Operations (GCPs).

Competency: Audit and inspection processes.

Expectation: Preparation, participation, documentation and follow up of audits and/or inspections. Support resolution of Corrective And Preventive Actions (CAPA) resulting from site audits or inspections.

Entry-Level Monitor: Reviews and follows company provided instruction for the role that will be performed in the audit and/or inspection. Provides assistance as requested within the scope of the role. Assist in the development of appropriate risk mitigation plan, demonstrating corrective and preventive action with follow up and within identified timelines with support. Communicate with site personnel, QA and project leadership.

Intermediate Monitor: Reviews and follows company provided instruction for the role that will be performed in the audit and/or inspection. Provides assistance as requested within the scope of the role. Assist in the development of appropriate risk mitigation plan, demonstrating corrective and preventive action with follow up and within identified timelines with limited support. Communicate with site personnel, QA and project leadership.

Senior Monitor: Reviews and follows company provided instruction for the role that will be performed in the audit and/or inspection. Provides assistance as requested within the scope of the role. Mentor junior CRAs in the development of appropriate risk mitigation plan, demonstrating corrective and preventive action with follow up and within identified timelines. Communicate with site personnel, QA and project leadership.

Clinical Lead: Reviews and follows company provided instruction for the role that will be performed in the audit and/or inspection. Provides assistance as requested within the scope of the role. Verify the completeness and accuracy of risk mitigation plan, demonstrating corrective and preventive action with follow up and within identified timelines. Communicate with site personnel, QA and project leadership. Following implementation, verifies the effectiveness of the agreed actions. Communicates lessons learned if and when applicable to the project team.

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Domain: Clinical Trial Operations (GCPs).

Competency: Understands the roles and responsibilities and relationships between the CRA and Investigators, sponsor and EC/IRBs per ICH GCP.

Expectation: Verifies that the investigator has adequate qualifications and resources and these remain adequate throughout the trial period, and that the staff and facilities, including laboratories and equipment, are adequate to safely and properly conduct the trial and these remain adequate throughout the trial period. Develops risk mitigation plans, in the event of a change in adequacy of investigator qualifications or resources.

Entry-Level Monitor: Performs interview with site staff and PI, examines equipment, patient population as it pertains to the protocol and facility and makes a determination about acceptability for the trial. Reviews site policies and practices for adherence to the protocol and ICH-GCP prior to and throughout the study. Conducts ongoing review of site staff, facilities and study documentation to verify staff and facilities remain adequate to perform the trial. When inadequacy is identified, communicate the deficiency to stakeholders and implement corrective action with support.

Intermediate Monitor: Performs interview with site staff and PI, examines equipment, patient population as it pertains to the protocol and facility and makes a determination about acceptability for the trial. Reviews site policies and practices for adherence to protocol and ICH-GCP prior to and throughout the study. Conducts ongoing review of site staff, facilities and study documentation to verify staff and facilities remain adequate to perform the trial. When inadequacy is identified, communicate the deficiency to stakeholders and implement corrective action with minimal support.

Senior Monitor: Performs interview with site staff and PI, examines equipment, patient population as it pertains to the protocol and facility and makes a determination about acceptability for the trial. Reviews site policies and practices for adherence to protocol and ICH-GCP prior to and throughout the study. Conducts ongoing review of site staff, facilities and study documentation to verify staff and facilities remain adequate to perform the trial. Reviews site staff credentials and regulatory audit documents if deficiencies were noted. When inadequacy is identified, communicate the deficiency to stakeholders and implement corrective action. Mentors junior CRAs on assessing investigator site adequacy and achieving compliance.

Clinical Lead: Verifies the CRA team understands the trial requirements for site and investigator adequacy. Performs interview with site staff and PI, examines equipment, patient population as it pertains to the protocol and facility and makes a determination about acceptability for the trial. Reviews site policies and practices for adherence to protocol and ICH-GCP prior to and throughout the study. Oversees initial and ongoing review of site staff, facilities and study documentation to verify staff and facilities remain adequate to perform the trial. Reviews site staff credentials and regulatory audit documents if deficiencies were noted. Mentors others on site suitability. When inadequacy is identified, communicate the deficiency to stakeholders and implement corrective action. Review recommendations from CRAs and participate in the site selection process.

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Domain: Clinical Trial Operations (GCPs).

Competency: The requirements for accurate and complete site source documents. Verification that data reported in the CRF is consistent with source documentation.

Expectation: Performs source data review (SDR) and source data verification (SDV) of critical data, as per the monitoring plan, to verify the site is collecting accurate and verifiable data.

Entry-Level Monitor: Performs source data review (SDR) and source data verification (SDV) of critical data, as per the monitoring plan, to verify the site is collecting attributable, legible, contemporaneous, original and accurate (ALCOA) data. Evaluates site procedures to confirm CRA direct access to all source data. Follows approved procedures when direct access to source data is not available (i.e. certified copies with electronic medical records). Uses critical thinking to review subject charts and supplemental source documentation to determine the accuracy and completeness of data generated for the study. Documents status of review for each subject visit. Writes queries to address inconsistencies with protocol and GCP requirements. Initiates follow-up actions to assist site in achieving compliance. Able to identify non-compliance and implement corrective actions with support.

Intermediate Monitor: Performs source data review (SDR) and source data verification (SDV) of critical data, as per the monitoring plan, to verify the site is collecting attributable, legible, contemporaneous, original and accurate (ALCOA) data. Evaluates site procedures to confirm CRA direct access to all source data. Follows approved procedures when direct access to source data is not available (i.e. certified copies with electronic medical records). Uses critical thinking to review subject charts and supplemental source documentation to determine the accuracy and completeness of data generated for the study. Documents status of review for each subject visit. Writes queries to address inconsistencies with protocol and GCP requirements. Initiates follow-up actions to assist site in achieving compliance. Able to identify non-compliance and implement corrective actions with limited support.

Senior Monitor: Performs source data review (SDR) and source data verification (SDV) of critical data, as per the monitoring plan, to verify the site is collecting attributable, legible, contemporaneous, original and accurate (ALCOA) data. Evaluates site procedures to confirm CRA direct access to all source data. Follows approved procedures when direct access to source data is not available (i.e. certified copies with electronic medical records). Uses critical thinking to review subject charts and supplemental source documentation to determine the accuracy and completeness of data generated for the study. Documents status of review for each subject visit. Writes queries to address inconsistencies with protocol and GCP requirements. Initiates follow-up actions to assist site in achieving compliance. Able to identify non-compliance and implement corrective actions. Mentor junior CRAs on the requirements for source documents.

Clinical Lead: Confirms source data review (SDR) and source data verification (SDV) of critical data, as per the monitoring plan, to verify the site is collecting attributable, legible, contemporaneous, original and accurate (ALCOA) data. Evaluates site procedures to confirm CRA direct access to all source data. Follows approved procedures when direct access to source data is not available (i.e. certified copies with electronic medical records). Uses critical thinking to review subject charts and supplemental source documentation to determine the accuracy and completeness of data generated for the study. Documents status of review for each subject visit. Writes queries to address inconsistencies with protocol and GCP requirements. Initiates follow-up actions to assist site in achieving compliance. Able to identify non-compliance and implement corrective actions. Mentor junior CRAs on the requirements for source documents. Serves as the point of escalation when issues arise with source documents at sites including access requirements, direct access to source data and systems, site staff compliance and closure of issues. Verifies CRAs are reviewing and reporting on all necessary documentation per protocol requirements. Documents the expectations for source documents that CRAs are to review in the monitoring plan. Initiates follow-up actions to assist site in achieving compliance. Able to identify non compliance and implement corrective actions. Mentor junior CRAs on the requirements for source documents. Evaluates source document verification and review process at the project and individual site level to assess risk mitigation.

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Domain: Clinical Trial Operations (GCPs).

Competency: Plans and conducts all types of monitoring visits.

Expectation: Plans, conducts and completes follow-up activities for on-site and/or remote qualification, initiation, interim, central and close-out visits according to written procedures.

Entry-Level Monitor: Adheres to monitoring plan, standard operating procedures, and any other written procedures in reference to conducting all types of monitoring visits. Receives guidance and mentoring to manage complex issues.

Intermediate Monitor: Adheres to monitoring plan, standard operating procedures, and any other written procedures in reference to conducting all types of monitoring visits independently. Manages complex issues with limited support. When not possible to meet deliverables, informs appropriate team/manager.

Senior Monitor: Adheres to monitoring plan, standard operating procedures, and any other written procedures in reference to conducting all types of monitoring visits independently. Capable of managing complex issues. When not possible to meet deliverables, informs appropriate team/manager. Mentors junior CRAs in planning and conducting monitoring visits.

Clinical Lead: Adheres to monitoring plan, standard operating procedures, and any other written procedures in reference to overseeing that all types of monitoring visits are being performed. When not possible to meet deliverables, informs appropriate team/manager and develops contingency plans as necessary. Mentors junior CRAs in planning and conducting monitoring visits. Mentors junior CRAs in managing complex issues and takes the lead on resolving complex issues. Assists team in creating monitoring plan. Procures adequate resources to ensure rate of source data review is adequate to protect patient safety and promote data integrity.

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Domain: Clinical Trial Operations (GCPs).

Competency: Time Management and Prioritization of Work.

Expectation: Evaluates assignments and effectively prioritizes and manages work activities according to study plans.

Entry-Level Monitor: Evaluates assignments, effectively prioritizes and manages work activities according to study plans. Communicates visit activities to stakeholders so that an assessment of activity level can be monitored and forecasted. Shares concerns and requests additional resources to internal team to achieve on-time deliverables.

Intermediate Monitor: Evaluates assignments, effectively prioritizes and manages work activities according to study plans. Communicates visit activities to stakeholders so that an assessment of activity level can be monitored and forecasted. Shares concerns and requests additional resources to internal team to achieve on-time deliverables. Volunteers to help in downtime. Seeks guidance for alternate site assignments.

Senior Monitor: Evaluates assignments, effectively prioritizes and manages work activities according to study plans. Communicates visit activities to stakeholders so that an assessment of activity level can be monitored and forecasted. Shares concerns and requests additional resources to internal team to achieve on-time deliverables. Volunteers to help in downtime. Proactively suggests cost effective site assignment changes.

Clinical Lead: Evaluates assignments, effectively prioritizes and manages work activities according to study plans and needs. Communicates activities to stakeholders so that an assessment of activity level can be monitored and forecasted. Shares concerns and requests additional resources to internal team to achieve on-time deliverables. Effectively assigns sites to CRAs to manage budget, geographical, and experiential needs.

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Domain: Clinical Trial Operations (GCPs).

Competency: Verifies that bio-samples have been appropriately handled, stored, labelled, and shipped.

Expectation: Verifies site staff knowledge and ability to properly collect, handle, store, and ship lab samples. Reviews onsite facilities, records, samples, sample storage, temperature monitoring and equipment calibration records for compliance. Confirms adequate supplies, training and delegation. Develops risk mitigation plans, as needed, to address areas of identified risk.

Entry-Level Monitor: Verifies site staff knowledge and ability to properly collect, handle, store, and ship lab samples. Reviews onsite facilities, records, samples, sample storage, temperature monitoring and equipment calibration records for compliance. Confirms adequate supplies, training and delegation. Develops risk mitigation plans as needed, with support, to address areas of identified risk.

Intermediate Monitor: Verifies site staff knowledge and ability to properly collect, handle, store, and ship lab samples. Reviews onsite facilities, records, samples, sample storage, temperature monitoring and equipment calibration records for compliance. Confirms adequate supplies, training and delegation. Develops risk mitigation plans as needed, with minimal support, to address areas of identified risk.

Senior Monitor: Verifies site staff knowledge and ability to properly collect, handle, store, and ship lab samples. Reviews onsite facilities, records, samples, sample storage, temperature monitoring and equipment calibration records for compliance. Confirms adequate supplies, training and delegation. Develops risk mitigation plans, as needed, to address areas of identified risk.

Clinical Lead: Verifies site staff knowledge and ability to properly collect, handle, store, and ship lab samples. Reviews onsite facilities, records, samples, sample storage, temperature monitoring and equipment calibration records for compliance. Confirms adequate supplies, training and delegation. Reviews risk mitigation plans, as needed, to address areas of identified risk. Provides retraining to project teams to disseminate to sites regarding proper procedures.

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Domain: Clinical Trial Operations (GCPs).

Competency: Verifies that third party vendor data is appropriately collected, transferred, and stored.

Expectation: Verifies site staff knowledge and ability to properly collect, transfer and store study data for third party study vendors. Identifies potential areas of risk and develops risk mitigation plans, as needed, to address areas of identified risk.

Entry-Level Monitor: Verifies site staff knowledge and ability to properly collect, transfer and store study data for third party study vendors. Identifies potential areas of risk and develops risk mitigation plans, as needed, with support to address areas of identified risk.

Intermediate Monitor: Verifies site staff knowledge and ability to properly collect, transfer and store study data for third party study vendors. Identifies potential areas of risk and develops risk mitigation plans, as needed, with minimal support to address areas of identified risk.

Senior Monitor: Verifies site staff knowledge and ability to properly collect, transfer and store study data for third party study vendors. Identifies potential areas of risk and develops risk mitigation plans, as needed, to address areas of identified risk.

Clinical Lead: Verifies site staff knowledge and ability to properly collect, transfer and store study data for third party study vendors. Assists in the development of processes and tools to verify proper processing of study vendor data. Identifies potential areas of risk and coaches/trains project team(s) on the development of risk mitigation plans, as needed, to address areas of identified risk.

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Domain: Clinical Trial Operations (GCPs).

Competency: IP Accountability.

Expectation: Verifies IP accountability. Reviews IP records and reconciles with subject records. Reviews IB reference material.

Entry-Level Monitor: Verifies randomization process by ensuring dispensing procedures are compliant with IB and instructions for use. Verifies adequate IP supplies, and reviews storage, including temperature logs, when needed, Confirms IP is kept in a secure location and adheres to the requirements for storage. Reviews IP records and reconciles with all subject records and system of record, performs compliance calculations. Identifies, escalates and seeks guidance on corrective action for IP issues.

Intermediate Monitor: Verifies randomization process by ensuring dispensing procedures are compliant with IB and instructions for use. Verifies adequate IP supplies, and reviews storage, including temperature logs, when needed, Confirms IP is kept in a secure location and adheres to the requirements for storage. Reviews IP records and reconciles with all subject records and system of record, performs compliance calculations. Identifies, escalates and implements site corrective action for IP issues with limited support.

Senior Monitor: Verifies randomization process by ensuring dispensing procedures are compliant with IB and instructions for use. Verifies adequate IP supplies, and reviews storage, including temperature logs, when needed, Confirms IP is kept in a secure location and adheres to the requirements for storage. Reviews IP records and reconciles with all subject records and system of record, performs compliance calculations. Identifies, escalates and implements site corrective action for IP issues and identifies and escalates trends related IP issues. Mentors junior CRAs on IP accountability processes and verification.

Clinical Lead: Confirms CRA team knows and verifies randomization processes and IP instructions for use. Oversees CRAs to verify adequate IP supplies, storage, records and reconciliation with all subject records and system of record. Serves as the point of escalation for site issues regarding IP. Identifies, escalates and implements corrective action for IP issues and identifies and escalates trends related to IP. Develops action plan to correct IP issues.

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Domain: Clinical Trial Operations (GCPs).

Competency: IP Chain of custody

Expectation: Reviews and verifies documentation of receipt, labeling, storage, dispensing records, return or final disposition of IP.

Entry-Level Monitor: Verifies on site supplies against shipping records and/or system of record. Reconcile site supply with dispensing records. Review documentation of return or final disposition. Identify expiring IP using product labeling and verify IP replacement. Identifies, escalates, and implements corrective action for IP issues with support.

Intermediate Monitor: Verifies on site supplies against shipping records and/or system of record. Reconcile site supply with dispensing records. Review documentation of return or final disposition. Identify expiring IP using product labeling and verify IP replacement. Identifies, escalates, and implements site corrective action for IP issues with limited support.

Senior Monitor: Verifies on site supplies against shipping records and/or system of record. Reconcile site supply with dispensing records. Review documentation of return or final disposition. Identify expiring IP using product labeling and verify IP replacement. Identifies, escalates, and implements corrective action for IP issues. Identifies emerging trends for IP issues and escalates. Mentors junior CRAs on requirements for documented chain of custody of IP.

Clinical Lead: Verifies CRA team verifies on site supplies against shipping records and/or system of record; reconciles site supply with dispensing records; reviews documentation of return or final disposition; identifies expiring IP using product labeling; and verifies IP replacement. Identifies, escalates, and implements corrective action for IP issues. Identifies emerging trends for IP issues and escalates. Develops action plan to correct IP issues.