Attachment5.pdf

Attachment 5: Contractor Assessment Report Quality Assurance Surveillance Plan (QASP)

Performance Indicators and Standards Clinical Trials Monitoring Service

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Task 1: To provide a protocol central patient registration, protocol patient data capture resource and patient data quality control review system for DCTD sponsored Phase 0, Phase 1 and selected Phase 2 clinical trials

Indicators Statement of Work Task Acceptable Quality Level (> 3 – Good)

Contractor Rating

Project Officer Rating

Establish and maintain a web-based protocol patient registry system to be available 24 hours per day, seven days per week with back-up procedures during the core hours of 8:30 a.m. – 5 p.m. ET, Monday-Friday per section A.2 of the SOW.

100% compliance required

0 - Unsatisfactory 5 - Outstanding

Maintain, enhance and revise a computerized protocol patient data capture system that is compatible with the CTEP-ESYS, utilizes CDEs (or eCRFs as developed by CBITT) and permits electronic submission from sites utilizing a web-based environment via internet connection through HTTP or FTP. Compile datasets and electronically export in batch-mode to CDUS on a monthly basis per A.2-9 of the SOW.

100% compliance required

Utilizes procedures for electronic transfer of data that meet appropriate models such as BRIDG, CDISC, HL7 and/or other models as directed by the Project Officer.

100% compliance required

Meets security guidelines as found in the HHS Automated Information Security Handbook per A.4.a of the SOW.

100% compliance required

System Operations

Utilize electronic edit check functionality which enables data fields to be reviewed for accuracy and corrections made before data is transferred to CTMS per A.5 of the SOW.

100% compliance required

0 - Unsatisfactory The data facility experiences excessive down-time (>48 hours unscheduled down-time per year) excluding routine maintenance which is scheduled with advance notification.

1 - Poor Data facility experiences prolonged down-time (> 40 but < 48 hours cumulative unscheduled down-time per year) excluding routine maintenance which is scheduled with advance notification.

2 - Fair Data facility experiences periodic down-time (> 32 hours but < 40 hours cumulative down-time per year) excluding routine maintenance which is scheduled with advance notification.

3 - Good Data facility experiences minimal down-time (> 24 hours but < 32 hours cumulative unscheduled down-time per year) excluding routine maintenance which is scheduled with advance notification.

24 hour availability of data reception facility. A log of down time is maintained and available for periodic review by the Project Officer. A 24 hour advanced notification via email is sent announcing down time for routine maintenance. Unanticipated problems requiring emergency maintenance are announced via email to the Project Officer and all system users. Any other down time occurring without advanced notification is considered unscheduled down time.

4 - Excellent Data facility experiences rare unscheduled down-time (> 16 hours but <24 hours cumulative unscheduled down-time per year), excluding routine maintenance which is scheduled with advance notification.

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5 - Outstanding The data facility is available 24 hours except in extremely rare circumstances (<16 hours cumulative unscheduled down-time per year) excluding routine maintenance which is scheduled with advance notification.

System Maintenance

Maintain a duplicate copy of the database files and programs in a separate remote facility. The duplicate copy must be updated at least every week.

100% compliance required

0 - Unsatisfactory Contractor is not in compliance and is jeopardizing achievement of contract objectives. Reports are submitted by the due date less than 75 % of the time and/or reports do not conform to the requirements outlined in Articles C.2. and F.1. of the contract

1 - Poor Reports are submitted by the due date 75 – 79% of the time and /or reports do not meet conform to the requirements outlined in Articles C.2. and F.1. of the contract.

2 - Fair Reports are submitted by the due date 80 – 84% of the time and/or reports partially conform to the requirements outlined in Articles C.2. and F.1. of the contract.

3 - Good Reports are submitted by the due date 85 - 89% of the time and conform to the requirements outlined in Articles C.2.

and F.1. of the contract

4 - Excellent Reports are timely 90 - 94% of the time and conform to the requirements outlined in Articles C.2. and F.1. of the contract.

Reporting

Contractor provides reports and deliverables as outlined in the SOW as well as ad hoc reports upon request of the Project Officer. Reports for Task 1 include: Monitors Summary, Clinical Studies Summary, Monitors Detail, Clinical Studies Detail, and Special Ad Hoc Reports. Reports conform to the requirements outlined in Articles C.2., Reporting Requirements, and F.1., Deliveries.

5 - Outstanding Reports are timely > 95% of the time and conform to the requirements outlined in Articles C.2. and F.1. of the contract.

Total Score for this Task:

(out of a possible 40 points)

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Task II: Auditing of Phase 0, Phase 1 and Selected Phase 2 Clinical Trials

Conducting Audits

Contractor staffing for conducting audits include a Physician Monitor or Clinical Research Coordinator/CRA with the required training and expertise to oversee the on-site auditing and to perform the tasks as outlined in C.1-2 of the SOW.

100% compliance required

0 - Unsatisfactory Reports are submitted by the due date less than 75% of the time and/or reports do not conform to the requirements outlined in section C.3.a-g of the SOW.

1 - Poor Contractor is delayed in submission of audit reports with only 75-79% of the reports submitted by the due date and/or reports do not conform to the requirements in section C.3.a-g of the SOW.

2 - Fair Contractor submits the audit reports on time 80-84% of the time and/or reports partially conform to the requirements in section C.3.a-g of the SOW.

3 - Good Contractor submits audit reports on time 85-89% of the time and reports conform to the requirements in section C.3.a-g of the SOW.

4 - Excellent Contractor submits audit reports on time 90-94% of the time and reports conform to the requirements in section C.3.a-g of the SOW.

Reporting

Audit reports conform to the requirements outlined in section C.3.a-g of the SOW and are submitted within 10 working days of the date of the audit.

5 - Outstanding Contractor submits audit reports on time > 95% of the time and reports conform to the requirements in section C.3.a-g of the SOW.

(out of a possible 10 points)

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Task III: Co-site Visit Monitoring of NCI Clinical Trials Cooperative Groups, Community Clinical Oncology Program (CCOP) Research Bases, Clinical Trials Support Unit (CTSU) and Selected Multi-institutional Consortiums with Quality Assurance Programs

Co-site Visitor Assignments

Contractor’s co-site visitors attend audits as assigned by the Project Officer and conduct audits in accordance with D.1-4 of the SOW. The Project Officer is informed in advance in the rare event that the contractor staff cannot attend a co-site visit as assigned by the Project Officer.

100% compliance required

0 - Unsatisfactory Reports are submitted by the due date less than 75% of the time and/or reports do not conform to the requirements outlined in section D.5 of the SOW.

1 - Poor Contractor is delayed in submission of audit reports with only 75-79% of the reports submitted by the due date and/or reports do not conform to the requirements in section D.5 the SOW.

2 - Fair Contractor submits the audit reports on time 80-84% of the time and/or reports partially conform to the requirements in section D.5 of the SOW.

3 - Good Contractor submits audit reports on time 85-89% of the time and reports conform to the requirements in section D.5 of the SOW.

4 - Excellent Contractor submits audit reports on time 90-94% of the time and reports conform to the requirements in section D.5 of the SOW.

Reporting Co-site visit audit reports conform to the requirements outlined in section D.5 of the SOW and are submitted within 15 working days from the last date of the audit.

5 - Outstanding Contractor submits audit reports on time > 95% of the time and reports conform to the requirements in section D.5 of the SOW.

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Task IV: Auditing of Investigators Conducting Clinical Trials Sponsored by DCTD at Cancer Centers and Single Institutions

Conducting Audits

The Contractor coordinates schedules, provides personnel and conducts audits at cancer centers and other single institutions as outlined in section E.1-4 of the SOW.

100% compliance required

0 - Unsatisfactory Reports are submitted by the due date less than 75% of the time and/or reports do not conform to the requirements outlined in section E.5 of the SOW.

1 - Poor Contractor is delayed in submission of audit reports with only 75-79% of the reports submitted by the due date and/or reports do not conform to the requirements in section E.5 the SOW.

2 - Fair Contractor submits the audit reports on time 80-84% of the time and/or reports partially conform to the requirements in section E.5 of the SOW.

3 - Good Contractor submits audit reports on time 85-89% of the time and reports conform to the requirements in section E.5 of the SOW.

4 - Excellent Contractor submits audit reports on time 90-94% of the time and reports conform to the requirements in section E.5 of the SOW.

Reporting Draft report is provided within 20 working days after the audit. Final report is provided within 5 working days of the return of the draft report to the Contractor. Reports conform to the requirements in section E.5 of the SOW.

5 - Outstanding Contractor submits audit reports on time > 95% of the time and reports conform to the requirements in section E.5 of the SOW.

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Task V: Quality Assurance Program for International Group/Institution Collaborators

0 - Unsatisfactory Reports are submitted by the due date less than 75% of the time and/or reports do not conform to the requirements outlined in section G.2 of the SOW.

1 - Poor Contractor is delayed in submission of audit reports with only 75-79% of the reports submitted by the due date and/or reports do not conform to the requirements in section G.2 of the SOW.

2 - Fair Contractor submits the audit reports on time 80-84% of the time and/or reports partially conform to the requirements in section G.2 of the SOW.

3 - Good Contractor submits audit reports on time 85- 89% of the time and reports conform to the requirements in section G.2 of the SOW.

4 - Excellent Contractor submits audit reports on time 90- 94% of the time and reports conform to the requirements in section G.2 of the SOW.

Reporting A report is provided within 10 working days after the meeting with the international collaborator. The report complies with the requirements outlined in section G.2 of the SOW.

5 - Outstanding Contractor submits audit reports on time > 95% of the time and reports conform to the requirements in section G.2 of the SOW.

(out of a possible 5 points)

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Additional Administrative Requirements for Tasks I-V

0 - Unsatisfactory Contractor is not in compliance and is jeopardizing achievement of contract objectives.

1 - Poor Contractor’s financial management system is not robust to permit costing out by various activities. Costs per task cannot be obtained.

2 - Fair Contractor’s financial management system is adequate, but there is some difficulty in costing out various activities. Reports may require manual queries and take > 3 days to obtain.

3 - Good Contractor’s financial accounting system appears adequate. Reports may require additional queries, but the data can be obtained within 3 days.

4 - Excellent Contractor’s financial accounting system is robust and enables costing out of various activities without difficulty (greater than 1 day to obtain)

Reporting Financial Management: Contractor shall maintain separate financial accounting procedures for the cost of travel, auditors, outside physician consultants and all combined costs associated with each task and by protocol, type of protocol, institution, treatment versus prevention as per the following sections in the SOW:

A.16, C.5, D.7, E.9 and G.4

5 - Outstanding Contractor’s financial accounting system is robust, enables costing out of various activities without difficulty. Reports are available upon request without delay (less than 1 day)

(out of a possible 5 points)

Total Score for all Tasks: ______________________

Evaluations will be performed semi-annually beginning November 1, 2010.

To be awarded the Award Options, the contractor must receive an average of 4.125 (66 points out of a possible 80) or better in the first two years of Contractor performance. In years three, four, and five the Contractor must receive an average of 4.4375 (71 out of a possible 80) or better in each year to earn the Award Options.