Attachment_6_QASP.pdf

Attachment 6 Quality Assurance Surveillance Plan (QASP)

Performance Requirement Summary

This Quality Assurance Surveillance Plan (QASP) has been developed to further define and measure the performance of the Division of Cancer Prevention (DCP) Protocol Information Office (PIO) Support Contractor. The specific activity, acceptable quality level, and method of surveillance that the Contractor will be measured on are contained in the QASP document. This QASP may be edited to meet changing Government needs.

The QASP is divided into five major sections:

1. Quality

2. Timeline

3. File Storage

4. Clinical Trials Support

5. Other Support Activities

Quality The Contractor will be evaluated on overall quality of document abstraction (e.g., abstracted elements) in NCI Databases (e.g., PIO-CTS, STARTS, etc..) for LOIs, Concepts, Initial Protocol Submissions, and Revisions and Amendments

Timeliness The Contractor will be evaluated on the timeliness of document abstraction

File Storage The Contractor will be evaluated on how well the document files are stored and maintained. The Contractor will be evaluated on the percentage of documents electronically stored.

Clinical Trial Support The Contractor will be evaluated on the timeliness of response letters sent to sites such as Consensus Reviews, Concurrence Review, Approval On-hold, Approval Letters, etc.

Other Support Activities The Contractor will be evaluated on their ability to keep the NCI databases consistent and on timeliness of document abstraction.

Attachment 6: QASP

RFP: N02CN85003-39

The Contractor’s performance will be evaluated on a quarterly basis. The results of the quarterly assessments will be used in preparing the annual rating and the Contractor Assessment Report (CAR). Non-performance will result in not earning the award options and will require re-performing the work at no additional cost to the government.

1a. Quality: Document Abstraction (DCP databases)

The Contractor shall abstract document-related data elements and milestones into DCP databases to support DCP and/or Program Staff with decision making.

Purpose: To support DCP program management and planning.

Performance Indicator: All specified data elements and milestones abstracted completely and accurately.

Acceptable Quality Level: Year 1 = 95%, Year 2 = 96%, Year 3+ = 97%

Method of Surveillance: Random sampling of appropriate documents. Abstraction screens will be checked against the electronic or hard copy file.

Sample Size: Twenty (20) data elements in twenty (20) randomly selected documents.

Sampling and Evaluation Procedures:

Document Selection: DCP PIO Government Staff will generate a list of documents received and abstracted during the period of review.

DCP PIO Government Staff will run a random number list and the first 20 random numbers and their corresponding documents will be selected for review.

Field Selection: DCP PIO Government Staff will select ten fields from the list of fields to review. The list of fields to be reviewed may be changed by the COR if DCP business needs change or if additional fields are added to NCI databases.

Original and Revised Protocols Fields Agent(s) Local Document Number Study Area Blinding Milestone: Document Received by DCP PIO Study Focus Agent Distributor/Supplier Monitoring Method Study Funding Change Type Objectives Study Type DCP Research Group Phase Study Status

Attachment 6: QASP

Document Number Planned Accrual Details Target Organ(s) Document Status Planned Accrual Rate (Monthly) Title Document Type Planned Maximum Accrual Treatment Arm Description

Endpoints Planned Minimum Accrual Treatment Assignment Code IND Principal Investigator (PI) Treatment Assignment Description Lead Organization PI E-mail Version Date Link Concept/LOI to protocol Randomized/non-randomized Local Date Receipt Date

Original and Revised Concepts & Letter of Intent (LOI) Fields Agent(s) Phase Study Type Agent Distributor/Supplier Planned Maximum Accrual Study Status Change Type Principal Investigator (PI) Target Organ DCP Research Group PI E-mail Title Document Number Receipt Date Version Date Document Status Solicited Flag (LOIs Only) Document Type Steering Committee Flag Local Date Study Area Lead Organization Study Focus Milestone: Document Received by DCP PIO Study Funding

Protocol Amendment Fields Agent(s) Phase Treatment Assignment Code Blinding Planned Accrual Rate (Monthly) Treatment Assignment Description DCP Research Group Planned Maximum Accrual Version Date Document Status Randomized/non-randomized Local Date Receipt Date Milestone: Document Received by DCP PIO Study Focus Document Status Target Organ(s)

Analysis of Results: The number of correct fields abstracted divided by the total number of fields evaluated will be used to derive a percentage of correct abstractions. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

Attachment 6: QASP

1b. Quality: Document Abstraction (CTEP database)

The Contractor shall abstract document-related data elements and milestones for NCI Community Oncology Research Program (NCORP) trials into CTEP database currently known as START.

Purpose: To support DCP program management and planning.

Performance Indicator: All specified data elements and milestones abstracted completely and accurately.

Acceptable Quality Level: Year 1 = 95%, Year 2 = 96%, Year 3+ = 97%

Method of Surveillance: Random sampling of appropriate documents. Abstraction screens will be checked against the electronic or hard copy file.

Sample Size: Twenty (20) data elements in twenty (10) randomly selected documents.

Sampling and Evaluation Procedures:

Document Selection: DCP PIO Government Staff will generate a list of documents received and abstracted during the period of review.

DCP PIO Government Staff will run a random number list and the first 20 random numbers and their corresponding documents will be selected for review.

Field Selection: DCP PIO Government Staff will select ten fields to from the list of fields to review. The list of fields to be reviewed may be changed by the COR if DCP business needs change or if additional fields are added to NCI databases.

List of Evaluation Fields Agent(s) NIH Admin Code Receipt Date Agent Distributor/Supplier Phase Review Type CTCAE Version Principal Investigator Solicited Flag Disease Lead Organization Study Area Document Number Local Document Number Study Funding Document Status Local Date Study Status Document Type Participating Organizations Study Type Lead Organization Participation Type Title IND Planned Accrual Details Treatment Arm Code

Attachment 6: QASP

Mail To Planned Accrual Rate (Monthly) Treatment Arm Description Milestone: Document Received Planned Accrual Maximum Treatment Assignment Code Milestone: Sent to CTEP PIO (if applicable) Planned Accrual Minimum Treatment Assignment Description Monitoring Method PMB Dist. Version Date

Analysis of Results: The number of correct fields abstracted divided by the total number of fields evaluated will be used to derive a percentage of correct abstractions. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

2a. Timeliness: Document Abstraction (DCP databases)

Purpose: To streamline the protocol development process by ensuring that information is readily available to support the DCP review and decision-making process.

Performance Indicator: All administratively complete document submissions will be abstracted into NCI databases within 2 business days of document receipt by PIO.

Acceptable Quality Level: 95% for all years of performance

Method of Surveillance: Generating and reviewing a quarterly report of all documents received in the reviewing period.

Sample Size: All documents received within the period being evaluated.

Sampling and Evaluation Procedures:

Sampling: DCP PIO Government Staff will generate a list of documents received and abstracted during the period of review. The report will include the date the document was received; the date the document was abstracted in DCP databases; and the percentage of documents abstracted by the deadline.

Evaluation Procedure: The COR will check the number of documents abstracted by the deadline.

Analysis of Results: The number of documents abstracted within timelines divided by the total number of documents will be used to derive a percentage of efficiency. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

2b. Timeliness: Document Abstraction (CTEP Databases)

Attachment 6: QASP

Purpose: To streamline the protocol development process by ensuring that information is readily available to support the development and tracking of NCORP studies in the CTEP database currently known as START.

Performance Indicator: All administratively complete document submissions will be abstracted into CTEP database within 2 business days of document receipt by PIO.

Acceptable Quality Level: 95% for all years of performance

Method of Surveillance: Generating and reviewing a quarterly report of all documents received in the evaluation period.

Sample Size: All NCORP documents received within the period being evaluated.

Sampling and Evaluation Procedures:

Document Selection: DCP PIO Government Staff will generate a list of documents received and abstracted during the period of review.

The report will include the date the document was received; the date the document was abstracted in CTEP database; and the percentage of documents abstracted by the deadline.

Evaluation Procedure: The COR will check the number of documents abstracted by the deadline.

Analysis of Results: The number of documents abstracted within timelines divided by the total number of documents will be used to derive a percentage of efficiency. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

3. Electronic and Paper Storage: File Management

The Contractor shall maintain electronic and paper files of all documents received.

Purpose: To assure rapid access by DCP staff and contractors to documents.

Performance Indicator: The Contractor shall save all documents (Concepts, LOIs, Protocols, Revisions and Amendments) and document related correspondence on the DCP group drive or other systems as specified by COR. Paper copies should be storage either at PIO contractor staff desks or DCP document room.

Acceptable Quality Level: 98% for all years of performance

Method of Surveillance: Generating and reviewing a quarterly report of all documents received in the evaluation period.

Attachment 6: QASP

Sample Size: All documents received within the period being evaluated.

Sampling and Evaluation Procedures:

Sampling: DCP PIO Government Staff will generate a list of documents received during the period of review. DCP PIO Government Staff will verify documents against electronic files.

Evaluation Procedures: DCP PIO Government Staff will check the number of documents saved electronically against the documents received report.

Analysis of Results: The number of documents filed correctly divided by the total number of documents evaluated will be used to derive a percentage of efficiency. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

4. Clinical Trials Support: Clinical Trial Review Support

The effectiveness of the Contractor to streamline the review process to ensure that DCP timelines are met.

Purpose: Decrease the overall protocol development timeline by ensuring timely reviews.

Performance Indicator: All response letters will be sent to the clinical sites as indicated.

Acceptable Quality Level: Year 1 = 90%, Year 2 = 92%, Year 3+ = 95%

NCORP

• Response letters for original concepts and protocols are sent to research base within eight weeks following receipt of administratively complete document.

• Response letters for revisions are sent to research base within four weeks following receipt of administratively complete document.

• Response letters for amendments are sent to research base within two weeks following receipt of administratively complete document.

Non-NCORP

• Response letters for original LOIs and protocols are sent to research base within four weeks following receipt of administratively complete document.

• Response letters for revisions are sent to research base within two weeks following receipt of administratively complete document.

Attachment 6: QASP

• Response letters for amendments are sent to research base within two weeks following receipt of administratively complete document.

Method of Surveillance: Generating and reviewing a quarterly report of all documents received in the reviewing period.

Exceptions: Documents which are granted extension by the DCP (COR, Medical Monitor or Scientific Monitor) will be exempt.

Sample Size: All responses letters sent in the evaluation period

Sampling and Evaluation Procedures:

Document Selection: DCP PIO Government Staff will generate a list of documents received and abstracted during the period of review.

DCP PIO Government Staff will run a random number list and the first 20 random numbers and their corresponding documents will be selected for review.

Field Selection: DCP PIO Government Staff will select ten fields from the list of fields to review. The list of fields to be reviewed may be changed by the COR if DCP business needs change or if additional fields are added to NCI databases.

Analysis of Results: The number of review letters sent to site within timelines divided by the total number of documents will be used to derive a percentage of efficiency. The COR will provide the Contractor the results of the surveillance on a quarterly basis. The COR will provide the Contractor advance notice of any changes

5a. Other Support Activities: PIO Operational Support

Purpose: The Contractor shall develop and implement a plan to ensure that the NCORP current study status is consistent between CTEP and DCP databases.

Performance Indicator: All NCORP trials current study statuses will be consistent between CTEP and DCP databases.

Acceptable Quality Level: Year 1 = 90%, Year 2 = 92%, Year 3+ = 95%.

Method of Surveillance: Generating and reviewing a quarterly report of all NCORP trials documents received in the reviewing period.

Sample Size: All NCORP trials with status changes during the evaluation period.

Sampling and Evaluation Procedures:

Attachment 6: QASP

Sampling: DCP PIO Government Staff will generate a list of NCORP studies with current study statuses during the evaluation period.

Evaluation Procedure: DCP PIO Government Staff will check the two reports for consistency. The number of consistent NCORP current statuses will be tallied. The COR will provide the Contractor advance notice of any changes.

Analysis of Results: The number of NCORP current study statuses that are consistent between the DCP and CTEP databases divided by the total number of expected consistent NCORP current study statuses will be used to derive a percentage of efficiency. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

5b. Other Support Activity: Preparing Reports

The Contractor shall develop and generate reports as requested to assist DCP Government staff in managing studies. Typical reports may include: overdue documents, study statuses, accrual reports or other reports as requested by the COR.

Example: Overdue Documents

Purpose: To support DCP program management and planning by tracking overdue documents.

Performance Indicator: Contractor generated monthly report tracking study development, implementation and completion that highlights studies with delinquent milestones delivered to Government staff by the 10th of each month.

Acceptable Quality Level: Year 1 = 80%, Year 2 = 85%, Year 3+ = 90%.

Method of Surveillance: Measured by receipt and review of Contractor’s monthly report

Sample Size: All studies without a terminal status (e.g., disapproved, withdrawn, complete, administratively complete or FDAAA complete)

Sampling and Evaluation Procedures:

Sampling: DCP PIO Government Staff will review the Contractor reports for document milestone and study statuses each month when received.

Attachment 6: QASP

Evaluation Procedure: The COR will verify the receipt date of the report by DCP PIO Government Staff. The COR will also verify that delinquent milestones dates are highlighted. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

Analysis of Results: The number of properly highlighted reports received by the due date divided by the total number of requested by COR will be used to derive a percentage of efficiency. The COR will provide the Contractor the results of the surveillance on a quarterly basis.

This plan may be edited to meet changing government needs.

Attachment 6: QASP