Attachment_01_-_Base_Statement_of_Work.pdf

Attachment 01: Base Statement of Work RFP: 75N91019R00029 Page 1 of 11

Attachment 01 – Base Statement of Work Surveillance Epidemiology and End Results (SEER) Program

This is a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. This Statement of Work describes the general scope, nature, complexity, and purpose of the services the Government may acquire under this contract during the specified period.

The specific requirements will be identified in each Task Order Statement of Work.

Scope

The purpose of the National Cancer Institute (NCI) Surveillance Epidemiology and End Results (SEER) Program is to assemble and report annual estimates of cancer statistics that pertain to incidence, prevalence, and patient survival; monitor trends to identify important changes in cancer rates for population subgroups defined by geographic, demographic, and social characteristics; provide information on changes over time in stage of disease at diagnosis and types of therapy, as well as associated changes in cancer patient survival; carry out special studies that provide insight into trends in cancer rates, treatment patterns, and other relevant aspects of cancer control; and provide an infrastructure to support cancer research through its data.

TASK AREA 1 – Programmatic Meetings

a. Contractors awarded Task Order 1 – Core Infrastructure (or future Task Orders as determined by the NCI) shall attend a Programmatic Kickoff Meeting by conference call with the Contracting Officer’s Representative (COR), Contracting Officer (CO), and other Program and Office of Acquisition Staff. The meeting shall be attended by all Contractor key personnel, including at a minimum the Principal Investigator/Program Director and Registry Operations Supervisor/Registry Director/Registry Manager, as well as any other non-key personnel with relevant expertise. The NCI may present an overview of Technical or Business aspects of the SEER program or specific Task Order awarded. The Contractor shall present an overview of the key elements of your Technical and Business Proposals. The Contractor’s presentation shall be in as much detail as you consider necessary to ensure the NCI has a firm understanding of all risks and opportunities associated your technical approach, registry operations, business function, or other considerations.

In addition to the initial Programmatic Kickoff Meeting, the Principal Investigator shall participate in ad-hoc Programmatic Meetings by participating in discussions of best practices and other standardized procedures that will be utilized under various Task Orders discussed in Task Areas 3 – 9 of this Base Statement of Work. The Principal Investigator and/or Registry Director may be required to provide input on potential expansion or improvement of the SEER Program, including the initial planning for upcoming Task Orders under Task Area 7 - Ancillary Studies and Additional Projects.

b. Contractors awarded Task Order 1 – Research Support Only shall attend a Programmatic Meeting by conference call with the Contracting Officer’s Representative (COR), Contracting Officer (CO), and other Program and Office of Acquisition Staff. The meeting shall be attended by all Contractor key personnel, including at a minimum the Principal Investigator/Program Director and Registry Operations Supervisor/Registry Director/Registry Manager, as well as any other non-key personnel with relevant expertise. The NCI may present an overview of Technical or

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Business aspects of the SEER program. The Contractor shall present recommendations for best practices and potential expansion and improvement of the SEER Program. Within 60 calendar days of Task Order award, the Contractor shall submit a Meeting Summary Report. This report shall include, but is not limited to:

i. The Contractor's recommendations for best practices.

ii. The Contractor's recommendations for potential expansion and improvement of the

SEER program.

iii. A summary of the Programmatic Meeting

TASK AREA 2 – Administration Activities

This task area is not anticipated to result in a separate Task Order but will be included as applicable in other Task Orders issued for Base SOW Task Areas 3 – 9.

The Contractor shall perform the following administrative activities, to include but not limited to the following, in accordance with the requirements of each Task Order:

1. Manage staff and resources to effectively provide services for multiple concurrent Tasks Orders.

2. Ensure quality assessment/quality control of the work performed, fostering internal/external communications, tracking activities, and monitoring the budgets of Task Orders.

3. Submit all reports and deliverables in accordance with Section C.2., Reporting Requirements, and

Section F.2, Deliveries.

4. Verify prior to delivery that all electronic reports and deliverables are Section 508 conformant in accordance with the Electronic and Information Technology Accessibility Article in Section H. of the base contract. Regardless of format, all digital content or communications materials produced as a deliverable under any resultant Task Order, shall conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. Remediation of any materials that do not comply with the applicable requirements as set forth in the base contract, shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at http://www.hhs.gov/web/section-508/making-files-accessible/index.html. Federal government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/best-practices, which is recommended for anyone using Microsoft Office 2013 or Office 2016. The following documents are the preferred method of authoring and testing documents produced in Microsoft Office Word 2013 or later:

Microsoft Word 2013 Instructional Guides

a. Basic Authoring and Testing Guide - MS Word 2013, December 2015: plain language guidance outlining minimum steps required to determine Section 508 conformance.

[docx]

b. Basic Authoring and Testing Checklist - MS Word 2013, December 2015: a companion set of yes/no checkpoints. [docx] http://www.hhs.gov/web/section-508/making-files-accessible/index.html https://www.section508.gov/best-practices https://www.section508.gov/sites/default/files/Section%20508%20Basic%20Authoring%20and%20Testing%20Guide%20Word%202013%20v%201%200%2012%2014%202015....doc https://www.section508.gov/sites/default/files/Section%20508%20Basic%20Authoring%20and%20Testing%20Guide%20Word%202013%20Checklist%20v%201.0%20..._0.doc

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c. MS Word 2013—Section 508 Conformance Test Process, December 2015: example conformance process (technical). [docx]

d. MS Word 2013—Section 508 Conformance Test Report Template, December 2015: test process reporting template. [docx]

e. Baseline Tests for Accessible Electronic Documents—MS Word 2013, September 2015:

guidance outlining minimum steps required to determine Section 508 conformance for those creating agency test processes (technical). [docx]

Instructions for authoring and testing Microsoft Excel and files formatted as PDF are also provided at https://www.section508.gov/best-practices and should be used for deliverables in these file formats.

5. Implement the COR approved Task Order Annual Progress Report and applicable draft report as specified Section F.2, Deliveries through the use of the provided template.

6. Implement the COR approved Data Management Plan.

7. Implement the System Review Analysis and Performance Metric Standards in accordance with

Section H. Article of the Base Contract.

8. Implement the Task Order Statement of Work in accordance with HHSAR 352.239‐73(b) Electronic

Information and Technology Accessibility Notice (December 2015).

9. Implement the Standard for Encryption Language requirements in HHS Contracts at:

http://www.hhs.gov/ocio/policy/2009-0002.001s.html. In accordance with Section H. Article of the Base Contract.

10. As defined in the Task Order, Implement the requirements for Federal Information Security

Management Act (FISMA) Moderate controls as set forward in FIPS 199 (http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf), FIPS 200 (http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf) and the most recent version of NIST SP 800-53 (http://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r4.pdf)

11. Implement FAR 52.239-1 Privacy or Security Safeguards (August 1996) in accordance with Section

H. Article of the Base Contract.

12. As applicable to the Task Order, implement the HIPAA Security Rule as:

http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/nist80066.pdf.

13. Conduct the requirements of the Task Order in accordance with (HHSAR 352.237-75) Key Personnel

(December 2015) and (HHSAR 352.224-70 Privacy Act (December 2015)).

https://www.section508.gov/sites/default/files/MS%20Word%202013%20-%20508%20Conformance%20Test%20Process%20v1%200_0.doc https://www.section508.gov/sites/default/files/Word%202013%20Conformance%20Text%20Script%20Reporting%20Tool%20Example%20v%201.0%2012.14.201..._0.doc https://www.section508.gov/sites/default/files/Baseline_Tests_for_Docs_MS_Word_2013_accessibility_v%20%201.0%202.1.2015_1.doc https://www.section508.gov/best-practices http://www.hhs.gov/ocio/policy/2009-0002.001s.html http://csrc.nist.gov/publications/fips/fips199/FIPS-PUB-199-final.pdf http://csrc.nist.gov/publications/fips/fips200/FIPS-200-final-march.pdf http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/nist80066.pdf

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TASK AREA 3 – CORE INFRASTRUCTURE SUPPORT ACTIVITIES

Note: Any Task Order Statement of Work for Task Area 3 – Core Infrastructure Support Activities may include additional detail.

The Contractor shall perform Core Infrastructure activities for the identification and reporting of the following. SEER Program reportability is subject to change at the direction of the COR and currently includes:

All neoplasms diagnosed prior to the year 2001 with a behavior code of '2' or '3' in the International Classification of Diseases for Oncology, Second Edition (ICD-O-2) shall be reportable.

All neoplasms diagnosed in 2001 and later with a behavior code of '2' or ‘3’ in the International Classification of Diseases for Oncology, Third Edition (ICD-O-3) shall be reportable.

The neoplasms in ICD-O-2 or ICD-O-3 shall be reportable for sites other than skin (C44.0-C44.9) including but not limited to vagina, clitoris, vulva, prepuce, penis and scrotum (sites C52.9, C51.0- C51.9, C60.0, C60.9, and C63.2).

If a '0' or '1' behavior code term in ICD-O-2 or ICD-O-3 is verified as in situ, '2', or malignant, '3', by a pathologist, these cases shall be reportable.

Tumors of the brain and central nervous system (C70.0-C72.9, C75.1-C75.3) with a behavior code of ‘0’ or ‘1’ beginning with January 1, 2004 diagnoses shall be reportable.

Cervix carcinoma in situ is not reportable after January 1, 1996. These cases may be submitted to NCI on a voluntary basis.

The following are exclusions based on histology and site:

a. 8000-8005: Neoplasms, malignant, NOS of the skin (C44.0-C44.9)

b. 8010-8046: Epithelial carcinomas of the skin (C44.0-C44.9)

c. 8050-8084: Papillary and squamous cell carcinomas of the skin (C44.0-C44.9)

d. 8090-8110: Basal cell carcinomas of the skin (C44.0-C44.9)

1. The Contractor shall perform the following Core Infrastructure Activities.

a. Casefinding Activities

The Contractor shall:

1) Identify and register all SEER Program reportable cancers diagnosed in residents of the

Contractor’s geographic coverage area based on the county of primary residence at the time of diagnosis.

2) Utilize electronic data capture systems such as electronic pathology (E-Path) reporting where available and participate in NCI efforts to increase electronic data coverage.

3) Establish agreements for electronic data transfer with all major case reporting facilities.

4) Ensure that the needed legal access to the medical facilities and physician offices has been granted through state laws or statutes.

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b. Data Acquisition

The Contractor shall:

1) Ensure that all required data is collected on all newly diagnosed cancers for all residents of the Contractor’s geographic coverage area either directly by the Contractor or submitted by other reporting sources.

2) Abstract each SEER Program reportable case or ensure that SEER Program reportable cases are abstracted by submitting sources in sufficient detail so that each cancer can be classified and coded in accordance with the SEER Program Coding and Staging Manuals.

3) When case data are submitted by other sources, such as hospital-based cancer registries, ensure that the submitted records are tracked and monitored in a manner, which ensures their completeness, timeliness and accuracy. Issues shall be addressed with submitting sources.

4) Ensure that there are follow-back procedures in place. Follow-back activities shall be done as part of other specific functions, including case finding, visual editing, case consolidation, and/or follow-up and generally involve ongoing and iterative updating process. Follow-back activities include but are not limited to:

a) Follow-back activities to reporting facilities, hospital registry staff, physicians or other medical staff, and/or Registry staff intended to clarify missing or conflicting data initially gathered.

b) Maintaining the physician databases.

c) Follow-back to out-of-state or out-of-geographic coverage area facilities to obtain missing data for residents diagnosed and/or treated by out of area facilities. This is generally achieved though data exchange agreements with other State or regional central cancer registries.

d) Follow-back on unknown, missing, and/or inconsistent data.

5) Ensure that all cases are edited and that case consolidation is conducted.

c. Follow-up (Passive and Active) Activities

The Contractor shall have procedures in place to perform vital status follow-up for all active (alive at last follow-up) cancer cases that had a cancer diagnosed on or after January 1st of the first full year of data collection and were residents of the coverage area at the time of their diagnosis.

d. Death Clearance Activities

The Contractor shall have procedures in place for conducting death clearance.

2. Data Submission

The Contractor shall submit data to the National Cancer Institute (NCI) periodically on each resident cancer case diagnosed from the first full year of data collection forward on a schedule and in the format specified by the COR.

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3. Data Quality Requirements

The Contractor shall meet the goals pertaining to data quality.

4. Conduct Quality Control/Quality Improvement Activities

The Contractor shall conduct quality control /quality improvement activities at the Contractor’s registry level and shall participate in project specific activities, including but not limited to:

a. Conduct Registry Quality Control/Quality Improvement Activities

The Contractor shall have policies and procedures for ensuring the quality of collected data and correcting any issues of problems encountered in the collection of data.

b. Conduct Project-Specific Activities

The Contractor shall participate in NCI defined quality control/quality improvement (QI/QC) activities.

5. Conduct Education and Training Activities.

The Contractor shall participate in NCI defined education and training activities as directed by the COR. Training activities include but are not limited to:

a. Conduct Local Level Training

The Contractor shall have policies and procedures for ensuring that Contractor staff have the education and continued training needed to ensure the collection and processing of high-quality data. These plans and procedures shall include a process for continual staff learning using SEER*Educate resources.

b. Conduct Project-Specific Training

The Contractor shall participate in the following NCI defined education and training activities as directed by the COR.

6. Utilize Central Registry Data Management Software (SEER*DMS)

a. The Contractor shall conduct all central registry data management related activities using

SEER*DMS.

b. Unless other provisions are provided and approved by the COR, in coordination with the NCI Information Systems Security Officer (ISSO), SEER*DMS shall be located at an NCI designated hosting facility employing at least FISMA Moderate level controls.

c. The Contractor shall participate in the SEER*DMS Change Control Board (CCB) meetings or any successor to the CCB to discuss modifications and enhancements to SEER*DMS.

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7. Data Security Requirements

a. The Contractor shall ensure that all desktops, laptops, tablets, smart phones, and other mobile devices that house Personally Identifiable Information (PII) are properly protected against the disclosure of this information through loss or theft.

b. The Contractor shall install computer virus detection software on all desktops laptops, tablets, smart phones, and other mobile devices used to access information on behalf of the federal government. Virus detection software and virus detection signatures shall be kept current. The Contractor shall install software/hardware patches and upgrades to protect automated federal information assets.

c. The Contractor shall ensure that there are sufficient physical security procedures in place.

d. The Contractor shall be responsible for reporting all incidents involving the loss and/or disclosure of PII in electronic or physical form. Notification shall be made to the NIH Incident Response Team (IRT@mail.nih.gov) via email within one hour of discovering the incident and shall follow-up as directed by the NIH Incident Response Team.

8. Conduct Data Linkages

The Contractor shall participate in various linkages. These linkages shall require the submission of PII to a trusted third-party honest broker for the purposes of linkage. The Contractor shall coordinate with the COR to ensure that any needed agreements between the Contractor and the trusted third-party honest brokers are in place before the start of any linkage to ensure the establishment or integrity of these processes. The Contractor shall make its best effort to adhere to any project schedules communicated by the COR, including the establishment of required third-party agreements, as to not delay Data Linkage efforts.

9. Conduct Data Exchange Activities

The Contractor shall establish and maintain case-sharing agreements with other State or regional central cancer registries.

10. Provide Reports and Data Requests

a. The Contractor shall periodically transmit population-based cancer incidence and survival data on all patients in the legally described coverage areas.

b. The Contractor shall facilitate access to the data by the public, the media, and private, state, and federal organizations.

c. The Contractor shall facilitate access to the data by researchers from within and outside of the

Contractor’s organization.

11. Perform Other Ancillary Data Collection Infrastructure Activities

a. The Contractor shall attend except when specifically excused by the COR the following face-to-face trainings and meetings of the SEER Program in order to ensure that the Contractor's staff can mailto:IRT@mail.nih.gov

RFP: 75N91019R00029 Page 8 of 11 implement new codes or procedures, and for the exchange of ideas regarding solutions to problems, which arise in tumor registry operations.

1) The Annual SEER Principal Investigators and Managers Meeting

2) The Annual SEER*DMS Users Group Meeting

3) The Annual SEER Quality Improvement Experts Meeting

4) The SEER Advanced Topics Workshop to be held at NCRA

5) Additional NCI/SEER hosted meetings, trainings, and workshops as directed by the COR

The Contractor shall attend the following meetings of other organizations in order to ensure that the Contractor's staff can implement new codes or procedures, and for the exchange of ideas regarding solutions to problems, which arise in tumor registry operations. NCI will not cover travel expenses with NCI funds, nor can NCI provide approval for these meetings.

1) The North American Association of Central Cancer Registries (NAACCR) Annual

Conference

2) The National Cancer Registrars Association (NCRA) Annual Conference

b. The Contractor shall participate in NCI initiated activities on the development and assessment of future plans for the SEER program including short, medium, and long-term goals, objectives, and strategies.

c. The Contractor shall participate in other ancillary data infrastructure activities as defined by Task

Orders.

TASK AREA 4 - SEER*EDUCATE

1. The Contractor shall conduct activities necessary for the development, enhancement, and maintenance of the SEER*Educate system. This shall include but is not limited to:

a. Maintaining the existing SEER*Educate functionality,

b. Ensuring new SEER*Educate functionality is developed and released as needed,

c. Developing and maintaining internal user and management reports,

d. Maintaining existing training content, and

e. Creating and validating new training content.

TASK AREA 5 - SEER*DMS MIGRATION ACTIVITIES

The Offeror should anticipate that a scheduled SEER*DMS migration may require 12 to 18 months to complete.

1. The Contractor shall:

a. Implement COR-approved Migration Plan, and

b. Adhere to the migration as scheduled by the NCI based on the availability of resources and shall commence within 30 days of notification by the COR.

2. Migration activities shall include but are not limited to:

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a. Obtaining all required data use agreements and approvals for data transfer,

b. Participating in requirements analysis for the system infrastructure and technical design,

c. Providing detailed database documentation,

d. Providing periodic data files for use in migration,

e. Responding to questions related to data issues,

f. Participating in requirements analysis for the development of algorithms and configuration,

g. Participating in functional reviews,

h. Participating in beta testing, and

i. Participating in training.

TASK AREA 6 – PATTERNS OF CARE/QUALITY OF CARE STUDIES

The Contractor shall conduct Patterns of Care/Quality of Care (POC/QOC) studies or any successor or supplement to the Patterns of Care Studies. Patterns of Care/Quality of Care (POC/QOC) studies describe, characterize, and compare practice patterns and treatments provided for cancer in different geographic areas of the United States. The studies investigate evaluate state-of-the-art cancer therapies for patients with specified cancer sites. They also evaluate the dissemination of these therapies into community practice, disseminate findings in scientific journals and professional meetings; and work with professional organizations to develop educational or training opportunities to improve the use of state-of-the-art cancer therapy in community practice.

The Contractor shall have the capability or the ability to procure and/or provide services needed to conduct the studies. These activities may include but are not limited to:

1. Describing the use of adjuvant therapy and verifying it with the treating physician or with a unified record,

2. Characterizing the practice patterns in different communities,

3. Describing more completely the use of surgery as treatment,

4. Comparing the patterns of treatment (surgery, radiation therapy, chemotherapy immunotherapy, hormonal therapy) over time and by age, sex, race/ethnicity, and insurance status,

5. Describing comorbidities and the effect of co-morbid conditions on treatment,

6. Describing treatment by hospital characteristics (i.e., profit vs. not for profit, teaching vs.

non-teaching, bed size, etc.),

7. Describing the use of diagnostic tests and compare their use by demographic, variables and geographic region,

8. Describing the use of biomarkers,

9. Matching the patterns of care data with the SEER-Medicare linked files as appropriate by age,

10. Comparing the outcomes in community practice to the outcomes obtained in clinical trials,

11. Complete a designated number of abstracts as indicated in each Task Order Statement of

Work,

12. Verify, by physician contact or by abstracting a unified medical record the therapy given to each patient: radiation, chemotherapy, immunotherapy, and hormonal therapy and other therapies used in the treatment of their selected cancers. In conducting studies requiring physician contact, the Contractor shall coordinate with the COR to either obtain a clinical exemption from the National Institutions of Health (NIH) or obtain clearance for the questionnaire from the Office of Management and Budget, prior to initiation of the study, RFP: 75N91019R00029 Page 10 of 11

13. Conduct quality control activities by re-abstracting a percentage of randomly sampled cases,

14. Abstract data onto data collection forms and enter the data into the abstracting software provided by the NCI or abstract directly into the abstracting software with the appropriate consolidation of data from multiple sources,

15. Appropriately sample new cases registered after the initial sample was drawn.

16. Track study progress, noting successes and failures,

17. Obtain local Institutional Review Board (IRB) approval as appropriate for the Contractor’s

Institution, and

18. If a project or study involves patient interviews or surveys the following shall be required:

1) If a survey instrument is utilized it shall require Office of Management and Budget (OMB) approval, prior to initiation of the study,

2) If biologic material is collected it shall be maintained by the Contractor,

3) In conducting studies requiring interviews of cancer cases, the Contractor shall coordinate with the COR to either obtain a clinical exemption from the National Institutions of Health (NIH) or obtain clearance for the questionnaire from the Office of Management and Budget, prior to initiation of the study and,

4) All provisions of the Health Insurance Portability and Accountability Act shall be complied with in the conduct of these studies.

TASK AREA 7 – ANCILLARY STUDIES AND ADDITIONAL PROJECTS

1. The Contractor shall participate in ancillary studies and additional projects. These may include but are not limited to the following tasks:

a. Obtain IRB approval as required.

b. Conducting Slide and/or Document Reviews as required.

c. Re-abstracting medical records.

d. Providing rapid case ascertainment in support of studies or clinical trial enrollment.

e. Obtaining additional follow-up data that would include information on selected patient and disease characteristics.

f. Linking the registry database with other databases for the purposes of obtaining information relevant to the study of cancer.

g. Collecting additional data items for the purposes of obtaining information relevant to the study of cancer.

h. Conducting studies of various aspects of registry operations.

i. Development of statistical methodologies that provide for the analysis of cancer registry data or that pertain to general cancer surveillance issues.

j. Development of mathematical models that relate to cancer control issues.

k. Conducting studies, which involve patient interviews or surveys to collect information on knowledge, attitudes, outcomes, and practices, related to any aspect of cancer control.

l. If a project or study involves patient interviews or surveys the following shall be required:

1) If a survey instrument is utilized it shall require Office of Management and Budget (OMB) approval, prior to initiation of the study,

2) If biologic material is collected it shall be maintained by the Contractor,

3) In conducting studies requiring interviews of cancer cases, the Contractor shall coordinate with the COR to either obtain a clinical exemption from the National Institutions of Health (NIH) or obtain clearance for the questionnaire from the Office of Management and Budget, prior to initiation of the study, and

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4) All provisions of the Health Insurance Portability and Accountability Act shall be complied with in the conduct of these studies.

m. Conducting studies which involve the collection of comorbidities before and/or after a patient’s cancer diagnosis.

TASK AREA 8 - VIRTUAL TISSUE REPOSITORY

Experience and best practices (http://biospecimens.cancer.gov/practices/) of NCI indicate that the NCI Surveillance, Epidemiology and End Results (SEER) Program can support biospecimen research using a SEER-linked Virtual Tissue Repository (VTR). A SEER VTR, with its population representativeness and large sampling frame is a unique resource for assembling robust collections of biospecimens, even for rare tumors and outcomes. SEER annotation includes demographic and clinical characteristics such as tumor histology, biomarker status, treatment and outcome. Annotation can be augmented with custom data, including detailed treatment, time to recurrence, and other clinicopathologic information.

The contractor shall participate in the Virtual Tissue Repository or any successor or supplement to the Virtual Tissue Repository. Activities shall include but are not limited to:

1. Determining biospecimen availability.

2. Identifying and retrieving biospecimens.

3. Performing custom clinical annotation.

4. Performing pathologist review of biospecimens.

5. Assisting with study IRB clearance.

6. Tracking and shipping deidentified, but linked, data and biospecimens.

TASK AREA 9 - VIRTUAL POOLED REGISTRY

The purpose of the Virtual Pooled Registry (VPR) is to create a capacity similar to the National Death Index without the creation of an aggregated national level cancer patient database. The purpose of the VPR it twofold. It will support a: (1) “one stop shop” process through which an interested researcher could submit one research application and one research file which will undergo one standardized linkage simultaneously at multiple registries, and (2) central registry-to-central registry match to determine shared patients and duplicates.

1. The Contractor shall participate in both aspects of the Virtual Pooled Registry or any successor or supplement to the Virtual Pooled Registry.

2. The Contractor shall coordinate with the COR to ensure any needed agreements between the

Contractor and the trusted third-party honest brokers are in place to ensure the integrity of these processes.

3. Virtual Pooled Registry activities shall include but are not limited to:

a. Installing the NCI provided Virtual Pooled Registry linkage software,

b. Resolution of record linkage discrepancies,

c. Assisting investigators with IRB submissions to obtain requested information,

d. Obtaining necessary IRB clearances, and

e. Participate in a central IRB (CIRB) processes where applicable.

http://biospecimens.cancer.gov/practices/