DRAFT SOW Computing and Data Management Services for the NCI.pdf

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HHS-NIH-NCI-SBSS-PCPSB-75N91019R00007

Computing and Data Management Services for the National Cancer Institute (NCI)

Statement of Work

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government, as needed to perform the requirements set forth below.

SCOPE

The major objective of this requirement is to provide computing services to NCI. The scope is divided into six fully integrated and cohesive task areas. The six task areas are:

Task Area 1. Project Management/Core Services Task Area 2. Data Management Task Area 3. Computer Programming Task Area 4. Computing Infrastructure Services Task Area 5. Website Development Task Area 6. Systems Design and Development Task Area 7. Reports and Manuscripts Preparation Task Area 8. Management of NCI Data Task Area 9. Evaluation of NCI Data and Projects Task Area 10. Technical and Administrative Support Task Area 11. Statistical Methodology and Program Support

TASK AREA 1 - PROJECT MANAGEMENET/CORE SERVICES

1. The Contractor shall manage staff and resources to effectively provide services for multiple concurrent task orders.

2. The Contractor shall coordinate and integrate all the contract activities including staffing decisions, development and implementation of Standard Operating Procedures (SOPs) across task orders, preparing required reports, deliverables and other official documentation, and managing subcontracts and equipment purchases.

The Contractor shall ensure quality assessment/quality control of the work performed, fostering internal/external communications, tracking studies, and monitoring the budget.

3. The Contractor shall develop and implement a management tracking system within six (6) months to enable the Contract Officer’s Representative (COR), and Contractor staff to track communications related to tasks on specific studies.

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4. The Contractor shall provide services in task-centric manner ensuring that similar task orders are performed in a similar standardized manner across all NCI studies and not in a manner specific to one study or NCI Research Group. The Contractor shall share all software in cross cutting expertise areas including data management and programming methods development, and systems and web design and development, shall across contract tasks and similar task orders awarded under this contract. As directed by COR, specific software shall be utilized to perform specific tasks. The Contractor shall assess the level of effort on all NCI studies and provide personnel trained in the use of such software, ensuring maximum use across the Divisions. The Contractor shall distribute and support software developed under this contract to the scientific community via the web, seminars, workshops, and reporting deliverables and provide training for NCI staff as needed.

5. The Contractor shall meet at regular intervals with the COR to review progress and priorities and discuss strategies and plans. The Contractor shall meet with COR and noted technical designees in face to-face and/or teleconference meetings quarterly to review contract performance and discuss project management issues.

6. The Contractor shall ensure that' any transitioning of staff on tasks shall be performed with minimal impact on delivery of work.

7. The Contractor shall be available within 24 hours’ notice for meeting to (1) strategize programming options that best fit the task or project and (2) monitor results of the programming strategy.

TASK AREA 2 - DATA MANAGEMENT

The Contractor shall provide data management services including manual and automated secure and standardized processes to enter, store, and retrieve data and documentation for NCI research studies. The service capabilities shall be flexible and adaptable to accommodate diverse and evolving requirements of NCI studies.

1. The Contractor shall provide data management services for NCI studies that 1) vary by size and study design; 2) include diverse data variables; 3) include data from diverse sources; and, 4) involve data exchange with multiple collaborators/repositories described as follows:

A. Diverse Sizes and Study Designs

The Contractor shall provide data management services for:

1. Population-based and laboratory-based studies.

2. NCI studies with diverse study designs including cohort, cross-sectional, case control, nested cohort, and randomized clinical trials. Some of the cohort studies are large (tens of thousands of individuals); others are small (less than

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100 individuals) with dense evaluation of exposure or intervention and endpoints.

3. Data from biospecimen assays performed in the laboratory to measure different exposures, biomarkers, and/or disease outcomes.

4. Observational studies, in which potential risk factors or biomarkers of disease are identified without intervening in individuals' care to affect disease outcome.

The Contractor shall maintain data from longitudinal cohort studies (prospective and retrospective), with multiple records per patient for repeated observations of exposure and outcome variables measured over long periods of time. The Contractor shall retain data heterogeneities in repeated data collection patterns/times and missing data in accordance with the planned and/or established study guidelines.

5. Clinical and population studies including those that evaluate the efficacy of screening procedures for disease outcomes or those that evaluate drug efficacies for cancer prevention.

B. Diverse Data Variables

The Contractor shall provide data management services for:

1. Studies with diverse variables, including environmental exposure (radiation, nutrition, microbial, hormonal, and others), occupational exposure/industrial hygiene parameters, demographics, medical history (i.e. clinical signs, imaging), and high-dimensional molecular data from biospecimens.

2. Measurements of environmental variables such as chemical and radiation exposure obtained from public surveys of sources including soil, air, and water along with the corresponding geographical coordinates and time of collection.

3. Measurements of dietary variables including data on diet (food frequency questionnaires or 24 hour recalls and other types), supplement use, body mass indices and waist to hip ratios, physical activity including monitor data, and blood-and tissue-based analyses.

4. Microbial exposure variable data including morphological and biochemical characterizations and human microbiome sequences.

5. Medical history data including clinical workup, pathology reports, family history, imaging, and clinical laboratory test results.

6. Specific complexities associated with high-throughput genetic or molecular research investigations where a large number of covariates (millions of data

Small Business Sources Sought Page 4 of 16 points resulting in gigabyte-sized data files) including genes, proteins, or metabolites are to be simultaneously collected. The Contractor shall:

a. Be prepared to provide data management for studies with increasing size and complexity with data from newer molecular technologies including newly emerging sequencing technologies.

b. Implement methods to store and manipulate data in compressed formats e.g., binary formats. The data storage formats vary with the data sources and- analytic software.

c. Implement methods to ensure that the data systems being used employ fast read/write capabilities and possess storage/processing capabilities to enable efficient storage and retrieval of the data.

C. Data from Diverse Sources

The Contractor shall provide services to capture data from diverse sources including data collection instruments such as questionnaire surveys, hospital/clinic medical record databases [for example, the Veteran's Administration (VA) health system, Health Maintenance Organizations (HMOs) and Medicare] , pathology reports, laboratory results, death certificates, public records of environmental exposures, or other databases including cancer registries and the National Death Index, which require standardized processes for data collection.

1. The Contractor shall collaborate with such organizations as referenced above to assist in data abstraction or the development of workflows to collect the data required for NCI studies, as requested by the COR.

2. The Contractor shall collect data via a web-based system and/or using a file transfer protocol system and/or from hardcopies as requested by the COR. The Contractor shall provide services in designing the data collection instruments and implementing procedures to ensure that these are being administered and utilized appropriately as directed by the COR. The Contractor, in coordination with the COR, shall ensure that the collection instruments:

a. Include pertinent fields and are logically structured so the resulting data are amenable to performing analyses

b. Are accompanied by supporting documentation to assist in ensuring the accuracy of the collection instruments for responses from subjects.

3. The Contractor shall provide limited coding services for categorizing information based on demographic, reproductive, medical, radiation, occupational, or lifestyle factors as well as complex laboratory or genetic data.

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The Contractor shall provide instruction manuals to insure consistent coding.

Coding shall be consistent to minimize errors in transcription and to enable automated entry where possible.

D. Data Exchange with Multiple Collaborators/Repositories

The Contractor shall provide services for accurate and efficient data exchange between NCI investigators and its multiple national and international collaborators, as directed by the COR. NCI collaborators include large cooperative groups or research consortia. The Contractor shall also facilitate routine exchange of data with data repositories. For the Division of Cancer Prevention (DCP) studies non-DCP databases that DCP exports to and imports from include state cancer registries, the National Death Index, and the Surveillance, Epidemiology and End Results (SEER; http://seer.cancer.gov/) database.

1. The Contractor shall be prepared to provide services for data exchange with other ad hoc repositories, as directed by the COR. Therefore, the Contractor shall:

a. Perform data import/export in a variety of data file formats to be interoperable with collaborators' data systems. In some cases, the Contractor shall collaborate with the owners of these data systems to enable automated import/export without the need for Intermediate files.

b. Harmonize data elements in accordance with NCI investigators' requirements to allow for pooling of data across studies, as directed by the

COR.

c. Provide data processing and management services for access to genomic, proteomic, and other biomarker Information from designated resources as requested by the COR.

d. Implement processes for semantic interoperability (ensuring that the terminologies match) and syntactic interoperability (ensuring that the transfer formats match), both of which are required for pooled and meta-analyses.

2. The Contractor shall coordinate with other Contractors and NCI collaborators to ensure accurate and efficient transfer of study data collected by these Contractors and collaborators. The Contractor shall implement standardized communication processes designed to ensure timely and accurate data capture and transfer.

http://seer.cancer.gov/)

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3. The Contractor shall implement data management techniques that are optimized to enable efficient data retrieval for downstream integrative analyses of data from studies with complex and evolving study-designs, complex variables, and high-dimensional data variables as described above.

4. The Contractor shall implement comprehensive, periodic, and coordinated quality control (QC)/quality assurance (QA) plans and update/versioning strategy to accommodate the volume and diversity of data collected, ongoing updates, and to enable diverse types of data usage. The Contractor shall:

a. Check the source data for completeness, validity, duplication, and inconsistencies, and address these issues with the data source provider prior to storing the data.

b. Implement standard procedures to monitor the quality of the data, with processes to monitor the effectiveness and efficacy of these procedures, and the results of these tasks reported to the COR in a timely manner.

c. Employ QC/QA measures relevant to different types of data, as well as functional assays and data from clinical genetics and high-throughput genomics studies and generate QC statistics to enable accurate and informed use of the data. Some examples are consistency checks for questionnaires and abstracted data; the use of call rates; and reproducibility measures for biochemical assays, including coefficients of variation and intra-class correlation coefficients.

d. Ensure that the associated QC data are easily accessible to NCI staff via summary statistics and graphical representations to enable thorough evaluation of the data quality. QC summary statistics include the percent of successfully genotyped samples; the average genotyping success rate; the duplicate sample error rate; gender discordance; the appearance of relatedness in what are supposed to be unrelated individuals: quality differences between cases and controls arising from differences in collection, handling, and assaying procedures: etc.

E. Develop a searchable, public-facing online catalog for NCI biobanking programs:

1. Provide a searchable, comprehensive online database of biospecimens and associated annotation, together with a minimal set of biospecimen annotation.

2. The Catalog will serve the purpose of connecting researchers with available biospecimens.

3. The Catalog will display the access policies and application forms to utilize the biospecimens.

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4. The Catalog will be an essential function of NCI biobanking programs, ensuring that the collected biospecimens are visible to the research community and encouraging the use of the biospecimens in research.

5. The Contractor shall participate in meetings with the NCI and other parties as directed by NCI, to develop system requirements and identify data integration needs and solutions for the Catalog; develop the implementation plan for delivering the Catalog; obtain certifications and accreditations necessary for the operation of the Catalog; develop and implement and deliver the Catalog;

develop API’s (Application Programming interfaces) as needed to integrate with Clinical Data Management Systems and biorepository Laboratory Information Management Systems; and operate and maintain the online catalog system.

TASK AREA 3 - COMPUTER PROGRAMMING

1. The Contractor shall provide computer-programming services for NCI studies.

Specifically, the Contractor shall:

A. Implement industry-standard security measures (e.g., encryption, role-based security, etc.) to ensure data privacy, e.g., Health Insurance Portability and Accountability Act (HIPAA), and Privacy Act.

B. Provide efficient data backup and recovery procedures to prevent accidental loss of data. Specifically, the Contractor shall:

1. Ensure that the data are backed up on a daily basis with hourly logs kept to track database activity in between the time tapes are run.

2. Implement Standard Operating Procedures (SOPs) to check the logs periodically and test the backup and retrieval procedures.

3. Implement backup procedures that are reliable, secure, automated, and scalable.

4. Coordinate the transfer of backup tapes to ensure data is protected against natural or man-made disasters and manage the transfer of data to a secure off site facility.

5. Work with other NCI and NIH organizations to coordinate activities associated with special mandates involving data backup and recovery.

C. Ensure that the source data files, captured data, and analytic data files (described under Task 3, subtask b, are well documented to ensure efficient and informed usage of the data.

D. Store biomarker data with accompanying comprehensive annotations, such as

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The sources and versions of the annotations used for the analysis shall be documented and readily available when requested by the COR.

E. Implement standardization and harmonization of strategies and processes to promote data uniformity and high-throughput usage and aid reuse of the data in pooling studies, meta-analyses, reproduction of analyses, and integrative analyses of different variable types. These strategies and processes shall be optimized to enable efficient and accurate retrieval for downstream use of the data.

F. Perform periodic evaluation of data management. These evaluations shall be specified in task order issued under this contract, documented in the Annual Task Order Report and shall include the following subcategories of tasks: a) Preparation of datasets for derived variables and biospecimen inventory reports; b) Computer programming; c) Reports generated; and, Services for biomedical computing.

2. Preparation of Analytic Datasets for Derived Variables

The Contractor shall:

A. Generate analytic files of datasets with diverse variables from diverse study designs and data sources described earlier.

B. Develop data dictionaries with detailed description of the variables, accompanied by cross tabulations of the variable values in the analytic files, in a format as designated by the COR.

C. Provide data harmonization services to create pooled datasets in which data from multiple studies are harmonized in accordance with COR specifications to ensure comparability. The Contractor shall pre-process the variables appropriately to account for differences from heterogeneity in data sources, type of measurement (categorical versus quantitative) levels of measurement, and validity of the measures, etc., before they can be combined for analysis.

D. Document datasets to include the version of the source data used, exclusion-and inclusion-criteria, all pre-processing steps, analysis methods used, and differences between the versions of data files if multiple versions of the files were provided.

The dataset, source code, and documentation, including the data dictionary, shall be archived to be easily accessible to NCI and other scientific researchers.

Standard procedures shall be developed with input from the COR and followed for file nomenclature (to include appropriate information such as the date of preparation, data source version used, source code version, requester name, etc.)

to promote efficient and effective data transfer to subsequent data requestors.

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E. Design the structure of the datasets to enable the reuse of data without the need for re-creation of datasets for various possible downstream analyses, which may require manipulations such as merging of data from multiple studies with complex time-dependent data and missing data handling procedures.

F. Verify with the COR that the data requestor has been granted the necessary privileges and approvals to use the dataset before preparing and providing the dataset.

3. Programming Software and Services

The Contractor shall provide programming services in languages including SAS, R.

MatLab [and its freeware version], S-Plus, Stata, SPSS, C++, and FORTRAN as requested by the COR. The Contractor shall develop computer programs using diverse classical and molecular data analysis algorithms and modules implemented in those languages. The programming services shall be adaptable to meet the changing analysis needs of NCI.

The Contractor shall automate file formatting for analyses in various statistical packages, to implement new algorithms, to convert code from one statistical language to another, and to bundle analysis modules to enable streamlined multi-step analyses.

Such software shall be computationally efficient, well documented, and created in a modular fashion, so that components can be reused across studies, where appropriate

1. Computer Programming for Routine Data Analysis

The Contractor shall implement computer programs for sample size and power calculations, identification of confounders, cancer risk prediction, and survival projections. These computer programs include implementing:

A. Tests of significance including Chi-square, Student t and Wilcoxon t, Fisher's exact, and Kolmogorov-Smirnov tests, ANOVA, ANCOVA which are routinely used for univariate analyses.

B. SAS procedures such as Linear and Logistic Generalized Linear Modeling (GLM) procedures to identify and control for the effects of confounding factors in multivariate analyses.

C. Correlation and regression methods for analyses of case-control studies (e.g., logistic regression, polytomous regression) and cohort studies (e.g., Poisson regression and Cox Proportional Hazards regression); tests for trends, interactions, and joint effects may be necessary.

D. Techniques for missing value imputations.

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E. Methods for data from repeated measurements in longitudinal data.

F. Calculation of incidence, prevalence, mortality, odds ratios, relative risks, standardized mortality and incidence ratios (SMR/SIR), and temporal trends and survival (examples of survival analyses include Kaplan-Meier estimates and time dependent Cox proportional hazards regressions).

G. Graphical representations of population and laboratory data for effective visualization of trends and patterns.

2. Molecular and Biomarker Data Programming

The Contractor shall provide programming services for manipulation and analysis of molecular and biomarker data. The programming shall vary over time with availability of newer molecular technologies and methods to perform analyses of the data from these technologies. The Contractor shall:

A. Develop complex modeling and simulation computer programs to implement evolving computational methods to analyze high-dimensional data resulting from evolving molecular technologies used in NCI studies.

B. Maintain and enhance an existing extensive master file that links the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial analytic database to each participant's bio-specimen inventory. This master file incorporates the complex rules for specimen availability required by the PLCO Etiologic and Early Markers Studies (EEMS) Steering Committee. Contractor shall participate with the COR in the complex process involved in determining study case definition, control definition, inclusion criteria, case control matching criteria and bio-specimen requirements. Contractor shall coordinate with investigators, as directed by the COR, to facilitate specimen delivery, batching, and documentation.

3. Programming Statistical Methods Development

Contractor shall implement new statistical methods/models for data analysis and study design to address questions in cancer prevention. Such implementation of new methods shall require programming in SAS, R, MATLAB, Fortran, and/or C++ and simulations to test theories underlying new algorithms. The Contractor shall implement multiple simulations designed to validate the proposed methods or to compare these with existing ones. The Contractor shall use optimizations such as parallel processing on multiple Central Processing Units (CPUs) to ensure computational feasibility of memory intensive software programs. Examples include:

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A. Implementing software programs to compute sample sizes needed for innovative study designs or study objectives such as evaluating early detection biomarkers or novel phase II chemoprevention trials.

B. Providing programming for innovative study designs or developing new methods of analysis such as methods to analyze measurement error in dietary assessment instruments.

TASK AREA 4 - COMPUTING INFRASTUCTURE SERVICES

The Contractor shall provide a computing infrastructure and associated services.

1. The Contractor shall ensure that the infrastructure is designed to:

A. Be scalable and capable of servicing numerous biostatisticians, prevention researchers, programmers, and systems developers.

B. Provide management, administration, and engineering services for diverse fileserver operating platforms, including (but not limited to) Linux, Windows, VMware, and Network Appliance Corporation.

C. Ensure limited and controlled physical access.

D. Include built-In redundancies for components that are critical for the performance of the contract.

2. Contractor infrastructure and computer support services shall include:

A. Providing a Help Desk Monday through Friday from 8:30 am to 5:00 pm EST for users of the NCI developed analytical applications residing on this infrastructure monitoring the performance of the computing environment and recommending to the COR enhancements and upgrades as required.

B. Renewing licenses for all software installed on the infrastructure.

C. Monitoring, auditing, and policy enforcement of physical, network, and user-level security of the system and resources.

D. Regular maintenance procedures that impact the use of the resource during nights or weekends.

E. Use of NIH/CIT computer facility or program development and data processing.

Note: NCI will bear the expense for use of the NIH/CIT computer facility.

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TASK AREA 5 - WEBSITE DEVELOPMENT AND MAINTENANCE

The Contractor shall provide services for the design, development, and maintenance of NCI web applications, public-facing Internet sites, and secure portals to facilitate collaboration activities. Study-specific websites shall be designed to collect study data and/or to disseminate information regarding specific studies and their resources (including data, images and specimens). Secure portals shall be designed and maintained to facilitate collaborations and exchange information between specific NCI and non-NCI collaborators. NCI projects for which the Contractor shall provide web and maintenance services include PLCO, National Lung Screening Trial (NLST), Interactive Diet and Activity Tracking in AARP (iDATA), NCI Community Oncology Research Programs (NCORPs), DCP Dashboard, PIO Clinical Trial System (PIO-CTS), and NCI Biobanking programs.

1. Employ industry standard processes to gather requirements, design, develop, and maintain web sites, including the use of templates in a manner that enables their reuse with minimum effort when designing new sites.

2. Provide services for integration of custom web applications.

3. Coordinate with NCI staff to maintain websites that are managed by multiple entities.

For example, DCP's public-facing Internet site (http://prevention.cancer.gov) website is located both within and outside the NCI firewall. The Contractor shall participate in the task of web content management that is shared between DCP staff, staff on this contract, and other NCI IT support Contractors.

4. Implement the web sites in compliance with federal regulations and adhere to NCI templates.

5. Incorporate standards of Section 508 of Rehabilitation Act into all website projects.

Task Area 6 - SYSTEMS DESIGN AND DEVELOPMENT

The Contractor shall: (1) provide systems' analysis, design, programming, testing, and documentation; (2) develop new systems and/or maintain and enhance existing computer systems, including web-based systems; (3) develop systems that ensure data accuracy and incorporate measures required to ensure data privacy and security in accordance with federal guidelines; (4) where possible, utilize and customize existing open-source resources to address the Division's IT needs; (5) maintain/develop systems for study data management, data analysis, and science administration processes such as budget tracking.

The Contractor shall follow software and systems development principles and best practices for software and system development maintenance, and IT governance in accordance with

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Government regulations. The Contractor shall:

1. Design all applications to eliminate unnecessary data redundancy and promote system efficiency and high performance.

2. Develop all Web-based applications to provide services for the relevant versions of Microsoft Internet Explorer, Mozilla Firefox, Safari and other browsers and operating systems.

3. Design systems to enable possible integration and interoperability with NCI-wide system harmonization initiatives. The Contractor shall integrate appropriate models for biomedical.

4. Utilize, re-use, and enhance existing software unless the COR determines this is not in the best interest for NCI.

5. Address inquiries regarding the systems on a case-by-case basis.

6. Maintain a Manual of Operating Procedures (MOOP) detailing the operational procedures/business. The Contractor shall develop and provide training and educational programs and materials for custom software developed or modified on this contract.

7. Make available all new software developed under this contract under an Open Source Initiative (OSI; http://www.opensource.org/) approved license to the scientific community. Distribution of open-source software shall be accomplished via a community site, such as GForge (http://gforge.nci.nih.gov/), Source Forge (http://sourceforge.net/), and Google Code (http://code.google.com/).

8. Share information, processes and data models, documentation, and training materials related to software developed under this contract with other components of the NCI and oncology community for system development, integration and/or technology acceptance.

9. Consult with the COR regarding potential risks to the development, integration, implementation, and maintenance of all software and hardware required for any new project.

10. Develop and implement a process to validate all new custom software or custom software upgrades to ensure that it does not adversely impact (e.g. costs, security, unanticipated interruption or downtime, loss of data) other NCI custom applications.

11. For any new software projects that employ an industry accepted software development methodology, the Contactor shall provide a Software Development Plan that includes requirements gathering, software lifecycle management, modern source code and configuration management, testing, and deployment.

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12. Develop metrics to monitor defects, including the number of defects; defect impact; time from defect creation until removal; and defect removal efficiency. The Contractor shall coordinate this activity with change management priorities that will ensure effective legacy migration and future system transformation.

13. Maintain all supplier agreements to provide services for software and hardware to ensure server functionality and optimal fault tolerance. The Contractor shall assure that NCI systems remain continuously operationally available 24 hours a day, seven days a week. Any system maintenance or updates that will interrupt the operation of the systems shall be performed outside of the normal working hours (weekdays 6:00 am to 6:00 pm ET) to ensure minimal disruption. Any emergency updates that need to be performed during normal working hours shall be performed only upon approval of the

COR.

14. Perform all periodic operational tasks required to maintain the proper level of performance and data integrity of all relevant NCI systems. This shall include all design and/or redesign of system programs; data quality; change management;

configuration management; requirement analysis; verification and validation; initial coding; revision; testing; debugging; documentation; training for all system software and hardware; and systems and/or data integration

15. Use a formal process for collecting, tracking, assessing, approval and implementation of change requests, which shall originate from the COR. The COR must approve any change to an active application that requires the equivalent of 40 hours or more to complete prior to the Contractor’s change. The Contractor shall coordinate and monitor this activity to ensure effective legacy migration and future system transformation.

16. Maintain and improve software and hardware assets that require periodic updates including procurement activities prior to the expiration of any asset or its license or certification needed to provide services for optimal performance of NCI systems.

Task Area 7 – REPORTS AND MANUSCRIPTS PREPARATION

1. Provide support for preparation of NCI reports that may draw on information obtained from one or more data systems it manages.

2. Create reports in response to governmental or other organizations requests for information and data, for example, Data Safety and Monitoring Board (DSMB), Food and Drug Administration (FDA), Freedom of Information Act (FOIA) requests, etc.

3. Provide support for manuscript preparation and other publications.

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4. Assist with the development of materials such as visual aids, manuals, monographs and other documents as needed to meet the changing needs of NCI.

Task Area 8 – MANAGEMENT OF NCI DATA

The Contractor shall:

1. Provide data management support including appropriate user? manuals with automated secure and standardized processes to enter, store and retrieve data and documentation for a wide variety of NCI studies, and epidemiology studies.

2. Provide support for studies with diverse variables, including environmental exposure, occupational exposure/industrial hygiene parameters, demographics, medical history, and data from biospecimens.

3. Interface with the NCI Biorepositories to facilitate biospecimens management and the utilization of the biospecimens in coordination with NCI program staff.

4. Implement innovative technologies to collect, store and manipulate data in a variety of formats which shall vary with the data sources.

5. Provide efficient data backup and recovery procedures to prevent accidental loss of data.

Data shall be backed up on a daily basis.

6. Provide data quality control and validation to meet interim quality checks “sanity checks” upon input into the Contractor’s systems. Interim quality checks shall include, at a minimum:

A. Clinical data shall be captured in such a way as date sequences and continuity are reasonable.

B. Values are within permitted value domain lists, numerical range, and appropriate units.

C. Data are compliant with the data model.

D. Data are free of Personally Identifiable Information (PII)/Protected Health Information

(PHI) as required by the project.

7. Protection of Human Subjects Related to Receipt of Data. The Contractor shall be the custodian of data received from patients enrolled as research subjects in IRB approved protocols at tissue source sites (TSS). The Contractor shall establish all the necessary policies, systems, and technologies to ensure patient protection as specified by regulation (e.g., HIPAA and the Common Rule) and by NIH policies are met.

8. The Contractor shall obtain an NIH Certificate of Confidentiality to cover itself, the TSS providing data and samples to the NCI characterization network, and the other entities in the NCI characterization network.

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9. The Contractor’s electronic informatics systems shall support collection, management and distribution of all data described in this SOW, including, but not limited to, case specific clinical data and associated QC data. The informatics component of the Contractor shall interact with the Center for Cancer Genomics (CCG) Program Office, NCI COR, NCI CBIIT, CCG Biospecimen Processing Center (BPC), CCG Genomics Data Analysis Network (GDAN), and the CCG Genomics Data Commons (GDC) as necessary to ensure that data are conformant and available to CCG project requirements, appropriately accessible and can be integrated with the molecular profiling data.

Task Area 9 – EVALUATION OF NCI DATA AND PROJECTS

The Contractor shall provide support in conducting evaluations and program reviews of NCI studies, programs, projects and data. Evaluations of both the process and outcomes shall be required. Tasks may include evaluating the potential of existing data sources, performing usability testing, assisting in developing the necessary documents for OMB clearance applications, conducting portfolio analysis of existing NCI studies and assisting with preparation and obtaining regulatory documents such as NCI Special Studies IRB and Material Transfer Agreement.

Task Area 10 – TECHNICAL AND ADMINISTRATIVE SUPPORT

The Contractor shall provide technical and administrative support for NCI Meetings, conferences and workshops which shall include scheduling, arranging for transportation, lodging, meeting room facilities and teleconferencing services. It shall also include preparation and distribution of a variety of materials for meetings and teleconferences.

Task Area 11 – STATISTICAL METHODOLGY AND PROGRAMMING

SUPPORT

The Contractor shall provide support in the areas of statistical methodology and programming. This work may include population estimates of survival and prevalence, analysis of complex survey data and Joinpoint regression.