ITEB_SOW_20180125.pdf

Statement of Work – rev 20180208 Attachment 1 N02CP81000-87 Page 1 of 6

STATEMENT OF WORK

Integrative Epidemiological Studies

Independently and not as an agent of the government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the government, as needed to perform the work identified herein. Types of support to be provided by the Contractor in the conduct of studies may vary. The timeline or schedule for support activities shall be specified by the NCI Contracting Officer’s Representative (COR) based on the study. The Contractor shall inform the NCI COR of any unforeseen circumstances that may delay timely completion or progress of study activities. All study activities, documents, and procedures shall be approved by the COR prior to implementation. The Contractor shall perform some or all of the following support activities as may be specified by the NCI COR in the conduct of each study.

1. Initial Transition

The Contractor shall:

a. Safely and efficiently assume the activities from the incumbent Contractor to ensure a seamless transition without loss of time or resources, so that the transition does not pose obstacles to the conduct of ongoing services. Complete the transition within the first 30 business days following the effective date of the contract.

b. Plan and execute transition meeting(s) with the NCI COR and Contracting Officer within 5 business days following the effective date of the contract. If the NCI COR deems that one meeting is not sufficient for the transition, the COR will direct the contractor to plan and conduct additional meetings. The meeting(s) shall take place in Bethesda, Maryland with the expected attendance of the Principal Investigator and Project Manager.

c. Within 10 business days of the award, develop and implement an Initial Transition Plan, approved by the COR, including the tasks that are associated with the relocation effort from the current contractor, and the type and manner of operations required by the Contractor during the transition period. This shall include safe and effective coordination with the current Contractors at the start of the new contract period for transfer of contract-related materials. This should include all medical records, specimens (such as blood, urine, saliva, and pathology specimens), questionnaires, abstract forms, tracking records, and primary data sources for the studies conducted during the contract.

2. Study Initiation and Liaison

As indicated by the COR, the Contractor shall:

a. Determine the parties whose cooperation and approval is necessary for implementation of the study (e.g., federal or state agencies, universities, hospitals, medical offices, laboratories, other NCI Contractors, etc.).

b. Arrange for communication and meetings between the NCI research investigators and agents for those parties whose cooperation or approval is needed.

c. Attend such meetings, provide background information required, and take appropriate action on recommendations as applicable. Document proceedings and action items as requested by the NCI

COR.

d. Plan the method of identification of study subjects and make recommendations on the feasibility of alternative sampling designs. Typical study subjects include:

i. All members of families in which several members have a particular tumor or condition of interest identified by the investigators.

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ii. All patients with a newly-diagnosed cancer of a designated type or with a specific medical condition occurring in a particular group of hospitals or clinics.

iii. Patients diagnosed with designated control diagnoses or exposures occurring in designated hospitals or clinics, sometimes matched on age, sex, race, diagnosis date or other characteristics.

iv. All patients with a newly diagnosed cancer or tumor of a designated type occurring in a defined geographic area (population-based ascertainment).

v. A random sample, usually stratified on age and other demographic characteristics, of the general population living in a defined geographic area.

vi. Groups of individuals with a particular specified medical condition or treatment or other exposures.

vii. Patients treated for an initial cancer who are being followed for the occurrence of second cancers.

viii. Volunteers for participation in pilot investigations for evaluation of methodologic issues.

ix. Volunteers from specified groups to participate in etiologic research.

3. Preparation of Study Materials and Procedures

a. Prepare, pretest, and produce data collection forms (e.g., abstract forms, follow-up forms, coding forms, questionnaires and exposure assessment forms).

b. Prepare training programs and materials. Conduct training for new staff in a timely manner and update training for all staff as needed, but not less than annually.

c. Prepare procedure manuals for nurses, research assistants, abstractors, coders, interviewers, tracers, supervisors, data editors, and other personnel as needed.

d. Prepare procedure manuals for the collection of biological specimens, shipment of biological specimens, submission of specimens to repositories, and tracking of specimens and laboratory results.

e. Prepare manuals for obtaining and handling medical records, pathology specimens and reports, submission of pathology specimens for review, and collection of death certificates or cause of death.

f. Prepare and update manuals of usual operating procedures in evaluating high risk families.

g. Contribute to preparation of newsletters and brochures for informing participants of study findings and eligibility.

h. Prepare large mailings for family members or other study subjects participating in ongoing studies.

i. Assist in the preparation of study-specific packages for OMB, IRB, and/or OHSR reviews.

4. Subject Identification, Selection, and Tracing

a. Identify study subjects who meet NCI criteria for being included in studies, particularly women, minorities, and children, as appropriate. This includes methods of selecting controls from the general population and from hospitals or clinics.

b. Trace study subjects and locate them or their next of kin for interview or examination.

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5. Interview and Abstracting Data Collection

a. Obtain the necessary permissions and/or consents and then interview subjects or their family members or other proxies using mail, telephone, or in-person questionnaires. Computer assisted interviews may be necessary, depending on the study. Verify a sample (determined with the NCI COR) of completed questionnaires. Questionnaire content shall be provided by the NCI COR and shall be jointly modified, if necessary.

b. Obtain, curate and manage medical record information from Electronic Medical Records or paper forms including pathology review. Code data for entry into electronic systems (including

FAIR/FAIRVIEW).

c. Abstract and photocopy records (clinic or office medical records, hospital charts, vital records, job records, etc.). Maintain quality control over the abstracting or copying process. Verify the accuracy of an appropriately sized sample of abstracts (determined by the NCI COR) through independent reabstracting. Accuracy is to be maintained at a 98% level.

d. Procure death certificates from state vital records departments as directed by the COR. The Contractor shall be responsible for determining details of and payment for death certificate procurement from each state. The Contractor shall also be responsible for complying with state requirements regarding retention of such records in consultation with the COR.

e. Purchase other data, materials, and/or services as necessary.

f. Validate exposure or disease histories obtained in interviews by obtaining copies of original records.

g. Obtain copies of imaging studies, radiographs, or other clinical tests (e.g. electrocardiograms) and the associated reports as needed for specific studies.

h. Perform linkages such as National Death Index for vital status, cancer status, medical history, census tract residence, etc. Obtain approvals to link data with state and national registries. Linking shall be done using a quality controlled method that has gone through rigorous testing. Linking shall be able to handle partial and fuzzy data.

6. Specimen Collection, Processing, and Shipment

a. Collect and deliver biologic specimens (e.g. blood, urine, tumor,…) in appropriate shipping containers and under appropriate shipping conditions with necessary documentation to designated laboratories or investigators for storage and/or analysis as directed by the COR. This includes transport of biologic specimens from international studies with necessary customs clearances.

Verify safe arrival of specimens to the destination.

b. Obtain original pathology slides and blocks with associated pathology reports, maintain up to date inventory of requested, received, and dispersed slides and tissue blocks.

c. Arrange for specimen storage and/or standard laboratory tests or assays on biologic specimens (in one or several laboratories or repositories), as designated by the COR.

d. Perform other support activities involving specimen collection, storage, tracking and/or dispersal to laboratories as requested by the COR.

e. Report to the appropriate COR or Alternate COR all irregularities, delays, losses, deteriorations, unplanned defrostings, accidents, mishandlings, errors, discrepancies, and inefficiencies connected with any specimen collection, handling, delivery, storage, or testing activity as soon as it becomes known to the Contractor.

f. Obtain all necessary laboratory reports of results or progress.

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7. Data Preparation

a. Develop or select disease, occupation, industry, demographic, geographic, and exposure coding schemes in consultation with the NCI COR.

b. Develop and update family pedigrees in family-based studies.

c. Code information into computer readable form. Verify a 10 percent (or higher as requested by COR) sample for accuracy of the coding by independent recoding. Accuracy is to be maintained at 98% level.

8. Computer Programming and Data Processing

a. Use modifiable data management and tracking systems that can be applied across studies.

Minimize creation of unique study-specific management and tracking systems. Such systems shall be approved by the COR. Systems should be compatible with existing systems, such as Biospecimen Inventory II, Laboratory Information Management System of the Core Genotyping Facility, FAIR/FAIRVIEW or others as appropriate and specified by the COR.

b. Provide capability of creating large datasets in SAS, STATA, or other programs as requested by the COR. All data processing, storage, and transfer shall be in compliance with US Government standards of privacy and confidentiality.

c. Maintain adequate backup of study data and secure storage of backup media. Frequency of backup may vary by specific study, but shall be determined by COR.

d. Use the FAIR/FAIRVIEW for the maintenance of family studies data.

Note: FAIR/FAIRVIEW is a proprietary relational database software package developed for use by DCEG investigators. The Government shall provide the FAIR/FAIRVIEW software and training for its use to the Contractor. The Contractor shall provide the appropriate personal computers and time for training of personnel to use

FAIR/FAIRVIEW.

e. Enter coded information into suitable computer devices. Verify entry by 100 percent rekeying and other Q/C measures. Evidence that double keying was not performed shall be considered poor performance by the Contractor and shall be reflected in performance evaluations.

f. Prepare edit programs, edit data, and correct computer files where necessary.

g. Update files with follow-up data, error corrections, and other edits or changes as directed by the

h. Prepare datasets suitable for analyses for transfer to computing platforms, as specified by the

i. Provide and maintain electronic system to allow investigators with role-based permission for data access, including but not limited to data queries, data access, data submissions, and data deliveries.

In addition, it is anticipated that the program, study and project management IT infrastructure for DCEG shall evolve over the contract Period of Performance. The business process requirements for the contractor may include the use of and integration with, government provided information systems to request, track and report discrete work efforts. The contractor is expected to adopt a flexible and agile posture in its management, distribution and analysis of data to facilitate the continual improvement of the DCEG business processes.

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9. Study Monitoring, Quality Control, and Reporting

Quality control of all aspects of data collection and management is a crucial activity. NCI shall carefully review studies to ensure that the data are sound. At the beginning of each study, the NCI investigator who is responsible for the study shall approve a plan prepared by the Contractor’s study manager for the schedule and contents of reports needed for quality control. Quality controls shall require that the Contractor:

a. Document each step in a specific study and maintain, in an orderly arrangement, all relevant material so that any aspect of a study may be reviewed and evaluated by the NCI COR at any point in time. Involved are the following:

i. Type letters and prepare forms and other documents necessary in the conduct of a study.

ii. Duplicate study documents when the original sources cannot be retained.

iii. Maintain a filing system of all materials relevant to a particular study, cross referenced in a manner so as to make all of the material easily accessible. These materials shall be maintained under security in accordance with requirements of the Privacy Act as it applies to Contractors. Data for family studies shall be maintained in accordance with requirements of a Certificate of Confidentiality.

iv. Maintain a log of decisions made during each study that affect the design, conduct, or analysis. Each entry shall include a brief explanation and date of the problem, the decision made, and the name of the NCI staff member who authorized the change.

b. Develop and use internal record-keeping procedures for assessing the progress and status of data collection, preparation and entry. These record systems may be paper files or computer systems.

c. Monitor and document the performance and progress of any work done under subcontract in the performance of a study.

d. Develop quality control procedures for the handling of biologic specimens specific for needs of each study.

e. Report verification rates, discrepancy rates, and error rates for data collection, preparation and keying following the schedule agreed upon with the COR. Any unusual problems shall be brought immediately to the attention of the COR.

f. Provide monthly, semi-annual, and final technical progress reports and monthly budget reports, as specified by the NCI COR and/or designated representative.

g. Provide and maintain electronic system to allow investigators with role-based permission for various study monitoring, quality control and reporting activities, including but not limited to initiate and track requests and other communications, monitor billing, track project status. In addition, it is anticipated that the business and financial tracking and reporting requirements shall evolve over the contract Period of Performance. These requirements for the contractor may include the use of and integration with government provided information systems to request, track and report discrete work efforts. The contractor is expected to adopt a flexible and agile posture in its project management efforts in order to facilitate the continual improvement efforts of the

DCEG.

10. Final Transition:

The Contractor shall submit a Final Transition Plan to the NCI COR during the final year of the contract. At a minimum the plan must address how information will be successfully transitioned to a subsequent contractor. A draft of this transition plan is due to the NCI COR 120 calendar days prior to the completion date of the contract. The final plan is due at least 90 calendar days prior to the completion date of the contract for final review and approval by the NCI COR.

The transition plan shall include recommended steps to sustain the routine daily activities to minimize any disruption of the contract activities during the transition. All required activities

N02CP81000-87 Page 6 of 6 shall be maintained at a level specified by the COR including the tasks that are associated with the relocation effort to the NCI designee. In addition, inventory of all data collection instruments developed during the contract, all raw data, and all deliverables to the Government shall be completed. All study related materials, documentation, and archived records shall be transferred to the NCI designee prior to the end of the contract. The transition plan should include detailed descriptions of the security measures for protecting the privacy and confidentiality of the clinical and other records and data collected during the contract.