Attachment3StatementofWork082113.pdf

Attachment 3: Statement of Work Page 1 of 10 RFP Number: N02CN35003-43 August 22, 2013

Cancer Prevention Clinical Trials Auditing and Informatics Support

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, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work.

Scope:

The Contractor shall provide integrated, comprehensive clinical trial oversight capability for the National Cancer Institute (NCI), Division of Cancer Prevention (DCP) cancer prevention clinical trials program by providing services required to perform the following tasks:

Transition Tasks: Provide services to coordinate and integrate transition tasks.

Task Area 1: Provide an instance of Oracle® Clinical-Remote Data Capture (OC-RDC) and the services for the data management of designated cancer prevention clinical trials and the development, maintenance and integration of data transfer and reporting mechanisms for data collected from cancer prevention clinical trials.

Task Area 2: Provide auditing and data verification services for cancer prevention clinical trials.

Task Area 3: Provide education and training services to staff conducting cancer prevention clinical trials.

The services provided in Task Area 2 and Task Area 3 support the primary objectives of this contract.

Data Management

The scope of the studies for which a clinical data management system and services are required include designated studies in DCP’s clinical trials program, including studies funded under the 2003 consortia mechanism, that are managed in Oracle® Clinical-Remote Data Capture (OC-

RDC).

Auditing and Data Verification

The scope of studies to be audited includes Phase 0-I-II DCP cancer prevention clinical trials where DCP is the study sponsor, Investigational New Drug (IND) sponsor or the agent supplier.

Those Phase III trials for which DCP is the IND sponsor and/or agent supplier may also be audited as directed by DCP. The scope includes, but may not be limited to, studies funded under the 2003 and 2012 consortia mechanisms. The scope does not include those cancer prevention trials sponsored by the Community Clinical Oncology Program (CCOP), and/or performed through the NCI Cooperative Group mechanism.

Education and Training

The scope of the education and training services includes, but may not be limited to, the development and presentation of programs, resources and materials needed to support study site staff conducting DCP-sponsored studies funded under the 2003 and 2012 consortia mechanisms.

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The service capabilities for Task Areas 1 through 3 shall be flexible and adaptable to accommodate evolving requirements for NCI and DCP clinical trials management and reporting of studies funded under the 2003 or 2012 consortia mechanism and studies for which DCP is the study sponsor, Investigational New Drug (IND) sponsor or the agent supplier.

Objectives:

The primary objectives of this contract are to:

provide auditing and data verification services in order to ensure site compliance with DCP’s protocol, regulatory, pharmacy and data collection requirements, and provide education and training services regarding the conduct of DCP studies to staff at clinical sites.

Other objectives of this contract are to:

provide a clinical data management system, including OC-RDC and its infrastructure, and services for the on-going development and maintenance of the DCP data capture systems including the mechanisms used to enter, report and/or store study data, and provide services that support selected programs/applications in the DCP central database.

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For all Task Areas, the Contractor shall:

1. Create and maintain a Manual of Operating Procedures (MOP) for the conduct of the Task Order Statement of Work.

2. Provide project management services to coordinate and integrate all Task Areas. These services shall include providing all deliverables and management-related services necessary to perform the work associated with each task order.

The Contractor shall perform work in the following Task Areas as outlined in each Task Order.

TRANSITION TASKS

The Contractor shall provide services to coordinate and integrate transition tasks.

1. Provide a Transition-in Plan, if required, for the coordination and implementation of the orderly, secure and efficient transition of all activities, materials, data and other documents from their predecessor.

1.1 The Plan will describe the Contractor’s strategy for the transition of work from the incumbent Contractor to ensure continuity of services, and must include plans for provision of key personnel; transfer of relevant files, records, and materials to a secure server or storage space; and the transition of all activities.

2. Establish a Transition-Out Plan, if required, for the transfer of contractual activities and products to a successor contract in conjunction with the COR. The Transition-Out Plan shall be completed 60 days prior to the expiration of the contract. During the transition period, the Contractor shall turn over contract material, files, documents, and any other holding to any organization or group selected by NCI/DCP as well as provide continuity of service during the transition period. The Contractor shall provide any other assistance deemed reasonable by NCI/DCP that may be required for the smooth transition of contract responsibility.

TASK AREA 1: Data Management, Data Transfer and Reporting

The Contractor shall provide data management services, through study completion and final database lock, for those studies in DCP’s clinical trials program that are managed in Oracle® Clinical-Remote Data Capture (OC-RDC). The Contractor shall supply and host the OC-RDC system and those services required to support the development, maintenance and/or integration of data transfer, reporting, and storage mechanisms for designated DCP cancer prevention clinical trials

A. Data Management

The Contractor shall:

1. Provide services required to host and maintain the clinical trials data management system (OC-RDC V4.6 or later) that receives clinical trials data for designated DCP studies and is

Attachment 3: Statement of Work Page 4 of 10 compatible with DCP’s central database, the DCP Enterprise System Knowledgebase (DESK), and other DCP enterprise applications for the routine exchange of data.

1.1 In the event that the Contracting Officer’s Representative (COR) determines a new informatics system (either a custom-built or commercial off-the-shelf [COTS] solution) or new instance of OC-RDC is needed during this contract, the Contractor shall provide a transition plan which describes the testing procedures and validation according to Capability Maturity Model Integration (CMMI) level 3 or equivalent requirements.

1.1.1 New informatics systems developed by the Contractor under this contract shall be compatible with OC-RDC, DESK and applicable NCI standards and initiatives.

1.1.2 The Contractor will provide services required to maintain the new informatics system.

2. Use standards adopted by the National Cancer Informatics Program (NCIP) that promote semantic and syntactic interoperability and compatibility among data and systems, and ensure compliance with all applicable standards for data and systems integrity, confidentiality and security. (http://cbiit.nci.nih.gov/ncip )

3. Ensure support for the interoperability of data between the clinical trials database (OC-RDC) and any system implemented as a DCP- or NCI-wide application for clinical data management and/or reporting.

4. Use the clinical trials database (OC-RDC) and DESK to provide services to support and maintain the systems for submission and reporting of clinical trials data for designated DCP studies, and to do the following:

4.1 Provide routine and Ad Hoc reports from data in OC-RDC and/or DESK for use in the conduct of quality, timeliness and completeness reviews of entered and/or reported data,

4.2 Provide quality assurance reviews of data in the clinical trials database and assist in the resolution of data discrepancies,

4.3 Transfer OC-RDC data into DESK two times a month for use in clinical trials auditing and other related activities,

4.4 Develop and/or maintain Ad Hoc reports to present pertinent clinical trial information to DCP and other users specified by the COR,

4.5 Provide metrics for use in assessing the performance of designated study sites, including measures of data quality and timeliness of data submissions.

4.6 Provide data management services and resources for the conduct of designated DCP clinical trials including but not limited to educational materials specific to OC-RDC processes and Helpdesk support.

5. Be in compliance with federal requirements for retaining all participant and study data for a period specified by federal regulations after the termination of an IND, after the approval of a New Drug Application (NDA) or Product Licensing Application (PLA), or when an IND is not filed (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&sho wFR=1&subpartNode=21:5.0.1.1.3.4).

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5.1 Only upon written approval by the DCP COR may records be destroyed or deleted from OC-RDC or other electronic data management system used for DCP-sponsored studies.

B. Data Transfer and Reporting

1. Provide services for the development, maintenance and/or integration of the systems and mechanisms for the transfer, reporting and archiving or storage of clinical data, datasets, reports and/or study-specific documents generated from designated DCP cancer prevention trials.

1.1 Systems used in performing the services required for this acquisition should be compatible with those systems and applications supporting the DCP’s clinical trials program, including communication among the staff participating in this program and reporting of clinical trials data using SAS®-based reports and datasets.

Compatibility should be assured with Oracle® Clinical-Remote Data Capture (OC- RDC v4.6) and Oracle® 10G for data and document management in DCP’s clinical database (OC-RDC), central database (DESK), and Collaboration Repository (DCPCR). In addition, compatibility is required with both PC and MAC operating systems and products, including Windows XP, MAC 10.8 and the MS Office Suite including Outlook, utilized by DCP staff.

2. Provide services for the development and/or maintenance of systems and applications that provide routine and Ad Hoc correspondence, reports, and datasets from data and information in OC-RDC and/or DESK for use in DCP data management, protocol and clinical trial management and/or regulatory activities.

2.1 The Contractor shall provide monthly DESK Management Reports (as specified by the COR) in support of DHHS methodology for measuring cost and schedule performance.

2.2 The Contractor shall create and post monthly study-specific SAS datasets of OC-RDC data to a secure clinical data transfer (CDT) website.

2.2.1 The Contractor shall supply and host the CDT to provide a secure method for OC-RDC users to access and download study-specific datasets and reports, and documentation and/or updates regarding the Consortia clinical trials data.

3. Provide services for the continued maintenance and enhancement of the data transfer mechanisms for the routine receipt and reporting of data from designated cancer prevention trials managed in OC-RDC. These mechanisms shall support:

a. the automated secure transfer and receipt of participant data files from lead and participating organizations for electronic loading into OC-RDC, and

b. the secure and accurate transfer of participant data from the clinical trials data base (OC-RDC) to the DCP central database (DESK) and designated Center for Biomedical Informatics and Information Technology (CBIIT) systems and applications.

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4. Provide services for the continued maintenance and enhancement of the DCP Collaboration Repository (DCPCR), the central repository of clinical datasets, technical documentation, administrative files, and regulatory documents.

4.1 The Contractor shall maintain current technical and user documentation for the DCPCR and its content areas.

4.2 The Contractor shall provide services for the secure transfer of study-specific datasets, reports and documentation from the CDT and/or other systems to the DCPCR for archiving or storage.

5. Provide services for the development and/or maintenance of systems (which include but are not limited to reporting mechanisms, databases or applications) as required by DCP to support protocol management, clinical trial and data management, and regulatory activities.

5.1 The Contractor shall:

Employ industry standard processes to gather requirements, design and develop and maintain IT systems.

Utilize, re-use, and enhance existing software unless justification has been provided that such design is determined by DCP to not be in their best interest.

Provide service for integration with other systems as needed.

Implement systems in compliance with federal regulations and security requirements

6. Create and/or update Technical Documentation for any system developed and/or maintained by the Contractor. Documentation should include as appropriate the data model, entity relationships, valid values, definitions and business rules. The documents shall be updated as appropriate to address changes to these systems.

7. Provide services to maintain reliable systems and operations capability.

7.1 The Contractor shall assure that all DCP electronic operations systems are backed up routinely. The COR will identify the back-up priority for each application based on the criticality of the system data. The Contractor shall assure:

High-critical data is backed-up hourly

Mid-critical data is backed up daily

Low-critical data is backed up twice a week

Back-up tapes shall be stored and rotated to maximize data integrity, safety and minimize system downtime. All data tapes are to be stored in a secure fire-resistant facility.

7.2 The Contractor shall have a process developed to minimize the risk of data loss and disruption of operations. Regular maintenance procedures that impact resources shall be performed during nights or weekends.

7.3 All systems shall be fully functional 7 days a week. System update (including patches)/maintenance shall be performed at nights and/or weekends to minimize the risk of data loss and disruption of operations.

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7.4 In the event of a major natural disaster (i.e. weather, earthquake, etc.) or man-made disaster (i.e., power outage, etc.) causing a shutdown of DCP operations, the Contractor shall ensure that all systems developed to collect and report participant level data shall be fully operational within 24 hours.

TASK AREA 2: Auditing and Data Verification

The Contractor shall provide auditing and data verification services for designated DCP cancer prevention clinical trials to ensure site compliance with DCP’s protocol, regulatory, pharmacy and data collection requirements.

A. General requirements:

The Contractor shall:

1. Conduct all audit and data verification visits as described in each Task Order and documented in the Manual of Procedures (MOP). At a minimum, the Contractor shall develop or update the MOP to:

1.1 Outline the procedures for conducting annual audit visits, interim visits and close-out visits including requirements for regulatory review, data verification, drug accountability, and procedural compliance.

1.2 Describe the points to be discussed with the Study Principal Investigator, site staff and DCP staff during audit visit exit summary meetings.

1.3 Ensure the privacy of data in accordance with current standards for data confidentiality.

(http://privacyruleandresearch.nih.gov/pr_02.asp and www.hhs.gov/foia/privacy/index.html)

Under no circumstances shall any records in which participants may be identified be removed by the Contractor from an organization. Participant records shall be treated as confidential material. If copies of source documents are requested, all personal identifiers shall be removed from these documents by the clinical trial site prior to submission.

2. Visit each DCP-contracted clinical trial site, at least once per year or as determined by the COR, to conduct an annual audit visit, interim visit or close-out visit to:

2.1 Perform on-site audits and data verification during the conduct of DCP-sponsored study or studies at designated organizations to confirm subject eligibility, data accuracy and completeness, compliance with protocol, pharmacy, and regulatory requirements, and all applicable government regulations.

2.1.1 Selected study records from each clinical trial conducted at Participating Organizations (POs) shall also be audited.

2.2 Ensure studies are conducted, recorded and reported in accordance with the Division of Cancer Prevention’s (DCP) protocol, regulatory, pharmacy, and data collection requirements. (http://prevention.cancer.gov/programs-resources/programs/phase-0-I-

II)

2.2.1 Document discrepancies as required. The Contractor shall monitor resolution of these discrepancies until resolution and assist the clinical sites in the resolution as required.

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2.3. Ensure adherence of each Consortia Lead Organization (CLO) to the appropriate DCP Consortia Standard Operating Procedures (SOPs), and ensure that all audit visits by the CLO are conducted uniformly and consistently across sites.

(http://prevention.cancer.gov/programs-resources/programs/phase-0-I-II)

2.4 Perform verification of participant data submitted to DCP.

2.4.1 For data submitted via OC-RDC, the Contractor shall verify the information recorded in the study Case Report Forms (CRFs) against the same data in OC- RDC and the participant’s source documentation to ensure accuracy, completeness, and consistency between the participant’s source documentation and OC-RDC.

2.4.2 For data submitted via the Minimum Data Set, the Contractor shall verify these data against the same data in the CLO’s study database of record and against the participant’s source documentation to ensure consistency between the CLO’s study database and DESK.

3. The Contractor shall develop the requirements and process for off-site data verification of the MDS quarterly and at completion of each Consortia study.

4. Develop and/or maintain current systems and reports for tracking site auditing visits and results The Contractor shall provide a Site Visit Report Template to document the activities and outcomes of site visits.

B. Scheduling and Conducting Initiation Visits:

1. On an Ad Hoc basis, work with the CLO or clinical trial site to coordinate and conduct study initiation visits.

2. Prepare and submit initiation visit reports to DCP for review within 15 business days of the visit.

C. Audit and Data Verification Visits:

1. Develop and maintain a process for scheduling audit visits, notifying organizations and DCP of scheduled visits, sending written reports of the audit visit(s) electronically to the CLO and DCP, notifying organizations of required post-audit visit action items if any, and tracking the organization’s response to action items until all items are resolved.

2. Schedule audit visits so that an organization conducting several DCP studies is not required to undergo multiple audit visits during a single year. The Contractor shall develop procedures and logistics for conducting consolidated site visits in order to maximize efficiency and minimize costs.

3. Notify all organizations, the COR, and DCP staff a minimum of six (6) weeks in advance of a scheduled audit visit date.

3.1 Provide DCP staff and lead organizations with a list of protocols and data records to be audited at least four (4) weeks before the scheduled visit date.

4. Audit each CLO or clinical trial site at least once a year or as determined by the COR during the conduct of a study/or studies. The Contractor audit visits shall include but not be limited to the following activities:

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4.1 Verify that all required regulatory documents have been submitted to the DCP Regulatory Support Contractor and are present in the site’s regulatory binder.

4.2 Randomly sample 25% or a minimum of 7 charts (whichever is greater) of participants randomized or registered (for non-randomized studies) per study per accruing organization for data verification and protocol compliance, including but not limited to verification of participant eligibility and endpoint data collection according to protocol:

4.2.1 If an eligibility violation is noted in one or more charts, 2 additional charts will be reviewed for eligibility verification. If either or both of these 2 charts are found to have an eligibility violation, the monitor will notify the DCP Medical Monitor via phone to determine if additional charts should be examined.

4.2.2 If the audit of randomly sampled charts reveals that for one or more participants, end point data was not collected according to protocol, 2 additional charts will be reviewed for endpoint data verification. If end point data has not been collected according to protocol in either one or both of these 2 charts, the monitor will notify the DCP Medical Monitor via phone to determine if additional charts should be examined.

4.2.3 One unannounced chart will be audited during each visit.

4.3. As part of the audit visit, the Contractor shall also audit selected study records from each Consortia study conducted at Participating Organizations. These PO study records will be selected from those charts that have been previously audited by the Consortia Lead Organization (CLO) Site Coordinator or designee.

4.4 Notify the DCP Medical Monitor and DCP Task Area 2 Manager during the audit visit if one or more major deficiencies are identified.

4.5 Audit 100% of participant records for the presence of an IRB approved, signed and dated current Informed Consent form, including verification that the informed consent was obtained appropriately, and prior to any study-specific procedures.

4.6 Verify eligibility assessment and endpoint and/or response assessment for 100% of all participants.

4.7 Conduct a pharmacy audit including a review of procedures for documenting appropriate accountability and administration of the investigational product (e.g., ensuring the integrity of randomization at the site level and maintaining the study blind, where appropriate).

4.8 Conduct Specimen Inventory Tracking, including a review of source documentation for the collection and tracking of specimens for eligibility and endpoint assessments.

5. Perform interim audit visits when there are significant irregularities or issues identified.

Interim visits shall be scheduled by the Contractor at the request of the COR.

6. Prepare a preliminary report of the annual or interim data audit visit, and send the report electronically to the COR(s) and appropriate DCP Medical and/or Scientific Monitor and DCP Nurse Consultant, within two business days of completing the visit. The final audit visit report shall be sent to the COR(s) and appropriate DCP Medical and/or Scientific Monitor and DCP Nurse Consultant within 15 business days of the visit, and to the CLO within 4 to 6 weeks of the site visit

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6.1 The COR(s) and Medical and/or Scientific Monitor must be notified immediately by telephone of any findings suggestive of intentional misrepresentation of data and/or disregard for regulatory safeguards for any of the components of the visit.

TASK AREA 3: Education and Training

To support DCP in fulfilling its auditing and data verification responsibility, the Contractor shall provide ongoing education and training services for study site staff conducting DCP-sponsored studies.

1. Address clinical trial site staff educational needs based on input and/or requests from DCP.

The Contractor shall develop an education plan, based on the identified need(s), as requested, and submit all proposed educational plans to the COR as directed for review and approval prior to implementation. DCP may request Ad Hoc educational program(s) for study site staff to address changing government needs and/or requirements.

2. Provide educational materials and programs for routine use by the DCP-sponsored cancer prevention clinical trial staff. These educational materials and programs include, but are not limited, to the HelpDesk, Remote Data Capture (OC-RDC) training as required, Recruitment and Retention guidelines, and DCP Consortia Standard Operating Procedures (SOPs)..

2.1 The Contractor shall develop and maintain the SOPs to support the work of the Consortia 2003 and Consortia 2012 clinical sites and staff. The SOPs will be updated as requested by DCP.

2.2 The Contractor shall develop and maintain a Helpdesk during the hours of 8 a.m. to 6 p.m. Eastern Standard Time (EST) for the Consortia 2003 and Consortia 2012 clinical sites and staff to address questions and issues regarding OC-RDC, auditing and/or general administrative issues.

3. Conduct educational sessions for clinical trial site staff using teleconferences, Webinars and other remote conferencing methods as appropriate. Use of print materials shall be kept to a minimum.

4. Review the content of the DCP consortia clinical trials webpage(s) annually (http://prevention.cancer.gov/clinicaltrials/management/consortia). Provide a concise Clinical Trials Resource Report of the review findings and recommendations for webpage modifications to the COR.

4.1 Maintain and/or update the content of the existing DCP consortia clinical trials webpage in collaboration with DCP staff and DCP’s regulatory and IT support contractors. All proposed updates to the DCP consortia clinical trials webpage will require the approval of DCP.

4.2 Coordinate with DCP staff and IT and website support contractors as required to identify, develop and/or implement webpage modifications and/or enhancements

5. Provide support at the annual DCP Site Coordinators’ Meeting which may include, but not be limited to, a poster session, roundtable discussion, and podium presentation.