75N91020R00042 - Attachments.pdf

ATTACHMENT 1 PACKAGING AND DELIVERY OF PROPOSAL

75N91020R00042 Page 1 of 2

Attachment 1 - Packaging and Delivery of Proposals for Use with the NIH electronic Contract Proposal Submission (eCPS) Website

I. PROPOSAL SUBMISSION

A. eCPS

1. Proposals must be submitted via the electronic Contract Proposal Submission (eCPS) website at https://ecps.nih.gov.

2. Proposals submitted by facsimile or e-mail will not be accepted.

3. Follow the “How to Submit an Electronic Proposal” instructions provided on the eCPS website at: https://ecps.nih.gov/home/howto. Please note that creating an account to submit may take up to three (3) business days. Please apply for a new account early to allow enough time for the registration process.

4. Offerors are solely responsible for submitting proposals and any modifications or revisions so as to reach the Government office designated above by the date and time specified in the solicitation.

B. Creating and Naming Files:

1. Create one PDF file of your Technical Proposal, including all attachments. The

Technical Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Technical Proposal PDF file.

2. Create one PDF file of your Business Proposal, including all attachments:

The Business Proposal should be created in a PDF format that enables word searches to the maximum extent practicable. Forms and/or documents requiring signature(s) may be scanned, but must be merged into the Business Proposal PDF file.

Additionally, the “Breakdown of Proposed Estimated Costs (plus Fee) with Excel

Spreadsheet” (http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) must be included in the Business Proposal.

3. Create your Business Document Excel. The Excel file should be the “Breakdown of

Proposed Estimated Costs (plus Fee) with Excel Spreadsheet”

(http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx) included in the Business Proposal in its original Excel format, not PDF. Multiple Excel files may be included, as necessary.

4. Each of the proposals, Technical and Business, must be separate and complete in itself.

Do not reference one proposal in another.

https://ecps.nih.gov/ https://ecps.nih.gov/home/howto http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx http://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/spshexcl_dec2012.xlsx

ATTACHMENT 1 PACKAGING AND DELIVERY OF PROPOSAL

75N91019R00042 Page 2 of 2

5. File naming convention: It is requested that the filenames for your Technical Proposal, Business Proposal, and Excel Workbook include the name of the offeror, the solicitation number and the type of proposal (i.e., Technical, Business, or Excel Workbook).

Examples:

Technical Proposal: XYZ Company_NIHAI2012001_Technical.pdf

Business Proposal: XYZ Company_NIHAI2012001_Business.pdf

Excel Workbook: XYZ Company_NIHAI2012001_Business.xlsx

II. FORMATTING AND PAGE LIMITATIONS:

A. Formatting for proposals

1. Proposal page layout shall be letter size 8.5” x 11" for all pages.

2. Proposals shall not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information.

3. Proposals shall not include audio or video files of any type.

4. Font size must be 10 to 12 points.

5. Spacing should be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text.

6. Margins must be at least one-inch on all sides.

7. Failure to adhere to the formatting requirements above may impact whether your proposal is reviewed in its entirety.

B. Page limitations:

1. The total page count of the Technical proposal shall not exceed 35 pages.

2. Total page count does not include:

a. Title and Back Page; Table of Contents; Section Dividers that do not contain information other than title of Section; and

b. The Human Subject and Clinical Trial Information Form, if required by the solicitation.

3. Each Curriculum Vitae (CV) shall not exceed 6 pages.

4. Pages exceeding limitations will be removed from the proposal and will not be considered.

PROPOSAL INTENT RESPONSE FORM

RFP No:

RFP Title:

Please review the Request for Proposal (RFP). Furnish the information requested below and return this page to the Contracting Officer/Contract Specialist identified on Section A-Solicitation/Contract Form by

Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

Choose one of the following Options:

Do intend to submit a proposal Do Not intend to submit a proposal

If you are not responding to this RFP, please provide your reason(s):

Please provide the following contact information:

Name (First, Middle Initial, Last):

Title:

Organization:

E-mail:

75N91020R00042 Attachment 2

Attachment 3 – Statement of Work Page 1 October 9, 2020

STATEMENT OF WORK

Independently and not as an agent of the Government, the contractor shall furnish all the necessary services not otherwise provided by the Government as needed to perform the Statement of Work below.

Scope of Work

The purpose of the Protocol Information Office (PIO) support contract is to:

• Utilize various databases and document tracking/reviewing of applications to electronically track a protocol throughout its lifecycle.

• Abstract key information including data elements, milestones and treatment descriptors into the Cancer Therapy Evaluation Program Clinical Oncology Research Enterprise (CTEP CORE) database to facilitate informed and timely Program decision-making.

• Support of protocol related materials and CTEP study related meetings.

• Assist CTEP with the tracking of Operational Efficiency Working Group (OEWG) timelines.

• Store electronic materials and document Standard Operating Procedures (SOP).

Specific Tasks

Task 1 – Utilize various databases and document tracking/reviewing of applications to electronically track a protocol throughout its lifecycle.

• The Contractor shall obtain the necessary email accounts, usernames and passwords needed to access all relevant IT systems, including but not limited to, NIH email (Outlook), network folders, SharePoint site and CTEP CORE applications.

• The Contractor shall abstract information from protocol-related documents (including, but not limited to, Project Team Member Applications (PTMAs), Letters of Intent (LOIs), Concepts, new protocols, protocol revisions or amendments) received for all CTEP-sponsored trials as well as a subset of trials sponsored by other Institutes, Divisions or Programs. The Contractor shall utilize established Standard Operating Procedures (SOPs) and User Guides as tools to determine what information needs to be abstracted depending on the type of document received. Types of information to be abstracted include, but are not limited to, title of protocol, name and contact information of the principal investigator, treatment information, trial phase, lead organization on the trial, and discussion date by CTEP.

• The Contractor shall review all submitted documents for completeness and accuracy, in accordance with established SOPs. The Contractor shall communicate electronically with the submitter (a member of the lead protocol team or CTEP staff or contractor) to provide information on the submitted documents and to acknowledge receipt. Electronic communication is necessary to maintain documentation of protocol communication.

• The Contractor shall communicate electronically with the site regarding “incomplete submissions”, as defined by current CTEP business rules, as defined in the protocol development section of the CTEP website (see Appendix 2). For any submission deemed incomplete, the Contractor shall notify the submitter of the elements missing and ask for resubmission.

• The Contractor shall utilize a CTEP designed module to enter milestones on each protocol related record created when the milestone occurs. Milestones refer to pre-determined points in the trial development process which allow for the tracking and monitoring of activities related to the review and approval of a submission.

The Contractor shall select the appropriate milestone from a list of values in the module.

Attachment 3 – Statement of Work Page 2

• The Contractor shall create a process for performing quality control (QC) checks on abstracted information as well as the contents of the protocol folder. The Contractor shall perform all QC checks at intervals prior to the distribution of submission information and documentation to either CTEP reviewers or the submitter. The Contractor shall create QC checklists which shall be used to conduct the QC process.

Task 2 – Support of Protocol-Related Material

• Following the abstraction of a completed submission into CTEP CORE, the Contractor shall prepare an electronic protocol file for storage within NCI’s computer servers. The protocol file shall be established following established SOPs. The Contractor shall also prepare an electronic review packet for each CTEP reviewer involved in the review of a particular submission. The Contractor shall use a list developed by CTEP from which to select the appropriate reviewers.

• The Contractor shall distribute the review packets via a government provided electronic review system.

• The Contractor shall expect to receive the reviews generated by reviewers electronically. If reviewers do not submit their reviews to the Contractor on time as defined in the approved SOP, the Contractor shall issue an electronic reminder to the reviewer(s), typically 1-2 business days after the due date of the review.

• The Contractor shall review the submitted reviews for comments or information that is to be added to the submission record in CTEP CORE.

• The Contractor shall store the reviews electronically in NIH folders, on NIH servers, following established

SOPs.

• The Contractor shall include additional reviewers, committees, or process steps at the request of the COR.

• The Contractor shall issue electronic consensus review letters, follow-up review letters, decision letters, and coding letters to the submitter. The Contractor shall follow established SOPs, to determine when each letter shall be distributed. Each letter may be system-generated by the module or provided by a CTEP reviewer.

The Contractor shall review the letter for accuracy and completeness of administrative information regarding the submission. Prior to the distribution of each letter, the Contractor shall ask the CTEP reviewer to approve the letter electronically. A digital signature may also be required on the letter.

• The Contractor shall comply with current CTEP business rules that govern processes related to the regulatory requirements that CTEP is required to follow, in accordance with the established SOPs. The business rules must adhere to FDA regulations and OHRP regulations.

• The Contractor shall, with the approval of the COR, issue special mailings and notices regarding various safety, regulatory or other related information to sites conducting CTEP-sponsored trials. Special mailings include Notice to Investigators about an adverse event suffered by a patient. The Contractor will receive the special mailing from the Government with instructions defining what will be included in the mailing and to whom the mailing will be sent. The Contractor shall issue all mailings electronically. The Government will provide the Contractor with a log that the Contractor shall use to track the mailings issued. Submitters will respond to the mailings by a date specified in the mailing. For submitters that do not respond by the date specified, the Contractor shall issue an email reminding the submitter of the requirement to respond, which may include, in consultation with and approval by the COR, any actions the Government may take for failure to respond.

Task 3 – Meeting Support

Attachment 3 – Statement of Work Page 3

• The Contractor shall prepare the meeting packets for the Investigational Drug Branch (IDB), Concept Review Meeting (CRM), Biomarker Review Committee (BRC), Protocol Review Committee (PRC) meetings and other CTEP study related meetings.

• The Contractor shall prepare review packets electronically prior to the meeting as specified in the SOP. The packets shall be navigable electronically according to electronic submission requirements available on the CTEP website.

• The Contractor shall generate the preliminary and final meeting agendas. The Contractor shall distribute these agendas based on a CTEP designated schedule. Typically, preliminary agendas are sent on a Friday at least 2 weeks before the meeting, and the final agenda is sent the business day before the meeting.

• At the request of the COR, the Contractor shall include additional invitees on the agenda notifications.

• The Contractor shall send a representative to each meeting. The Contractor shall bring a laptop with connectivity to CTEP networks in order to answer any questions through access to CTEP applications and protocol-related documents, and to project the meeting packet. The Contractor shall record the decisions and comments made about each review and shall transfer the information to the module, the protocol file, or any other location or person required. The Contractor shall address or record PIO-related issues for resolution, such as requests for additional documentation to the study team. The Contractor shall attend CRM, BRC, PRC and IDB meetings to address PIO-specific issues or record PIO-related issues for follow-up at future meetings. The Contractor shall circulate OEWG conference call attendance forms to the Lead Reviewer for approved LOIs, Protocols and Concepts after the meeting.

Task 4 – Assist CTEP with the tracking of Operational Efficiency Working Group (OEWG) timelines

• The Contractor shall schedule conference calls for approved or on hold LOIs, concepts and protocols between selected CTEP staff and study team members. The Contractor shall also be asked to schedule ad hoc calls between CTEP staff and study team members, with permission from the COR.

• The Contractor shall attend the conference calls and prepare meeting minutes for the calls as established in the

SOP. The Contractor shall have the minutes available to the Lead Reviewer no later than three (3) business days after the call. The Contractor shall have the CTEP approved meeting minutes distributed to call attendees no later than one business day after final approval of the minutes by CTEP, unless otherwise directed by the COR.

• The Contractor shall track OEWG timelines for all approved LOIs, approved concepts and protocols in review and shall contact the study team as needed to receive updated documents; interface with all trial development participants including NCI and extramural professional and support staff; NCI contractors; and FDA and pharmaceutical company personnel.

• The Contractor shall prepare consensus reviews using the CTEP approved template for Protocols after PRC.

The Contractor shall send them to the Lead Reviewer for approval within 3 business days after PRC. The Contractor shall distribute the approved consensus review to the study team no later than one business day after final approval of the minutes by CTEP.

• The Contractor shall be required to prepare follow up reviews for protocols in review or amendments. The

Contractor may also be required to prepare other typing requests for CTEP staff for distribution to study teams, in consultation with the COR.

• The Contractor shall establish a project timeline for each protocol and identify/track key and appropriate sub-

Attachment 3 – Statement of Work Page 4 task milestones and responsible study development participants and their contact information (i.e. telephone, e-mail), via CTEP CORE

• The Contractor shall utilize CTEP CORE to abstract and track relevant OEWG milestones, key-words and study development participants.

• The Contractor shall collaborate with other NCI staff and contractors involved in the protocol review process

(i.e. CTSU, CIRB, CTMS) to minimize redundancy and gaps in supporting the protocol review process. It must be emphasized that the Contractor is not intended to replace, or duplicate activities currently being performed by other CTEP contractors or government staff, but rather it is intended to provide proactive coordination to assure that protocol development and implementation timelines are met. This contract is strictly for coordination of reviews and timeline management.

• The Contractor shall communicate with study development participants (i.e. scientific reviewers, support staff, study coordinators) via email, telephone, or other suitable mechanisms.

• The Contractor shall prompt and/or remind study development participants to address issues in a timely fashion as stated in the approved SOPs.

• The Contractor shall develop prompts or triggers to alert appropriate personnel (i.e. study participants, NCI/extramural site leadership) regarding any potential or actual delays.

• As needed, The Contractor shall escalate awareness of any issues that might delay trial development to the appropriate NCI and extramural site leadership.

• When approved by COR, the Contractor shall adjust/modify protocol development timelines to accommodate unforeseen delays.

• The Contractor shall recommend policies to further streamline the protocol development and amendment process. All policies must be approved by the COR before implementation.

• The Contractor shall maintain up to date electronic reports documenting current status of each protocol, which shall be a working/living document that gets updated in real-time and can be accessed via CTEP CORE by other stakeholders when they need it. The reports shall be user friendly and highlight and prioritize any potential or actual delays in protocol development. Reports shall reflect actual versus expected timelines.

Contractor shall review these reports regularly with CTEP lead investigator/reviewers and with members of CTEP’s OEWG at regular meetings.

• The Contractor shall develop metrics that align with the QASP to assess overall performance of protocol development timelines based on trial type to identify trends, bottle-necks and successes.

• The Contractor shall identify potential roadblocks or impediments to the clinical trial development process, including the protocol amendment process and recommend solutions.

• The Contractor shall identify and implement any other tasks and or processes that will facilitate and improve the protocol development process and the protocol amendment process in collaboration with NCI staff and contractors.

• The Contractor shall coordinate regular OEWG meetings, solicit agenda items from OEWG, provide updates on action items, accomplish action items and resolve issues after meeting and collaborate with members of the

Attachment 3 – Statement of Work Page 5

OEWG when needed to address issues, prepare minutes of OEWG meetings that focus on action items needed and action items completed.

Task 5 - Store electronic materials and document Standard Operating Procedures (SOP).

• The Contractor shall utilize the main PIO email address for all PIO-related correspondence. The Contractor shall use the established NCI network drives to store all protocol-related documents, as directed by the COR.

• The Contractor shall prepare and maintain an electronic protocol file that will contain all protocol-related documents for each CTEP-sponsored study.

• The Contractor shall ensure the physical security of any courtesy hard copies of files and materials given that all CTEP documents are considered confidential. This includes but is not limited to, prevention of unauthorized entry, theft, misuse, or damage to files and Government materials. Computers must be signed off and hard copies locked in cabinets when personnel are away from their desk.

Additional Requirements

Documentation

• The Contractor shall have in place a set of Standard Operating Procedures (SOPs) to describe the process for completing the tasks required by the SOW. The COR will be provided the opportunity to review and comment on the SOPs before the procedures are implemented. The SOPs shall be developed within 90 calendar days after the effective date of the contract. The Contractor shall update the SOPs whenever business processes are modified after consultation with and approval by the COR, within 10 business days.

The development of the SOPs shall be based, in part, upon current, existing CTEP business rules. Business rules can change based on emerging Program needs that have been identified by NCI Leadership or changing FDA or OHRP regulations. Business rules may also change based on new technology or IT software that becomes available provided by the Government. SOPs must be reviewed by the Contractor at least yearly after the implementation date of the SOP.

• The Contractor shall provide any scheduled reports and conduct special queries of CTEP CORE, as directed by the COR. To protect proprietary data, all requests from non-CTEP sources shall first be reviewed and approved by the COR. Scheduled reports will include reports required for the evaluation of the QASP.

Regular scheduled reports are reports that can be generated by the Contractor through the CTEP CORE. The Contractor shall work with the COR to determine the need for any additional scheduled reports to be generated, based upon CTEP business needs.

• The Contractor shall provide presentations that communicate processes or results on activities to CTEP leadership. The Contractor shall first give the presentation to the COR for review. The Contractor shall then deliver the presentations, after consultation with and approval by the COR.

Quality Assurance Surveillance Plan

• The Contractor shall develop a Quality Assurance (QA) plan that addresses all performance metrics in the

Quality Assurance Surveillance Plan (QASP). The QASP measures performance in areas of timeliness and quality and is conducted on a semiannual basis. The Contractor shall produce reports, at the request of the COR, to assist in the evaluation of performance against the QASP. The QA plan may address other business processes or areas that fall outside the scope of the QASP. The QA plan shall provide a process to address and resolve any area of performance that falls beneath stated acceptable levels. The Contractor shall have the opportunity to research and prepare a response for the reconsideration of the assessment of a QASP measure.

Other PIO Program Support

Attachment 3 – Statement of Work Page 6

• The Contractor shall conduct two (2) satisfaction surveys annually. One survey shall measure the satisfaction of CTEP personnel (including CTEP contractors) with PIO services. The other survey shall measure the satisfaction of the customers that the PIO serves, outside of CTEP personnel. The COR shall have the opportunity to review the survey tool(s) prior to distribution. The Contractor shall collect, analyze and report the findings of the survey to the COR within one month following the completion of the survey.

• The Contractor shall conduct a minimum of four (4) but not exceeding twelve (12) training programs annually. The programs are developed by CTEP and will be at least one (1) hour in length and can occur in person, be web-based or conducted via a video conference. The programs shall be delivered to CTEP personnel, CTEP contractors or submitters and submitter personnel who interact with CTEP, as directed by the COR. The training programs shall serve as orientation of new personnel (i.e., CTEP personnel, CTEP contractors or submitters, and submitter personnel who interact with CTEP), training of new processes, or updates on existing processes. The Contractor shall measure the effectiveness of the programs (see the QASP for additional information on this aspect).

• The Contractor shall perform beta testing of systems to assist in the development or enhancement of IT tools through affecting CTEP processes, after consultation with and approval by the COR, and including, but not limited to, the review of IT project plans and the testing of the IT tools.

• The Contractor shall work with Government personnel outside of CTEP on matters that involve or affect

CTEP protocol development processes and activities, after consultation with and approval by the COR.

• In addition to the deliverables specified in other sections of the Statement of Work, the contract shall provide the following technical reports to the COR: a monthly progress report, annual progress report, and final progress report.

Transition Activities

• Phase-In Transition

The Contractor shall develop and submit a draft Phase-In Transition Plan at the time of proposal, which shall describe the Contractor’s strategy for taking over work from the incumbent Contractor, if required to ensure continuity of PIO services. The plan must include plans for provision of key personnel; transfer of relevant files, records, materials and data; transition of all activities from the incumbent Contractor.

Within 5 business days of award, the draft phase-in transition plan shall be revised, if necessary, and the draft Phase-in Transition Plan shall become the Final Phase-in Transition Plan upon approval of the COR.

The Final Phase-in Transition Plan shall be followed to ensure an orderly, secure, efficient, and expedient transition of all contract activities. Concerns anticipated or encountered shall be immediately communicated to the COR and an approved resolution pursued.

Phase-Out Transition

The Contractor shall, within 90 days before the completion of the contract, submit a plan for the transfer of all materials stored by the Contractor to the successor Contractor. This plan shall include a quality assurance element that provides for determination that all files and data have been completely and accurately transferred to the successor Contractor. This plan shall be reviewed and approved by the COR.

• In the event that The Contractor is not awarded the successor award, the Contractor shall assist in the transition of this contract to a successor Contractor. The transition period shall consist of 60 calendar days with a Transition-Out Plan due 90 days prior to the expiration of the contract. The following shall apply only to a transition wherein the Contractor is not the recipient of the successor award.

• Contractor shall provide the successor Contractor with detailed briefings regarding the policies and procedures

Attachment 3 – Statement of Work Page 7 for managing all aspects of the project. As part of these detailed briefings, the Contractor shall provide the successor Contractor with all documentation of PIO processes and products, which shall include, but not be limited to, SOPs, orientation materials, training materials, presentations on PIO activities and samples of PIO-generated reports.

• The Contractor shall provide instruction to the successor Contractor on the policies and procedures utilized in the performance of the contract. This instruction shall be accomplished by permitting personnel of the successor Contractor to work with current contract personnel in an apprentice capacity.

Section 508 Requirements The following 508 standards shall be employed:

Technical Criteria:

E205.1 General -Electronic content shall comply with E205.

E205.2 Public Facing -Electronic content that is public facing shall conform to the accessibility requirements specified in E205.4.

602 Support Documentation 603 Support Services 302 Functional Performance Criteria

E207.1 General - Where components of ICT are software and transmit information or have a user interface, such components shall conform to E207 and the requirements in Chapter 5 E207.2 WCAG Conformance - User interface components, as well as the content of platforms and applications, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

E207.2.1 Word Substitution -When Applying WCAG to Non-Web Software For non-Web software, wherever the term “Webpage” or “page” appears in WCAG 2.0 Level A and AA Success Criteria and Conformance Requirements, the term “software” shall be substituted for the terms “Web page” and “page”.

In addition, in Success Criterion in 1.4.2, the phrase “in software” shall be substituted for the phrase “on a Web page.”

E207.3 Complete Process for Non-Web Software - Where non-Web software requires multiple steps to accomplish an activity, all software related to the activity to be accomplished shall conform to WCAG 2.0 as specified in E207.2.

Exceptions:

E501.1 Scope - Where Web applications do not have access to platform accessibility services and do not include components that have access to platform accessibility services, they shall not be required to conform to 502 or 503 provided that they conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

Functional Performance Criteria:

301.1 Scope - The requirements of Chapter 3 shall apply to ICT where required by 508 Chapter 2 (Scoping Requirements), 255 Chapter 2 (Scoping Requirements), and where otherwise referenced in any other chapter of the Revised 508 Standards or Revised 255 Guidelines.

302.1 Without Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that does not require user vision.

302.2 With Limited Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited vision.

https://buyaccessible.gov/ict-accessibility#e205_1_general https://buyaccessible.gov/ict-accessibility#e205_2_public_facing https://buyaccessible.gov/ict-accessibility#602__603__302 https://buyaccessible.gov/ict-accessibility#602__603__302 https://buyaccessible.gov/ict-accessibility#602__603__302 https://buyaccessible.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 https://buyaccessible.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 https://buyaccessible.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 https://buyaccessible.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 https://buyaccessible.gov/ict-accessibility#e501_1_scope_exception https://buyaccessible.gov/ict-accessibility#e301_1 https://buyaccessible.gov/ict-accessibility#e302_1

Attachment 3 – Statement of Work Page 8

302.3 Without Perception of Color - Where a visual mode of operation is provided, ICT shall provide at least one visual mode of operation that does not require user perception of color.

302.4 Without Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that does not require user hearing.

302.5 With Limited Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited hearing.

302.6 Without Speech - Where speech is used for input, control, or operation, ICT shall provide at least one mode of operation that does not require user speech.

302.7 With Limited Manipulation - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that does not require fine motor control or simultaneous manual operations.

302.8 With Limited Reach and Strength - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that is operable with limited reach and limited strength.

302.9 With Limited Language, Cognitive, and Learning Abilities - ICT shall provide features making its use by individuals with limited cognitive, language, and learning abilities simpler and easier.

https://buyaccessible.gov/ict-accessibility#e302_1 https://buyaccessible.gov/ict-accessibility#e302_1 https://buyaccessible.gov/ict-accessibility#e302_1

Attachment 3 – Statement of Work Page 9

Appendix 1 – PIO Document Counts

FY08 (16 PIO

FTEs)

FY09 (16 PIO

FTEs)

FY10 (16 PIO

FTEs)

FY11 (16 PIO

FTEs)

FY12 (16 PIO

FTEs)

FY13 (11 PIO

FTEs)

Amendments 1269 1348 2157 1841 1211 1034 Revisions 292 375 613 286 274 283 Protocols 182 260 225 185 183 165 Concepts 42 43 53 77 77 57 LOIs 172 476 269 248 306 130 of

P ro to co ls , C on ce pt s, L O

Is , A m en dm en ts

R ev is io ns R ec ei ve d

Detailed Protocol Workload - Protocols, Concepts, LOIs, Amendments & Revisions

(FY08-13)

Attachment 3 – Statement of Work Page 10

Appendix 2 – Definitions and References

Definitions

AE – Adverse Event – An unexpected medical problem that happens during treatment. Adverse events do not have to be caused by the drug or therapy being studied, and they may be mild, moderate, or severe.

AQL – Acceptable Quality Level

BRP – Biometrics Research Program, DCTD, NCI – Statistical Branch who reviews CTEP protocols

BRC- Biomarker Review Committee- The committee within NCI that meets weekly to review all new biomarkers proposed in potential studies.

CDE – Common Data Elements – Standardized language for case report forms used in reporting data collected during clinical trials

CDP – Cancer Diagnosis Program, DCTD, NCI – Laboratory study experts

CIB – Clinical Investigations Branch, CTEP, DCTD, NCI

CIRB – Central Institutional Review Board

CBIIT – Center for Biomedical Informatics and Information Technology, NIH IT contractor

COR- Contracting Officer’s Representative

COTS – Commercial off-the-shelf product. A product which can be purchased commercially without being specifically developed for a client. The contractor installs and maintains the product for the client.

CRADA – Clinical Research and Development Agreement

CRF – Case Report Form

CTA – Clinical Trials Agreement

CTCAE – Common Terminology Criteria for Adverse Events – CTEP's adverse event language used to standardize data reporting and to allow for easier analysis across trials

CTEP – Cancer Therapy Evaluation Program, DCTD, NCI

CTEP-AERS – CTEP Adverse Event Reporting System – A system through which any serious, fatal or life-threatening adverse event that is thought to be drug or treatment related is reported immediately to the drug sponsor.

Part of the CTEP CORE.

CTEP CORE – CTEP Clinical Oncology Research Enterprise

CTMB – Clinical Trials Monitoring Branch, CTEP, DCTD, NCI

CTMB-AIS – CTMB Audit Information System. Part of the CTEP CORE.

Attachment 3 – Statement of Work Page 11

CTMS – Clinical Trials Monitoring Service

CTRP- Clinical Trials Reporting Program. This NCI Program is responsible for data management in ClinicalTrials.gov for CTEP sponsored trials and compliance with FDAAA.

CTSU – Cancer Trials Support Unit. This project coordinates participation in NCI-sponsored clinical trials.

DARTS – Drug Authorization, Review and Tracking System. Part of the CTEP CORE.

DCP – Division of Cancer Prevention, NCI – Another Division within NCI that focuses on cancer prevention research

DCTD - Division of Cancer Treatment and Diagnosis, NCI

DHHS – Department of Health and Human Services

DTP – Developmental Therapeutics Program, DCTD, NCI

FDA – Food and Drug Administration

FDAAA- FDA Amendments Act

FISMA – Federal Information Security Management Act

Form FDA 1572 – Referred to as a “Statement of Investigator”; it is a requirement of section 505(i) of the Food, Drug and Cosmetic Act and paragraph 312.1 of Title 21 CFR, that an investigator complete this form as a condition for receiving and conducting clinical trials involving investigational drug(s). It includes the investigator’s training and experience and provides for legal certifications.

HHS – Health and Human Services

IDB – Investigational Drug Branch, CTEP, DCTD, NCI

IND – Investigational New Drug Application – An IND is a request for authorization from the Food and Drug Administration to administer an investigational drug or biologic product to humans.

IRB - Institutional Review Board – A IRB is an outside body composed of doctors and patient advocates that review research for human subject protections.

LOI – Letter of Intent – An idea for a phase I or phase II trial submitted for review by CTEP.

NCI – National Cancer Institute

NIH – National Institutes of Health

NSC # - National Service Center (anachronism)-Numbering system for study agents.

OEWG- Operational Efficiency Working Group. The OEWG has put forth recommendations on timelines for protocol activation.

PIO – Protocol and Information Office, CTEP, DCTD, NCI. The Protocol Information Office is located at 9609

Attachment 3 – Statement of Work Page 12

Medical Center Drive, Rockville, MD with CTEP.

PMB – Pharmaceutical Management Branch, CTEP, DCTD, NCI

PTMA- Project Team Member Application- An application to serve on an agent specific project team

PRC – Protocol Review Committee, CTEP – The committee within CTEP that meets weekly to review all new protocol submissions.

Protocol Related Documents – CTEP receives numerous types of documents used in the protocol development process. These documents include, but are not limited to, PTMAs, LOIs and Concepts representing pre-protocol ideas as well as the Protocol including revised protocols (changes made prior to final CTEP approval) and amendments (changes made after final CTEP approval). Protocol related documents also include protocol submission worksheets and change memos. Each type of submission (PTMA, LOI, Concept, Protocol, Revisions, and Amendments) require the use of a specific template or the addition of the protocol submission worksheet or change memo. The correct collection of documents submitted to CTEP based on the type of submission is what makes up a complete submission.

PRS – Performance Requirements Summary

PSW – Protocol Submission Worksheet – A worksheet used to organize various administrative aspects of a protocol to facilitate database abstraction.

QA – Quality Assurance

QASP – Quality Assurance Surveillance Plan

QOL – Quality of Life – A commonly studied aspect of clinical trials.

RAB - Regulatory Affairs Branch, CTEP, DCTD, NCI

RABITS – Regulatory Affairs Branch Information Tracking System. Part of the CTEP CORE

RUP – Rational Unified Process

SMARTS – Scientific Management of Agents Review and Tracking System. Part of the CTEP CORE.

Subgroup or stratum – A unique patient characteristic that is utilized to uniformly group or stratify patients for separate data analyses.

Submitter – An organization that conducts a CTEP sponsored clinical trial. May be a cancer center, ETCTN or NCTN group, consortium, NCI Clinical Center for Research, or other type of clinical trial delivery site responsible for interacting with CTEP.

TAC/TAD - Treatment Assignment Code/Descriptor – Standardized codes describing the various treatment options on a protocol.

References:

CTEP Home Page - http://ctep.cancer.gov/ http://ctep.cancer.gov/

ICT Accessibility Requirements Statement per the Revised Section 508 of the Rehabilitation Act

Content Management Systems

Electronic Content

E205.1 General -

Electronic content shall comply with E205.

E205.2 Public Facing -

Electronic content that is public facing shall conform to the accessibility requirements specified in E205.4.

602 Support Documentation - 603 Support Services - 302 Functional Performance Criteria -

Software

E207.1 General -

Where components of ICT are software and transmit information or have a user interface, such components shall conform to E207 and the requirements in Chapter 5

E207.2 WCAG Conformance -

User interface components, as well as the content of platforms and applications, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

E207.2.1 Word Substitution -

When Applying WCAG to Non-Web Software For non-Web software, wherever the term “Web https://section508.gov/ict-accessibility#e205_1_general https://section508.gov/ict-accessibility#e205_2_public_facing https://section508.gov/ict-accessibility#602__603__302 https://section508.gov/ict-accessibility#602__603__302 https://section508.gov/ict-accessibility#602__603__302 https://section508.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 https://section508.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 https://section508.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 page” or “page” appears in WCAG 2.0 Level A and AA Success Criteria and Conformance Requirements, the term “software” shall be substituted for the terms “Web page” and “page”. In addition, in Success Criterion in

1.4.2, the phrase “in software” shall be substituted for the phrase “on a Web page.”

E207.3 Complete Process for Non-Web Software -

Where non-Web software requires multiple steps to accomplish an activity, all software related to the activity to be accomplished shall conform to WCAG 2.0 as specified in E207.2.

E504.1 General -

Where an application is an authoring tool, the application shall conform to 504 to the extent that information required for accessibility is supported by the destination format.

E504.2 Content Creation or Editing -

Authoring tools shall provide a mode of operation to create or edit content that conforms to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1) for all supported features and, as applicable, to file formats supported by the authoring tool.

Authoring tools shall permit authors the option of overriding information required for accessibility.

E504.2.1 Preservation of Information Provided for Accessibility in Format Conversion -

Authoring tools shall, when converting content from one format to another or saving content in multiple formats, preserve the information required for accessibility to the extent that the information is supported by the destination format.

E504.2.2 PDF Export -

Authoring tools capable of exporting PDF files that conform to ISO 32000-1:2008 (PDF 1.7) shall also be capable of exporting PDF files that conform to ANSI/AIIM/ISO 14289-1:2016 (PDF/UA-1) (incorporated by reference, see 702.3.1).

E504.3 Prompts -

Authoring tools shall provide a mode of operation that prompts authors to create content that conforms to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1) for supported features and, as applicable, to file formats supported by the authoring tool.

E504.4 Templates -

Where templates are provided, templates allowing content creation that conforms to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1) shall be provided for a range of template uses for supported features and, as applicable, to file formats supported by the authoring tool.

Exceptions:

E501.1 Scope -

Where Web applications do not have access to platform accessibility services and do not include components that have access to platform accessibility services, they shall not be required to conform to 502 or 503 provided that they conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, https://section508.gov/ict-accessibility#e207_1__e207_2__e207_2_1__e207_3 https://section508.gov/ict-accessibility#e504_1__e504_2__e504_2_1 https://section508.gov/ict-accessibility#e504_1__e504_2__e504_2_1 https://section508.gov/ict-accessibility#e504_1__e504_2__e504_2_1 https://section508.gov/ict-accessibility#e504_2_2__e504_3__e504_4 https://section508.gov/ict-accessibility#e504_2_2__e504_3__e504_4 https://section508.gov/ict-accessibility#e504_2_2__e504_3__e504_4 https://section508.gov/ict-accessibility#e501_1_scope_exception see 702.10.1).

ICT Support and Services

E208.1 General -

Where an agency provides support documentation or services for ICT, such documentation and services shall conform to the requirements in Chapter 6.

E601.1 Scope -

The technical requirements in Chapter 6 shall apply to ICT support documentation and services where required by 508 Chapter 2 (Scoping Requirements), 255 Chapter 2 (Scoping Requirements), and where otherwise referenced in any other chapter of the Revised 508 Standards or Revised 255 Guidelines.

E602.1 General -

Documentation that supports the use of ICT shall conform to 602.

E602.2 Accessibility and Compatibility Features -

Documentation shall list and explain how to use the accessibility and compatibility features required by Chapters 4 and 5. Documentation shall include accessibility features that are built-in and accessibility features that provide compatibility with assistive technology.

E602.3 Electronic Support Documentation -

Documentation in electronic format, including Web-based self-service support, shall conform to Level A

E602.4 Alternate Formats for Non-Electronic Support Documentation -

Where support documentation is only provided in non-electronic formats, alternate formats usable by individuals with disabilities shall be provided upon request.

E602.3 Electronic Support Documentation -

Documentation in electronic format, including Web-based self-service support, shall conform to Level A

E602.4 Alternate Formats for Non-Electronic Support Documentation -

Where support documentation is only provided in non-electronic formats, alternate formats usable by individuals with disabilities shall be provided upon request.

https://section508.gov/ict-accessibility#e208_1_general https://section508.gov/ict-accessibility#e208_1_general https://section508.gov/ict-accessibility#e602_1_general https://section508.gov/ict-accessibility#e602_1_general https://section508.gov/ict-accessibility#e602_1_general https://section508.gov/ict-accessibility#e602_1_general https://section508.gov/ict-accessibility#e602_3__e602_4 https://section508.gov/ict-accessibility#e602_3__e602_4

Functional Performance Criteria:

301.1 Scope - The requirements of Chapter 3 shall apply to ICT where required by 508 Chapter 2 (Scoping Requirements), 255 Chapter 2 (Scoping Requirements), and where otherwise referenced in any other chapter of the Revised 508 Standards or Revised 255 Guidelines.

302.1 Without Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that does not require user vision.

302.2 With Limited Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited vision.

302.3 Without Perception of Color - Where a visual mode of operation is provided, ICT shall provide at least one visual mode of operation that does not require user perception of color.

302.4 Without Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that does not require user hearing.

302.5 With Limited Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited hearing.

302.6 Without Speech - Where speech is used for input, control, or operation, ICT shall provide at least one mode of operation that does not require user speech.

302.7 With Limited Manipulation - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that does not require fine motor control or simultaneous manual operations.

302.8 With Limited Reach and Strength - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that is operable with limited reach and limited strength.

302.9 With Limited Language, Cognitive, and Learning Abilities - ICT shall provide features making its use by individuals with limited cognitive, language, and learning abilities simpler and easier.

Instructions

The Accessibility Requirements Report should be incorporated into the solicitation requirements document (SOO, SOW, PWS, etc.). Please go to the Revised 508 Standards Toolkit (https://section508.gov/manage/program-roadmap) for further information on the procurement process.

https://section508.gov/ict-accessibility#e301_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/ict-accessibility#e302_1 https://section508.gov/manage/program-roadmap

Recomp – “Operation and Support of the Cancer Therapy Evaluation Program’s (CTEP) Protocol and Information Office

(PIO)”

ATTACHMENT 5: List of Government Furnished Property:

Each Contractor will receive:

One cubicle office at NCI Shady Grove One government issued laptop and docking station Two flat screen wide monitors One telephone with an NCI direct telephone number

Attachment 6

SECTION K - REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

Updated through FAC 2005-95 Last updated: 01/2017

This SECTION is made up of nine parts as follows:

1. Annual Representations and Certifications, FAR 52.204-8

2. Commercial and Government Entity Code Reporting, FAR 52.204-16

3. Predecessor of Offeror, FAR 52.204-20

4. Information Regarding Responsibility Matters, FAR 52.209-7

5. Cost Accounting Standards

6. Certification Regarding Trafficking in Persons Compliance Plan

7. Certification Regarding Environmental Tobacco Smoke

8. Certification of Institutional on Financial Conflicts of Interest

9. Disaster or Emergency Area Representation

To Be Completed by the Offeror: This document must be completed and included as part of your Business Proposal. By submission of its signed offer, the offeror makes the following Representations and Certifications:

1. ANNUAL REPRESENTATIONS AND CERTIFICATIONS (JAN 2017), FAR Provision 52.204-8

(a)(1) The North American Industry Classification System (NAICS) code for this acquisition is ____________ [insert NAICS code].

(2) The small business size standard is ____________ [insert size standard].

(3) The small business size standard for a concern which…