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INTRODUCTION Through this Request for Information (RFI) Notice, the National Cancer Institute (NCI) is conducting market research to determine if capable sources exist for the implementation and suppo... INTRODUCTION Through this Request for Information (RFI) Notice, the National Cancer Institute (NCI) is conducting market research to determine if capable sources exist for the implementation and support of a system to collect and migrate electronic Patient Reported Outcomes data (electronic PRO data). The purpose of this RFI, is to determine if commercial solutions exist that meet NCI’s requirements for an easily managed and secure system to capture patient reported outcome data for NCI-sponsored clinical trials networks, with respect to functionality, support, training, trial/study building, reporting, workflows and efficiency. Interested vendors are encouraged to reply to this notice with a response detailing their PRO data system solution regarding the requirements presented below. The Government does not intend to award a contract on the basis of this RFI, or to otherwise pay for the information solicited. BACKGROUND A patient reported outcome (PRO) is the measurement of any aspect of a patient's health status that comes directly from the patient; in other words, without the interpretation of the patient's responses by a physician or anyone else. Administration of PROs may be through paper and pencil forms, electronic digital capture through the Internet or handheld device, or through an interviewer-administered questionnaire. The most commonly used PRO questionnaires assess one of the following: symptoms and impairments, functioning or disability, wellness or health, or health-related quality of life. NCI funds several clinical trials networks to cover research across the cancer continuum. The Experimental Therapeutics Clinical Trials Network (ETCTN) provides early clinical evaluation of innovative cancer therapies. The NCI Clinical Trials Network (NCTN) Groups designs, develops and conducts phase 2 and 3 cancer treatment trials; and the NCI Community Oncology Research Program (NCORP) Research Bases designs, develops and conducts cancer prevention and control clinical trials and cancer care delivery studies. NCI supports numerous ongoing clinical trials in different stages of development any of which may wish to incorporate electronic PROs. At least three NCI-sponsored clinical trial networks have a current need for efficient electronic collection and integration of PRO data into the enterprise. SCOPE OF WORK This requirement is for software, services, including subject matter expertise of the implementation of an electronic patient report outcomes data system that will align with NCI’s sponsored clinical trials networks as well as the system workflow that aligns with the NCI Clinical Trials Process. Anticipated services encompass the entire clinical trials life cycle of implementing the data collection system, software engineering, enterprise networking, cyber security, operations and maintenance, training, and educational materials and sessions. INFORMATION REQUESTED NCI seeks information on commercially available (or with modification) solutions for collecting electronic PRO data. Respondents should provide a capability statement of their solution using the following estimated usage parameters and requirements: Estimated Scope: Anticipate 15 unique clinical trials per year will be conducted. Each trial has approximately 400 patients that would potentially choose to enter patient reported outcomes in an electronic mode. General System Functionality: Comply with Federal IT security standards, Privacy Act, Health Insurance Portability and Accountability Act (HIPPA), Code of Federal Regulations 21 part 11 (21 CFR 11); Clinical Data Interchange Standards Consortium (CDISC) / Clinical Data Acquisition Standards Harmonization (CDASH) regulations, and Section 508 standards, among others. Compatible with iOS®, Android®, and interface with common web browsers (Microsoft® IE/Edge, Chrome, Safari, Firefox). Allow patients and sites to access the electronic PRO system, accommodating various device types (smartphone, tablet, PC) for patient data entry, allowing access to the PROs at any timepoints during the studies. Allow for secure role-based system access, as well as have different functionalities for the four main user types as listed below: NCI staff Trial Team and Lead Protocol Organizations Site Clinicians and Staff Patients Training and Support: Provide training sessions: for site research staff to train patients to enter patient reported outcomes at a 90% success level and monitor patient compliance. for the research teams to train protocol writers in the set-up of PRO Case Report Forms, (CRFs) assist patient registration, patient data entry and managing the tool. provide email and phone customer support to resolve bugs/errors from 9am to 6pm Eastern Time. create and maintain all user accounts including assigning appropriate roles, study access, system access and password resets. Conduct virtual kick-off meetings at the Clinical Trial Network Meetings (7-10 per year). Provide a ticketing system or process to manage incoming support questions. PRO Trial Build and Reporting Functionality: The electronic PRO data system should be designed in a way that allows for: ease of integrating PRO data from patients into the main clinical trials database for review and analysis by the trial team; flexibility to accommodate clinical trial design specific modifications; user-friendly trial set up by site staff for patients and in-clinic utilization; easy set-up of PRO Case Report Forms (CRFs) including edit checks and skip logic; the trial team to monitor electronic PRO data with lab, imaging, and other clinical data; site clinicians to receive notices for identified, clinical trial specific symptoms reported by patients; notifications, to include: encouraging survey completion by sending automatic reminders based on calendar functions; full audit trail capabilities; automatic notifications and reminders designated by user-preferred methodology including email and text; allowing sites to send manual notifications directly to participants; accommodation for face-based (emoticon) scales or visual scales for patients of all ages; ability to view metrics on usage of PRO data system across multiple trials in the NCI Clinical Trials Network; ability to use multiple PRO questionnaires for a single trial and modify skip patterns according to trial specific parameters; flexibility to change open and closed assessment windows during the course of a trial to adjust for treatment delays; allows patients to fill out electronic PRO instruments at a clinical site without individually logging in to the system. This functionality is beneficial for studies where the trial participants complete few surveys and do not need their own login; facilitation of access to existing, licensed, PRO questionnaires; access to the translation of PRO questionnaires in multiple languages. [Clarification: It is anticipated that the Contractor will not be required to translate the PRO questionnaires, but the system should be able to accommodate PRO assessments that are in other languages. The PRO assessments will be translated prior to inputting into the system.] Participation in NCI Operational Working Groups: Collaborate with the NCI to a create a streamlined process for transition of existing instruments/reporting processes from paper to electronic means. CAPABILITY STATEMENT / INFORMATION SOUGHT Respondents must provide a response that addresses all the requirements set forth in the Information Requested section above, including, but not limited to: A capabilities statement that addresses the functionality requirements above. Generic brochures will not be reviewed. Respondents shall describe their opinions about the difficulty and/or feasibility of the possible solutions and approaches that may currently exist in the marketplace, and information regarding innovative ideas or concepts. Provide information regarding respondents' prior completed projects of similar nature. Provide a breakout of software, hardware and services necessary for the installation of system. Describe the options for hosting your system. Describe the training methods and materials for your solution. Rough Order of Magnitude (ROM) estimate of cost and time to implement the system given the provided scope, to be most advantageous to the Government. Respondents must provide their DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), Women-Owned Small Business, Hub Zone Small Business woman-owned, etc.) pursuant to the applicable NAICS code 541512 and any other information that may be helpful in developing or finalizing the acquisition requirements. The response must include the respondents' technical and administrative points of contact, including names, titles, addresses, telephone, and e-mail addresses. The response is limited to ten (10) pages. The 10-page limit does not include the cover page, executive summary, or references. The response must be submitted to Linda Park at e-mail address: linda.park@nih.gov, and must be received on or before January 9, 2020, 3:00 PM Eastern Time. NAICS Code and Size Standard: In the event a Request for Proposal (RFP) is issued based on this RFI, North American Industry Classification System (NAICS) code 541512 with a small business size standard of $30 million annual receipts is being considered. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).