REQUEST FOR PROPOSAL. Statistical Programing Expert Crohn s Disease Therapeutic Area User Guide. October 2018

Transcription

1 REQUEST FOR PROPOSAL Statistical Programing Expert Crohn s Disease Therapeutic Area User Guide - SPONSOR: CDISC October

2 Contents Executive Summary... 3 Project Description... 3 Task Description... 3 Response Requirements... 4 A: Description of Expertise... 4 B: Contract Requirements... 4 Contact Information... 5 FAQs

3 Executive Summary CDISC is preparing to develop several Therapeutic Area User Guides over the course of the next 2 years. We are contacting you to procure your interest and capability to provide expert ADaM input during the development of these Therapeutic User Guides. Project Description CDISC has won a grant for the development of a Therapeutic Area Guide for Crohn s Disease. Activities are scheduled to start in December 2018 and end in December 2020 Task Description This section provides a not-to-exceed estimation of the work. The available proposed working hours will be used to create the deliverables. In the case the actual workload is in danger of overrunning the proposed workload, this must be communicated to the project manager and mitigating steps taken early on in the process. There is no room for budget overruns. The ADaM consultant will be part of a large cross-functional development team that will include Metadata developers, terminologist, TA clinical and statistical experts, Project management, IT, Communications. The ADaM consultant will work with the team to develop the follow items for inclusion in the emerging standards documentation after clinical experts have identified and defined the core analysis endpoints. Main ADaM Expert deliverables include: ADaM Results, Table Figures Listings (TFL) with supporting metadata ADaM Subject Level data Set (ADSL) with metadata to support analysis ADaM analysis data sets with metadata to support analysis ADaM explanatory text as needed for inclusion in the standard (on the CDISC wiki) Review the emerging document to ensure accuracy and correctness If you accept this assignment, we assume you also accept the workload estimations below: 3

4 Task Details Profile Exp Timeline Total Hours STAGE 0 : Kick off meeting & Project Scoping Meeting Preparation ADaM and Statistical Expert FEB Meeting participation ADaM and Statistical Expert 4.00 STAGE 1: Identification / Modeling of Concepts Statistical input, endpoint and method identification. ADaM and Statistical Expert MAY Researching quidance, consulting with clinical and data management experts. STAGE 2: Completion of Draft Standards Complete ADaM examples and get buy-in from the ADaM and Statistical Expert OCT ADaM team STAGE 3a: Internal Review Participate in comment resolution. ADaM and Statistical Expert FEB STAGE 3b: Public Review Participate in comment resolution. ADaM and Statistical Expert JUL STAGE 3c: Public Release - Educational Materials Development Contribute to educational materials development ADaM and Statistical Expert DEC Total hours Response Requirements A: Description of Expertise CDISC is assuming that you will provision 1 ADaM Programming expert with proven ADaM expertise for the duration of the project. You are required to ensure backup and project continuity in case the proposed expert cannot continue the work. Describe the expertise of the proposed consultant Describe your project continuity plan Describe the vision and strategy of your company with respect to the CDISC mission The consultant should be a current, or past, ADaM team member, or be a current or past ADaM instructor. If this is not the case, we assume the consultant will join and participate in the ADaM team. B: Contract Requirements CDISC is a non-profit organization that develops data standards in order to bring treatments faster to patients. While a substantial level of expertise is required in the development of these data standards, CDISC is assuming that you will consider the non-profit nature of this work. The consultant will provide monthly timesheets. Upon written approval of the timesheet, a corresponding invoice must be submitted to CDISC. Any activities that incur expenses must have prior written approval and follow CDISC Operating Policies and Procedures. 4

5 The following CDISC Policies and Procedures apply: POL 001 Code of Conduct & Professional Ethics Policy POL 002 Finance Policy POL 003 Intellectual Property Policy COP 018 Travel Expenses Policy And any other relevant policy and procedure These policies and procedures can be consulted on the CDISC website: Contact Information Marine Laurent VP Finance and HR

6 FAQs Q: How many ADaM and Statistical Experts will you have in this project? A: ADaM Experts we have planned for is one, however if we see a need arising we may add another. But we want to ensure consistency from topic to topic as much as possible. TA Stats experts 1-2 per topic area. Q: Who has final responsibility for the deliverables and the creation thereof? A: What other roles does the project team consist of? CDISC is responsible and is in the process of building a cross-functional team now. This team will include metadata developers, terminologist, TA clinical and statistical experts, Project management, IT, Communications. Q: The ADaM team that is referred to in various places, is that a general ADaM team or is it specific for this project? A: The general ADaM volunteer team, but if the Crohn s Disease work is better placed in sub-team that change will be made. Q: What does it mean to participate in the ADaM team and what do we commit to by doing so? A: The ADaM Stat Programmer consultant must be able to collaborate with the ADaM team, bring the draft ADaM metadata tables and examples to the ADaM team and acquire buy-in. That being the case they need to start attending ADaM volunteer team meetings. These meetings are usually held once every two weeks, 1-hour in duration. CDISC will assist with onboarding. Q: What specific domain knowledge of Crohn s Disease is required? A: ADaM experience required, Crohn s Disease experience preferred. Q: What role and responsibility does the ADaM and Statistical Expert have in the Stage 0 kick-off meeting & project scoping meeting? A: Work with the cross-functional team and provide ADaM stat programming expertise. Q: What role and responsibility does the ADaM and Statistical Expert have in the Stage 1 identification and modelling of concepts? A: ADaM Programmer Expert Deliverables: ADaM Results, Table Figures Listings (TFL) with supporting metadata ADaM Subject Level data Set (ADSL) with metadata to support analysis ADaM analysis data sets with metadata to support analysis ADaM explanatory text as needed for inclusion in the standard (on the CDISC wiki) Review the emerging document to ensure accuracy and correctness Q: Is it correct to assume that for stages 3a, 3b, and 3c participation and input is required, but that this process is led by another team member? A: Yes Q: Our input is for the ADaM part only, is the development of the ADaM part based on an existing SDTM part? A: Yes 6