Data Management for BLAAC-PD – Request for Proposals (RFP)

Background

The Global Parkinson’s Genetics Program (GP2) and its implementation partner The Michael J. Fox Foundation (MJFF) are seeking a qualified organization to manage and support the Black and African American Connections to Parkinson’s Disease (BLAAC PD) study data. If your organization also offers clinical trial coordination services, please submit a combined proposal. Organizations that can provide both clinical trial coordination and data management are preferred. More information can be found on the BLAAC PD Clinical Trial Coordination RFP. 

Research on the genetics of PD have largely been conducted with people of European descent. The lack of diversity in this research has negative implications on the generalizability of research discoveries and worsens the existing racial disparities in healthcare. Black and African Americans continue to be underrepresented in PD research. BLAAC PD was launched in 2021 by the Global Parkinson’s Genetics Program (GP2) and is focused on engaging Black and African Americans with and without Parkinson’s disease (PD). The study aims to create a cohort of Black and African American individuals to help genetic researchers understand what PD looks like for Black and African American communities and contribute to a more complete, global picture of the condition. Data analyses seek to identify similarities and/or differences related to genetic data collected from other populations that may provide evidence for application of therapies in development and may illuminate novel targets for additional investigation. 

BLAAC PD is a cross-sectional, multi-center study with 11 active sites across the United States seeking to enroll at least 2,000 volunteers (1,000 with PD and 1,000 without PD). Additional sites to achieve this enrollment goal may be added to the study in 2025 or 2026. The study is currently expected to end in December 2027. The study is funded by the Aligning Science Across Parkinson’s initiative and implemented by MJFF. Currently, one entity oversees clinical trial coordination and a second entity manages the study database in REDCap. The BLAAC PD study protocol has been published here. Case report forms are available upon request. Data from the BLAAC PD study was also utilized in the first major discovery of a novel risk factor for PD in people of African ancestry. Additional information can be found on the BLAAC PD website and ClinicalTrials.gov. 

The selected organization will be responsible for transitioning data collection from BLAAC PD’s current database, quality checking study data, providing data reports to study leadership and GP2, and working collaboratively with BLAAC PD clinical trial management, BLAAC PD study sites, GP2, and MJFF. 

Objectives and Scope of Work

Objectives:

  • Coordinate with study’s current data management team for a smooth transition of the database and oversight.
  • Host and maintain database on Electronic Data Capture (EDC) platform.
  • Redesign and streamline database
  • Collaborate with BLAAC PD study sites, study leadership, clinical trial coordination team, and GP2
  • Create and collate reports from database.

Scope of Work: The selected organization will be responsible for:

  • Transition of Database:
    • Partner with existing data management team to ensure a smooth handover of responsibilities and transfer of historical knowledge.
    • Document and archive previously collected data.
    • Address any transition challenges promptly to ensure there is no disruption in the study. 
  • EDC Service: 
    • Improve database system for data collection/entry, including, but not limited to, branching logic and validation of entered values to support accurate entries and standardized data.
    • Train study sites to access and utilize EDC for data entry. 
    • Manage user access to database.
    • Archive existing data.
    • Designate personnel with technical experience in database management.
  • Study Database Development: 
    • Collaborate with study leadership to redesign the study database, addressing historical challenges to data collection.
    • Develop revised study database on EDC platform and ensure data quality and accuracy.
  • Collaborate with Study Team Members 
    • As needed, train site team members to access and utilize EDC. 
    • Address site team member questions and challenges promptly and efficiently.
    • Collaborate with BLAAC PD’s clinical trial coordination team to ensure data quality, proper information sharing, and on monthly data reports.
    • Collaborate with GP2 team to create sample manifests/reports with relevant and accurate clinical data for sample processing and data sharing.
  • Data Management and Reporting:
    • Monitor data quality routinely and collaborate with Clinical Trial Coordinating Center and/or  study sites to ensure accuracy of data.
    • Monitor timely data reporting to ensure regulatory compliance. 
    • Regularly create reports with relevant data for analysis by study team, including MJFF, study PI, patient engagement specialists, and others. 
    • Compile data manifests necessary for biosample processing, genotyping, and data sharing.

Proposal Requirements

Please address the following sections and submit a final proposal of no more than 5 pages.

The proposal should include the following sections:

  • Organizational Background and Personnel: Please provide a brief description of your organization, team, and professional experiences that directly relate to transition of oversight and cross-sectional, multi-center studies. Please also include copies of key personnel’s resumes. 
  • Transition Plan: Please describe your plan for collaborating with the current data management team and clinical trial coordination team to smoothly transition data collection for the study. Include a timeline and risk mitigation/management approach in your plan.
  • Data Management Plan: Please provide a general overview of your plan for BLAAC PD database management, including the following key needs: 
    • Information on the EDC system and tools/features for managing multi-site clinical trials.
    • Frequency and plan for data quality checks. 
  • Experience with Similar Studies: Please supplement your proposal with up to three examples of different successfully completed projects similar in scope to BLAAC PD, highlighting the following areas: 
    • Your responsibilities 
    • Key challenges addressed
    • Risk management strategies (i.e., how you identified and mitigated risks)
    • Key milestones achieved
  • Budget: Using the MJFF budget template, complete a budget including fees for services, training, and data management for a 1-year contract. 
  • Letters of Recommendation: Please include 1-2 letters of recommendation from individuals/organizations your team has collaborated with, ideally on work similar in scope to BLAAC PD. Letters do not count toward the page limit.

Timeline and Submission Details

Proposal Submission Deadline: Friday, August 8th
Proposal Evaluation Period: Monday, August 11th through Friday, September 12th 
Anticipated Project Start Date: Monday, October 13th (or as soon as appropriate agreements are formed and approved)

Applicants may submit questions by Friday, July 25th to gain additional perspective on project requirements. Please note the MJFF office is closed from Monday, June 30th through Friday, July 4th. Any questions received during that time will be answered promptly once staff return on Monday, July 7th. During the evaluation period, a 30-minute virtual call may be scheduled with your team. 

All questions and proposals should be submitted electronically to:
Naomi Louie
[email protected]