METRCMajor Extremity Trauma Research Consortium

METRC Policy & Procedure Manual

The METRC Policy & Procedure Manual (PPM) is a compendium of documents which describes the policies and procedures that are broadly relevant to METRC as an organization. PPM content is being produced, published, and updated on a frequent and ongoing basis. Please use the Policy & Procedure Manual Index (Excel file linked below) as tool for identifying the content that is currently available and for determining which pieces of the PPM are applicable to you in your role within METRC. 

Policy & Procedure Manual Index

  1. METRC Policy & Procedure Manual
    1. Table of Contents
    2. Policy & Procedure Manual Index
    3. Content Development & Document Standards
    4. Dissemination & Training Plan
      1. Template PPM Training Log for MCC Personnel
  2. METRC Governance & Leadership
    1. Executive Committee
    2. Standing Committee Charters
      1. Science Committee
      2. Publications & Presentations Committee
        1. METRC Publications & Presentations Guidelines
          1. Appendix A- Defining the Research Group
          2. Appendix B- Corporate Authorship Framework
          3. Appendix C- Authorship Form
          4. Appendix D- Conference Abstract Submission Checklist
      3. Implementation & Quality Committee
      4. Data Standards Committee
      5. Emerging Investigators Committee
      6. Rehabilitation Engagement
    3. Conflict of Interest Management
  3. METRC Marketing & Communications ​
    1. Site Membership in METRC
      1. METRC Site Admission Processes
    2. METRC Website
      1. Public
      2. Private
    3. METRC Annual Report
    4. Document Management
      1. Dropbox Information
    5. Conferencing & Communication Tools
      1. Listservs
      2. Web Conferencing
      3. Audio Conferencing
  4. METRC Finance & Contracts​
    1. MCC Funding Minimums
    2. Subagreements with Sites
      1. Effort formula
    3. Master Service Agreements & Task Orders
    4. Enrollment & Follow-up Payments
      1. Payment Schedules
      2. Invoicing Procedures
    5. Intellectual Property Policy
  5. Study Management​
    1. Protocol Committees
    2. MCC Study Teams
      1. Study Team Roles & Responsibilities
    3. Selecting Sites for Participation
    4. Protocol Development
      1. Protocol
        1. Templates
      2. Consent Form(s)
        1. Templates
        2. Required DoD Language
        3. Policy on LARs
        4. HIPPA Compliance
      3. Data Collection Portfolio
        1. CRFs
        2. Data Dictionary
          1. METRC Master Data Dictionary
        3. Guidance Document
    5. Regulatory Review & Approval
      1. Master Protocol Review
        1. IRB
        2. DoD HRPO
      2. Site Review
        1. IRB
        2. DoD HRPO
      3. Site Electronic Regulatory Binders
      4. Personnel Training Requirements and Tracking
        1. Certification Document Repository
      5. Tracking Approval and Study Status Data
        1. Database Table/Form: Study Local
          1. Guidance for Assigning Site Status Variable
      6. Continuing Review
        1. Master Protocol
          1. IRB
          2. DoD HPRO
        2. Site Protocols
          1. IRB
          2. DoD HPRO
      7. Single IRB
    6. Study Implementation
      1. Study Trainings
      2. Standards & Procedures for Clinical Site Certification
        1. Clinical Site Certification Documentation Checklist
        2. Clinical Site Certification Form Template
        3. Clinical Site Certification Approval Email Template
        4. Standards & Procedures for Provisional Site Certification
          1. Provisional Certification Approval Email Template
          2. Provisional Certification Assessment Email Template
          3. Transition from Provisional to Full Certification Approval Email Template
      3. Managing FAQs
      4. Follow-up Policies & Guidance
      5. Patient Transfers
      6. Reporting AEs, SAEs, and Unanticipated Problems
    7. Data Management
      1. Servers
      2. REDCap
      3. Data Breach Policies
      4. Reporting
    8. Study Close Out
      1. Study Closure Procedures
    9. Data Analyses
      1. Vetting Analysts at METRC Centers
      2. Secondary Data Analyses
  6. Data Quality Assurance Plan
    1. Data Quality Assurance
      1. METRC Data Dictionary
        1. Construct, Domain, Data Elements
        2. Definitions, Guidance (short-form), and References
        3. Designation as a Data Standard, Preferred Data Element, or Ad Hoc data element
          1. Data Standards Policy
        4. Concordance Table
      2. Data Collection Guidance Manual (long-form guidance)
        1. Administrative Forms
          1. AF01 Patient Close Out
          2. AF03 Missed Visit Form
        2. Patient Interviews & PROs
        3. Medical Record Reviews and other EMR-Sourced Data
        4. Surgeon-Sourced Data
          1. Policy on Treating Physician Data Element
        5. Trauma Registry Sourced Data
        6. Study Specific Data Collection Guidance
    2. Data Quality Control
      1. Data Safety & Monitoring Board
        1. DSMB Charter
        2. Procedure for Scheduling DSMB Meetings
        3. DSMB Meeting Procedures
        4. DSMB Reports
        5. Standard Procedures for Obtaining and Distributing DSMB Determination Letters
      2. Monitoring Activities
    3. I&Q Stuff
    4. Data Sharing Plan & Procedures
  7. VII. Coordinating Center
    1. Organization
      1. Organizational Chart
      2. MCC Organizational Units & Roles
        1. Investigators
        2. Study Teams
          1. Project Directors
          2. Study Managers
          3. Research Assistants
        3. Analysis Core
          1. Sr. Biostatisticians
          2. Data Analysts
        4. Informatics Core
          1. Informatics Director
          2. Programmer Analysts
          3. REDCap and CRF Development Assistant
        5. Administration Core
          1. Operations Director
          2. Administrative Coordinator
          3. Editorial Assistant
        6. Finance Core
          1. Finance Director
          2. Budget and Contract Analyst
          3. Budget Specialist
        7. Call Center
          1. Interviewers
    2. MCC Personnel Policies
      1. Human Subjects Research Training Requirements
      2. Office Hours Policy
      3. Paid Time Off
    3. METRC Administrative Database
      1. METRC Directory
  8. Data Quality Assurance
    1. Submitting New Study Ideas to METRC
      1. Form
      2. Science Committee Process
      3. Executive Committee Process
    2. Project Management
      1. Organizing Meeting
    3. Grant Boilerplate
    4. Institutional Timelines
      1. JHURA Policies and Deadlines
    5. MCC Minimum Funding Policy
  9. Standard Operating Procedures
    1. Site Management
    2. Essential Document Management
    3. Human Subjects Recruitment & Safety Procedures
      1. Example Informed Consent Form (JHMI sIRB)
    4. Regulatory Review
    5. Site Certification
      1. Document Checklist Template
      2. Certification Approval Form Template
      3. Certification Approval Template
    6. Data Management - REDCap Servers