The resources listed below provide information on how to collect and manage research data. Resources on data protection are also provided. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.

I. Disaster Recovery Plan
II. Data Protection
III. Case Report Form Development and Monitoring
IV. Data Management and Storage
V. Managing Equipment and Facilities
VI. Documentation

I. Disaster Recovery Plan

(Disaster recovery and business continuity plan)

• Non-profit association of professionals dedicated to the exchange of information on all aspects of business continuity management, from emergency response to the resumption of business as normal | Disaster Recovery Information Exchange
• Disaster preparedness and recovery plan | U.S. Small Business Administration
• Business continuity plan | Federal Emergency Management Agency (FEMA) | U.S. Department of Homeland Security (DHS)

II. Data Protection

(Protocols, passwords)

• Selected U.S. Food and Drug Administration (FDA) Good Clinical Practice (GCP)/Clinical Trial Guidance Documents | U.S. Food and Drug Administration (FDA)
• Proposed Regulations and Draft Guidances | FDA
• Data Management Practices | U.S. Department of Health & Human Services (HHS) - Office for Human Research Protections (OHRP)

III. Case Report Form Development and Completion Monitoring

• Data management: Case Report Forms (CRFs) and Source Documentation | Ohio State University Center for Clinical and Translational Science
• Guidelines for Designing And Completing Case Reports Forms for Phase I & II Chemoprevention Trials | National Cancer Institute (NCI) - Division of Cancer Prevention
• Data management: CRFs and Source Documentation | National Institutes of Health (NIH) - National Center for Complementary and Integrative Health (NCCIH)

IV. Data Management and Storage

(Short-term and long-term data management, storage, and archiving)

• Introduction to responsible conduct of research | U.S. Department of Health & Human Services (HHS) - Office of Research Integrity (ORI)
• Technical and Operations Best Practice: Biospecimen Collection, Processing, Storage, Retrieval, and Dissemination | National Cancer Institue (NCI) - Office of Biorepositories and Biospecimen Research
• Archiving the Phenome: Clinical Records Deserve Long-term Preservation | Milton Corn, MD | Journal of the American Medical Informatics
• Guidelines to facilitate production of a data handling protocol | Association for Clinical Data Management
• Maintenance and Storage of Research Records | Ohio State University Center for Clinical and Translational Science
• Best Practice for Biospecimen Resources: These voluntary guidelines are available online for free and provide an outline of how to incorporate Best Practices into a site’s internal procedures. The guidelines are divided into two broad areas including “Technical and Operational Best Practices” and “Ethical, Legal, and Policy Best Practices.” | NCI

V. Managing Equipment and Facilities

(Handling and managing equipment, instruments, and laboratory facilities)

• Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards | National Center for Biotechnology Information
• World Health Organization (WHO) Good Practices for Pharmaceutical Quality Control Laboratories | World Health Organization (WHO)
• Equipment Management Plan | University of Michigan
• Requirements for Pharmacy Facilities at Division of the Acquired Immunodeficiency Syndrome (AIDS) Supported Clinical Research Sites | National Institutes of Health (NIH) - National Institute of Allergies and Infectious Diseases

VI. Documentation

(Regulatory documentation, source documentation, Institutional Review Board (IRB) documentation, etc.)

• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs (Form FDA 1572) | U.S. Department of Health & Human Services (HHS) | U.S. Food and Drug Administration (FDA)
• ASCO Research Program Quality Assessment Tool | ASCO
• Regulatory Documentation | Ohio State University Center for Clinical and Translational Science
• Data Management: Case Report Forms (CRF) and Source Documentation | Ohio State University Center for Clinical and Translational Science
• Quality Assurance and Educational Standards for Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
• Clinical Trial Assessment of Infrastructure Matrix Tool (CT-AIM) | National Cancer Institute - AccrualNet™
• ReCAP: Clinical Trial Assessment of Infrastructure Matrix Tool to Improve the Quality of Research Conduct in the Community | JOP
• Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual | JOP