Resources listed below cover the fundamental elements of initiating a clinical trial at a research site. Resources include site quality assessment measures, education and training resources for site staff, and guides for federal regulation compliance among others. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.

I. Protocol Handling
II. Industry Pre-study Site Visit
III. Site Initiation Meetings and Visits
IV. Informed Consent Preparation
V. Study Activation
VI. Compliance and Regulations
VII. Submitting a New Study Application to an Institutional Review Board
VIII. Protocol Review & Monitoring Committee

I. Protocol Handling

(Review for feasibility, and approvals)

• The Elements of Success, Conducting Cancer Clinical Trial: A Guide | Coalition of Cancer Cooperative Groups
• Education and Training Resources for Clinical Research Coordinators and Staff | Ohio State University Center for Clinical and Translational Science
• Three sample checklists for feasibility of successfully recruiting for particular trials at your own site | National Cancer Institute (NCI) - AccrualNet™
• Insurance Coverage of Clinical Trials: This resource provides information and highlights on ASCO’s policy efforts around insurance coverage for the routine patient costs for people participating in cancer clinical trials | ASCO
• Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual | Journal of Oncology Practice (JOP)

II. Industry Pre-study Site Visit

• The Elements of Success, Conducting Cancer Clinical Trial: A Guide | Coalition of Cancer Cooperative Groups
• Clinical Trial Start Up Checklist | Stanford University School of Medicine Rearch Management Group
• Education and Training Resources for Clinical Research Coordinators and Staff | Ohio State University Center for Clinical and Translational Science

III. Site Initiation Meetings and Visits

• The Elements of Success, Conducting Cancer Clinical Trials: A Guide | Coalition of Cancer Cooperative Groups
• Clinical Study Initiation Visit Report | National Cancer Institute (NCI) - Division of Cancer Prevention
• Sample Checklist for Site Initiation Visit | Dana Farber Cancer Center
• Education and Training Resources for Clinical Research Coordinators and Staff | Ohio State University Center for Clinical and Translational Science
• ASCO Research Program Quality Assessment Tool | ASCO
• 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 | Journal of Oncology Practice (JOP)

IV. Informed Consent Preparation

• The Elements of Success, Conducting Cancer Clinical Trial: A Guide | Coalition of Cancer Cooperative Groups
• Informed Consent Checklist | U.S. Department of Health & Human Services (HHS)
• Informed Consent Requirements | Ohio State University Center for Clinical and Translational Science
• Informed Consent Perspective | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
• Patient Perspective: Patient Safety and Informed Consent | Cancer.net
• Recommendations for the Development of Informed Consent Documents for Cancer Clinical Trials | National Cancer Institute (NCI)

V. Study Activation

• The Elements of Success, Conducting Cancer Clinical Trial: A Guide | Coalition of Cancer Cooperative Groups
• Sample Checklist for Site Initiation | Dana Farber Cancer Center
• Clinical Study Initiation Visit Report | National Cancer Institute (NCI) - Division of Cancer Prevention
• Three sample checklists for feasibility of successfully recruiting for particular trials at your own site | National Cancer Institute - AccrualNet™
• Insurance Coverage of Clinical Trials: This resource provides information and highlights on ASCO’s policy efforts around insurance coverage for the routine patient costs for people participating in cancer clinical trials | ASCO
• Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual | Journal of Oncology Practice

VI. Compliance and Regulations

(Completing an FDA Form 1572; federally required registering of trials on websites)

• The Elements of Success, Conducting Cancer Clinical Trial: A Guide | Coalition of Cancer Cooperative Groups
• Instructions for Filling Out Form FDA 1572 | U.S Food and Drug Administration (FDA)
• Human Research Regulations | Ohio State University Center for Clinical and Translational Science

VII. Submitting a New Study Application to an Institutional Review Board

• The Elements of Success, Conducting Cancer Clinical Trial: A Guide | Coalition of Cancer Cooperative Groups
• Code of Federal Regulations | U.S. Department of Health and Human Services (HHS) - Office for Human Resource Protections (OHRP)
• Institutional Review Board Frequently Asked Questions | U.S. Food and Drug Administration (FDA)

VIII. Protocol Review & Monitoring Committee

• The Elements of Success, Conducting Cancer Clinical Trial: A Guide | Coalition of Cancer Cooperative Groups
• Essential Elements of a Data Safety and Monitoring Plan for Clinical Trials Funded by the NCI | National Cancer Institute (NCI)