A variety of online resources are listed below with information about some of the basic considerations when building a clinical research site, including infrastructure, regulatory requirements, patient engagement, access to trials, and best practices. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.
Topics covered include:
I. Community-Based Research 101
II. Building Program Infrastructure
III. Mission Statements and Policies
IV. Research Integrity
V. Regulations
VI. Good Clinical Research Practices
VII. Standard Operating Procedures
VIII. Marketing Your Research Program
IX. Engaging Patients
X. Accessing Clinical Trials
I. Community-Based Research 101
Investigator Resources
- Investigators' Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis (DCTD), National Cancer Institute (NCI) | NCI
- Conducting Clinical Trials: Information for Investigators, Tools for Managing Trials, Registration/Reporting and Ensuring Patient Safety | NCI
- Investigator Functional Competency Guidelines | Association of Clinical Research Professionals (ACRP)
- Webinar Replay: We are Going to Run an Investigator-Initiated Trial? What do we Do? | ACRP (note: this webinar is free to ACRP members)
- Webinar Replay: Drug Development Process: A Review of ICH E8 | ACRP (note: this webinar is free to ACRP members)
Research Program Resources
- Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Clinical Oncology (JCO)
- Basic Steps to Building a Research Program | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Enhancing Oncologist Participation in Research | ASCO Exemplary Attributes Publication Series, JOP
- Tools for Managing Clinical Trials | National Cancer Institute (NCI)
- Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- Part 2: Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- Exemplary Attributes Article Series: an ongoing article series in the Journal of Oncology Practice provides practical information on how to implement the Good Clinical Practice (GCP) guidelines and exemplary attributes | JOP
- 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
- Minimizing Research Delays: Identifying Successful Strategies to Keep a Clinical Trial Moving Forward | JOP
- A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTC, NCI | NCI
- First Clinical Research Resources | First Clinical Research Best Practices Journal
- Best Practices Standards: provides forms, form letters, and other documents for use by clinical research sites | Model Agreements and Guidelines International (These resources require a membership to access.)
- CRC Core Competencies | ACRP
II. Building Program Infrastructure
- Clinical Research Site Infrastructure and Efficiency | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Basic Steps to Building a Research Program | ASCO Exemplary Attributes Publication Series, JOP
- Including Clinical Trials into your Practice: This online module, produced by the National Cancer Institute (NCI), targets healthcare professionals with advanced knowledge of cancer clinical trials who want to better incorporate trials into their practice | NCI
III. Mission Statements and Policies
(e.g., participation in research, selection of clinical trials, clinical trial portfolio and diversity, etc.)
- Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Clinical Oncology (JCO)
- Enhancing Oncologist Participation in Research | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Enhancing Clinical Trial Awareness and Outreach | ASCO Exemplary Attributes Publication Series, JOP
- Cost-Neutral Clinical Research Enterprise | ASCO Exemplary Attributes Publication Series, JOP
- Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- Part 2: Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- To view additional samples online, search in your web browser for: "mission statements research"
IV. Research Integrity
- Research Integrity Policy & Guidance | National Institutes of Health (NIH)
- Federal Research Misconduct Policy | U.S. Department of Health & Human Services (HHS) - Office of Research Integrity (ORI)
V. Regulations
- Good Clinical Practice (GCP) Research Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials Sites | U.S. Food and Drug Administration (FDA)
- Society of Clinical Research Associates–sponsored FDA Clinical Trial Requirements Regulations, Compliance, and GCP Conferences | Society of Clinical Research Associates (SoCRA)
- Regulatory Documents | Ohio State University Center for Clinical and Translational Science
- First Clinical Research Laws, Regulations, and Guidelines Database | First Clinical Research Best Practices Journal
VI. Good Clinical Research Practices
Good Clinical Practice (GCP) training covers several topic areas related to ethical and scientific quality standards for designing, conducting, recording and reporting trials, to ensure compliance with GCP standards developed by various entities (i.e., International Code of Harmonisation [ICH] E6 GCP Guidance, Food and Drug Administration, Clinical Trials Transformation Initiative [CTTI], and TransCelerate BioPharma Inc.).
- FDA Regulations Related to GCP | U.S. Food and Drug Administration (FDA)
- ICH Guidelines: Good Clinical Practice (E6) | International Code of Harmonisation (ICH)
- GCP Guidelines, Training of Research Professionals, SOPs | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Clinical Oncology (JCO)
- GCP Research Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators | ASCO Exemplary Attributes Publication Series, JOP
- Achieving Exemplary Attributes with AccrualNet™ | ASCO Exemplary Attributes Publication Series, JOP
- International Compilation of Human Research Standards (2015 Edition) | U.S. Department of Health and Human Services (HHS) - Office for Human Research Protections (OHRP)
- Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- Part 2: Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- 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
- Good Clinical Practice and Federal Code of Regulations | Rare Disease Clinical Research Network
- Use of the National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual | JOP
- The NCI-ASCO Cancer Trial Accrual Symposium: Summary and Recommendations | JOP
- FDA Good Clinical Practice Questions and Answers Database | First Clinical Research Best Practices Journal
- Intro to GCP | Association of Clinical Research Professionals (ACRP)
- Ethics and Human Subject Protection: A Comprehensive Intro | ACRP
VII. Standard Operating Procedures (SOPs)
- Biospecimen SOPs | Radiation Therapy Oncology Group
- SOP Templates (On a wide range of topics) | Dana-Farber/Harvard Cancer Center
- Issues Surrounding Biospecimen Collection and Use in Clinical Trials | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Donating Tissue for Research: Patient and Provider Perspectives | ASCO Exemplary Attributes Publication Series, JOP
- Cancer Genomics: Conducting Exemplary Trials With Biospecimen and Biomarker | ASCO Exemplary Attributes Publication Series, JOP
- Something for Everyone: Standard Operating Procedure Products for the Investigative Site | Norman Goldfarb
- Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Clinical Oncology (JCO)
- Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- Part 2: Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- To view additional samples online, search in your web browser for: "clinical trial standard operating procedures"
VIII. Marketing Your Research Program
- Negotiating for Success: Navigating the Contracting Process for an Exemplary Research Program | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Part 2: Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
IX. Engaging Patients in Your Research Program
- Research Advocacy Network Tutorial Series for Advocate Education | Research Advocacy Network
- Involving Advocates in Research | Perlmutter et al. | Seminars in Oncology
- Cancer Research Advocacy: Past, Present, and Future | Perlmutter et al. | Cancer Research
- Advocacy Program Research Awareness Event Tool Kit for Community Cancer Centers | Research Advocacy Network
- Part 2: Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | Journal of Oncology Practice (JOP)
- Communities as Partners in Clinical Trials: Changing Research Practice and Policy | Education Network to Advance Cancer Clinical Trials
X. Accessing Clinical Trials
- ClinicalTrials.gov | A registry and results database of publicly and privately supported clinical studies of human participants conducted around the world | National Institutes of Health (NIH)
- Listing of Clinical Trial Registries | U.S. Department of Health & Human Services (HHS)
- NCI Community Oncology Research Program (NCORP) | National Cancer Institute (NCI)
- Lead Academic Partnering Sites (LAPS) | NCI
- National Clinical Trials Network | NCI
- NCI-Designated Cancer Centers | NCI
- U.S. Oncology