Resources are listed below for some of the administrative considerations for a research program, including site requirements and responsibilities, investigator and staff roles and responsibilities, budgeting and billing, and administrative best practices. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.
I. Mission and Values
II. Site Requirements and Responsibilities
III. Investigator Roles and Responsibilities
IV. Conflict of Interest
V. Scientific Misconduct Policies and Procedures
VI. Research Staff Roles, Responsibilities, and Management
VII. Minimum Training Requirements
VIII. Clinical Trial Operations/Processes
IX. Standard Operating Procedures
X. Drug Accountability, Storage, Dispensing and Return
XI. Electronic Medical Records Policies and Procedures
XII. Privacy
XIII. Budget Management and Billing
I. Research Program Mission and Values
Mission and values consider factors like research participation, selection of trials, research integrity, quality assurance, clinical trial navigators, minority/underserved populations, and clinical trial portfolio diversity.
- ASCO Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Seven Attributes of Exemplary Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, JOP
- Enhancing Clinical Trial Awareness and Outreach | ASCO Exemplary Attributes Publication Series, JOP
- Cost-Neutral Clinical Research Enterprise | ASCO Exemplary Attributes Publication Series, JOP
- Enhancing Oncologist Participation in Research | ASCO Exemplary Attributes Publication Series, JOP
- Implementing Clinical Trials: a review of the attributes of exemplary clinical trial sites | JOP
- Early-Phase Clinical Trials in the Community: Results from the National Cancer Institute Community Cancer Centers Program Early-Phase Working Group Baseline Assessment | JOP
- Identifying and Selecting a Clinical Trial for Your Practice | JOP
- Many additional resources are available through online searches (e.g., "mission statements research")
II. Investigative Site Requirements and Responsibilities
- Quality Assurance and Educational Standards for Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
III. Investigator Roles and Responsibilities
(e.g., investigators roles and responsibilities, oversight, qualifications, credentialing, training, licensure, physician engagement, multidisciplinary team involvement)
- Investigator Handbook | National Cancer Institute (NCI)
- Guidelines for Investigators: Adverse Event Reporting Requirements | NCI - Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP), Cancer Imaging Program (CIP), Division of Cancer Prevention (DCP), Investigational New Drugs (IND) and Investigational Device Exemptions (IDE)
- Clinical Investigator Responsibilities (Select investigator roles and responsibilities and practical advice on how to promote compliance in practice) | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Good Clinical Practice Guidelines, Training of Research Professionals, Standard Operating Procedures | ASCO Exemplary Attributes Publication Series, JOP
- GCP Research Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators | ASCO Exemplary Attributes Publication Series, JOP
- ASCO Policy Statement: Oversight of Clinical Research | ASCO Exemplary Attributes Publication Series, JOP
- Quality Assurance and Educational Standards for Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, JOP
- The Clinical Research Team | JOP
- 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
IV. Conflict of Interest in Research
- Financial Conflict of Interest Regulations | National Institutes of Health (NIH)
- Responsible Conduct of Research | Stanley Korenman, MD | U.S. Department of Health & Human Services (HHS) - Office of Research Integrity (ORI)
- Research with Integrity | Tumeo et al. | Cleveland State University
- To view additional resources online, search in your web browser for: "conflict of interest in research"
V. Scientific Misconduct Policies and Procedures
- Research Integrity Policy & Guidance | National Institutes of Health (NIH)
- Federal Research Misconduct Policy | U.S. Department of Health and Human Services (HHS) - Office of Research Integrity (ORI)
VI. Research Staff Roles, Responsibilities, and Management
(e.g., staff roles and responsibilities, oversight, qualifications, job descriptions, core competencies, training requirements and maintenance, credentialing, orientation, workload assessment, performance)
- ASCO Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Clinical Oncology (JCO)
- ASCO Clinical Trial Workload Assessment Tool | ASCO
- Seven Attributes of Exemplary Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, JCO
- Clinical Trials Nurse Competencies | Oncology Nursing Society (ONS)
- Society of Clinical Research Associates (SoCRA) Certification | SoCRA
- Basic Steps to Building a Research Program | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- GCP Research Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators | ASCO Exemplary Attributes Publication Series, JOP
- ASCO Policy Statement: Oversight of Clinical Research | ASCO Exemplary Attributes Publication Series, JCO
- Enhancing Oncologist Participation in Research | ASCO Exemplary Attributes Publication Series, JOP
- Implementing clinical trials: a review of the attributes of exemplary clinical trial sites | Journal of Oncology Practice
VII. Minimum Training Requirements and Training Resources
Good Clinical Practice Training
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 FDA and other entities (i.e., ICH E6 Guidance, U.S. Food and Drug Administration, Clinical Trials Transformation Initiative [CTTI], and Transcelerate BioPharma, Inc.)
- FDA Regulations Relating to Good Clinical Practice and Clinical Trials | U.S. Food and Drug Administration (FDA)
- ICH E6 GCP Guidance | International Council for Harmonisation (ICH)
- CTTI Recommendations for Good Clinical Practice Training for Investigators | Clinical Trials Transformation Initiative (CTTI)
- TransCelerate Minimum Criteria for GCP Investigator Site Personnel Training | TransCelerate BioPharma, Inc.
Training Resources
There are many organizations that offer training on clinical trials and good clinical practice. The list provides examples only, it does not indicate endorsement from ASCO.
- ASCO Fundamentals of Clinical Trials | ASCO University
- FDA Clinical Investigator Training Course | FDA
- Entities Providing GCP and Human Subjects Protection Training:
- FDA Regulations, Compliance, and GCP Conference | Co-sponsored by Society of Clinical Research Associates (SoCRA) and FDA
- CITI Training | Collaborative Institutional Training Initiative (CITI)
- Good Clinical Practice and Federal Code of Regulations | Rare Disease Clinical Research Network
- Oncology Clinical Trials Nursing Competencies | Oncology Nursing Society (ONS)
VIII. Clinical Trial Operations/Processes
(e.g., tips for managing multiple sponsors and trials; internal quality assurance program; external inspections, auditing, and monitoring; biospecimen research infrastructure; Protocol Review and Monitoring Committee)
- Guidelines for Auditing Clinical Trials | National Cancer Institute (NCI) Clinical Trials Monitoring Branch - National Clinical Trials Network (NCTN), Community Clinical Oncology Program (CCOP), and NCI Community Oncology Research Program (NCORP)
- Clinical Research Site Infrastructure and Efficiency | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Issues Surrounding Biospecimen Collection and Use in Clinical Trials | ASCO Exemplary Attributes Publication Series, JOP
- Cancer Genomics: Conducting Exemplary Trials with Biospecimen and Biomarkers | ASCO Exemplary Attributes Publication Series, JOP
- Donating Tissue for Research: Patient and Provider Perspectives | ASCO Exemplary Attributes Publication Series, JOP
- Quality Assurance and Educational Standards for Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, JOP
- 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
IX. Standard Operating Procedures (SOPs)
(e.g., preparing, maintaining, and training on SOPs)
- Biospecimen SOPs | Radiation Therapy Oncology Group (RTOG)
- Draft SOPs Documents | Dana-Farber/Harvard Cancer Center
- Issues with 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 Biomarkers | ASCO Exemplary Attributes Publication Series, JOP
- Standard Operating Procedure Products for the Investigative Site | Norman Goldfarb
- ASCO Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Clinical Oncology (JCO)
- 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.” | National Cancer Institute (NCI)
- To view additional resources online, search in your web browser for: "clinical trial standard operating procedures"
X. Drug Accountability, Storage, Dispensing and Return
- The Clinical Research Team: Delegation of Research Tasks | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- ASCO Minimum Standards and Exemplary Attributes of Clinical Trial Sites | ASCO Exemplary Attributes Publication Series, Journal of Clinical Oncology (JCO)
- Engaging Referring Physicians in the Clinical Trial Process | ASCO Exemplary Attributes Publication Series, JOP
XI. Electronic Medical Records Policies and Procedures
(e.g., requirements and processes)
- Health Information Privacy and Security: A 10 Step Plan | HealthIT.gov
XII. Privacy
(e.g., HIPAA, privacy, confidentiality, and compliance related to participants, trials, and sponsors)
- Health Information Privacy - The Privacy Rule | U.S. Department of Health and Human Services (HHS)
- HIPAA privacy rule and research | HHS
- HIPAA privacy rule and research | National Institutes of Health (NIH)
- Health Information Privacy and Security: A 10 Step Plan | HealthIT.gov
XIII. Budget Management and Billing
Financial Management of a Research Program
- Developing an Investigator Site Budget for Clinical Trials | The Center for Cancer Care and Research (TCCCR)
- Budget Design and Development | Ohio State University Center for Clinical and Translational Science
- Cost-Neutral Clinical Research Enterprise | ASCO Exemplary Attributes Publication Series, JOP
- Health Insurance Coverage and Clinical Trials | Cancer.net
- Taming the Billing Beast: How to better manage clinical trials budgets | University of Michigan Health System
- Managing Clinical Trials | University of Oxford
- How to Keep the Project on Budget | SAS Institute
- General Guidance Information | Society of Clinical Research Associates (SoCRA)
- General Guidance Information | U.S. Food and Drug Administration (FDA)
- Making Research Dollars Stretch for Community Practices | JOP
Research Patient Billing Procedures
- Insurance Coverage of Clinical Trials Toolkit | ASCO
- National Coverage Determination (NCD) for Routine Costs in Clinical Trial (310.1) | Centers for Medicare and Medicaid Services
- Resources on Insurance Coverage for Clinical Trial Participants | ASCO
- Medicare National Coverage Determination | Centers for Medicare & Medicaid Services
- Health Insurance Coverage and Clinical Trials | Cancer.net