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.

II. Investigative Site Requirements and Responsibilities

III. Investigator Roles and Responsibilities

(e.g., investigators roles and responsibilities, oversight, qualifications, credentialing, training, licensure, physician engagement, multidisciplinary team involvement)

IV. Conflict of Interest in Research

V. Scientific Misconduct Policies and Procedures

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)

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.) 

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.

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)

IX. Standard Operating Procedures (SOPs)

(e.g., preparing, maintaining, and training on SOPs)

X. Drug Accountability, Storage, Dispensing and Return

XI. Electronic Medical Records Policies and Procedures

(e.g., requirements and processes)

XII. Privacy

(e.g., HIPAA, privacy, confidentiality, and compliance related to participants, trials, and sponsors)

XIII. Budget Management and Billing

Financial Management of a Research Program

Research Patient Billing Procedures