These resources address the varied aspects of patient involvement in the clinical trial process. The resources cover topics including: eligibility and accrual, consent process, adverse event/serious adverse event reporting, and specimen protocols. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.
I. Patient Recruitment and Eligibility
II. Informed Consent Development, Implementation, and Documentation
III. Patient Management While on Study
IV. Patient Management While on Long-Term Follow-up
V. Adverse Event Reporting
VI. Specimen Collection, Handling, and Destruction
VII. Protocol Deviation Reporting and Prevention
VIII. Emergency Use of an Investigational Drug or Biologic Agent
I. Patient Recruitment and Eligibility
- Accrual Tool (Online tool with resources for recruiting and retaining participants to clinical trials) | National Cancer Institute - AccrualNet™
- PRE-ACT (Educational program designed to help patients better understand what clinical trials are and how they work; delivers clinical trial information through a series of short videos) | Prepatory Education About Clinical Trials (PRE-ACT)
- Patient Resources about Clinical Trials | Cancer.Net
- 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 National Cancer Institute Community Cancer Centers Program Screening and Accrual Log to Address Cancer Clinical Trial Accrual | Journal of Oncology Practice (JOP)
- The National Cancer Institute - American Society of Clinical Oncology Cancer Trial Accrual Symposium: Summary and Recommendations | JOP
II. Informed Consent Development, Implementation, and Documentation
- A Variety of Resources about Informed Consent | U.S. Department of Health & Human Services (HHS)
- Informed Consent | Ohio State University Center for Clinical and Translational Science
- Patient Perspective: Patient Safety and Informed Consent | Cancer.Net
III. Patient Management While on Study
(During treatment and protocol-specified shorter term follow-up)
- Accrual Tool (Online tool with resources for recruiting and retaining participants to clinical trials) | 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
IV. Patient Management While on Long-Term Follow-up
- Accrual Tool (Online tool with resources for recruiting and retaining participants to clinical trials) | 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
V. Adverse Event Reporting
- Common Terminology Criteria for Adverse Events (CTCAE) | National Cancer Institute (NCI)
- Guidelines for Investigators: Adverse Event Reporting Requirements For Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP), and Cancer Imaging Program (CIP), and Division of Cancer Prevention (DCP), Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs) | NCI
- Investigator Roles and Responsibilities (Provides practical advice on how to promote compliance in practice) | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Investigators' Handbook For Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI | NCI
- A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTC, NCI | NCI
VI. Specimen Collection, Handling, and Destruction
- Code of Federal Regulations | U.S. Department of Health & Human Services (HHS) - Office for Human Research Protections (OHRP)
- Research Use of Stored Data or Tissues, Operation of Biological Repositories | HHS - OHRP
- Biospecimen Standard Operating Procedures (SOPs) | Radiation Therapy Oncology Group (RTOG)
- Biospecimen Collection and Use in Clinical Trials | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
- Cancer Genomics: Conducting Exemplary Trials With Biospecimen and Biomarker Components | 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.” | National Cancer Institute (NCI)
VII. Protocol Deviation Reporting and Prevention
- Reporting Protocol Deviations | National Cancer Institute - Division of Cancer Prevention
- Noncompliance and Protocol Deviations | Yale University
- How to Avoid Protocol Deviations | University of Cincinnati
- FDA 21 CFR Parts 312 and 316 | U.S. Department of Health & Human Services (HHS) - Office for Human Research Protections (OHRP)
VIII. Emergency Use of an Investigational Drug or Biologic Agent
- Information Sheet: Treatment Use of Investigational Drugs | U.S. Food and Drug Administration (FDA)
- Investigational New Drug (IND) Application | FDA
- Emergency Single-Case Use of an Investigational Device, Drug or Biologic Product | Mayo Clinic Institutional Review Board (IRB)
- Investigational or Unlicensed Test Articles - Research with Drugs, Devices or Biologics | Stanford University









