The resources listed below provide tools and information on effectively managing a research site, including the contracting and institutional review board processes and procedures. This list is not exhaustive and will be updated periodically. If you have suggestions, please email the Research Community Forum.

I. Study-Specific Protocols, Procedures, and Requirements
II. Contract Terms, Obligations, and Management
III. Institutional Review Board (IRB) Review Procedures
IV. Regulatory Files
V. Subject Records
VI. Monitoring by Sponsor/Contact Research Organization (CRO)
VII. Drug Accountability, Storage, Dispensing and Return
VIII. Lab Sample/Specimen Collection, Handling, Processing, Transporting
IX. Handling of Amendments and Revisions
X. Electronic Correspondence Standard Operating Procedures
XI. External Adverse Event Safety Reports
XII. Long Term Storage of Study Records and Materials
XIII. Study Termination (Close Out) Visit and Requirements

I. Study-Specific Protocols, Procedures, and Requirements

(e.g., Institutional Review Board requirements, screening, recruitment, enrolment, informed consent, confidentiality, data collection, data management and storage, documentation, adverse events, protocol deviations, monitoring, etc.)

• Working With Your Institutional Review Board | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
• Screening Practices | Ohio State University Center for Clinical and Translational Science

II. Contract Terms, Obligations, and Management

• Negotiating for Success: Navigating the Contracting Process for an Exemplary Research Program | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
• Standardized Contract Language (START Clauses for Streamlining Clinical Trial Contract Negotiations) | Standard Terms of Agreement for Research Trial (START) Clauses - National Cancer Institute (NCI)
• MAGI Model Clinical Trial Agreement | Model Agreements & Guidelines International (MAGI) Best Practice Standards
• MAGI Clinical Trial Agreement Handbook | MAGI Best Practice Standards

III. Institutional Review Board (IRB) Review Procedures

(e.g., processes, submissions, reviews, approvals, renewals, compliance documentation, etc.)

• Institutional Review Board Frequently Asked Questions | U.S. Food and Drug Administration (FDA)
• Working With Your Institutional Review Board | ASCO Exemplary Attributes Publication Series, Journal of Oncology Practice (JOP)
• The Central Institutional Review Board (CIRB): The Central Institutional Review Board (CIRB) is sponsored by the National Cancer Institute (NCI) in conjunction with the Department of Health and Human Services Office for Human Research Protections (OHRP). CIRB conducts full board review of Cooperative Group trials, reducing workload for the local IRB and speeding up trial implementation time | NCI

IV. Regulatory Files

• Human Research Regulations | Ohio State University Center for Clinical and Translational Science

V. Subject Records

(e.g., source documents, requirements/processes for accessing, maintaining, etc.)

• Data Management: Case Report/Record Forms (CRFS) and Source Documentation | Ohio State University Center for Clinical and Translational Science
• Standard Operating Procedure (SOP) for Good Clinical Practice (GCP) | Nova Southeastern University

VI. Monitoring by Sponsor/CRO

• Site Monitor Visits | Ohio State University Center for Clinical and Translational Science
• ASCO Research Program Quality Assessment Tool | ASCO
• ASCO Clinical Trial Workload Assessment Tool | ASCO
• Clinical Trial Assessment of Infrastructure Matrix Tool (CT-AIM) | National Cancer Institute (NCI) - AccrualNet™
• ReCAP: Clinical Trial Assessment of Infrastructure Matrix Tool to Improve the Quality of Research Conduct in the Community | Journal of Oncology Practice (JOP)

VII. Drug Accountability, Storage, Dispensing and Return

• Drug Accountability, Dispensation, and Storage | Ohio State University Center for Clinical and Translational Science
• Handling Investigation Drugs | Cancer Therapy Evaluation Program (CTEP) - National Cancer Institute (NCI)

VIII. Lab Sample/Specimen Collection, Handling, Processing, Transporting

• Code of Federal Regulations | U.S. Department of Health & Human Services (HHS) - Office for Human Research Protections (OHRP)
• Biospecimen SOPs | Radiation Therapy Oncology Group (RTOG)
• Research Use of Stored Data or Tissues, Operation of Biological Repositories | HHS - OHRP
• 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)

IX. Handling of Amendments and Revisions

• General Information and Instructions: Protocol and Information Amendments | Duke University
• Investigational New Drug Application: Protocol Amendments | ASCO
• 21 CFR 312.30 - Protocol Amendments | U.S. Government Printing Office

X. Electronic Correspondence Standard Operating Procedures

• Standard Operating Procedure (SOP) Electronic Correspondence (For correspondence with the Human Research Protections Office and General Clinical Research Center) | University of New Mexico (UNM)

XI. External Adverse Event Safety Reports

• Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events | U.S. Department of Health & Human Services (HHS)
• Common Terminology Criteria for Adverse Events (CTCAE) | National Cancer Institute (NCI)
• Guidelines for Investigators: Adverse Event Reporting Requirements | for 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 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, and NCI | NCI
• A Manual for Participants in Clinical Trials of Investigational Agents Sponsored by DCTC, NCI | National Cancer Institute

XII. Long Term Storage of Study Records and Materials

• Technical and Operations Best Practice: Biospecimen Collection, Processing, Storage, Retrieval, and Dissemination | National Cancer Institute (NCI): Office of Biorepositories and Biospecimen Research
• Archiving the Phenome: Clinical Records Deserve Long-term Preservation | Milton Corn, MD | Journal of the American Medical Informatics Association
• Association for Clinical Data Management (ACDM) Guidelines to Facilitate Production of a Data Handling Protocol | Association for Clinical Data Management
• Maintenance and Storage of Research Records | Ohio State University Center for Clinical and Translational Science
• 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

XIII. Study Termination (Close Out) Visit and Requirements

• Standard Operating Procedures for Study Termination (Close Out) Visit and Requirements | University of New Mexico (UNM)
• Standard Operating Procedure (SOP) Study Termination Visit | Duke University
• Close Out Monitoring Visit | University of Cincinnati