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.)

II. Contract Terms, Obligations, and Management

III. Institutional Review Board (IRB) Review Procedures

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

IV. Regulatory Files

V. Subject Records

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

VI. Monitoring by Sponsor/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