HCC Policy and Operation Library

• Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) 

• ODQ Auditing Page

• HCC Data and Safety Monitoring Plan
• Guidance on the Priority List
• ODQ DSMC page

• HCC Consent Form Templates
• Guidance on Documenting Informed Consent
• Informed Consent Documentation Template
• Using Consent Documents Posted to OncPro
• HCC Use of Remote Interpreter - Documentation Checklist
• Guidance for DFCI Research Staff: Using Adobe Sign for e-Consent

OHRS - DFCI IRB Info Sheets & Resources 

• Policy - Instructions for Research Involving Non-English-Speaking Participants
• Policy - Use of Legally Authorized Representatives (LAR)
• Guidance - Reconsent Process & Notifying Participants of New Risks 
• Short Form Consents 

• ODQ Data Management Page
• RIO Support Overview Page
• RIO InForm Information Page 

• Guidance: What are Source Documents?
• Guidance: Good Study Documentation Practices
• Guidance: Documenting Eligibility 
• Guidance: Documenting Informed Consent
• Note to File Template

• HCC Education and Training Page
• New Research Staff Checklist (Training requirements, systems access, additional education modules)

• Guidance on Creating a Drug Diary

• Guidance on Investigator Interactions with Monitors

• ODQ Multi-Center Trial Page

• ODQ Feasibility and Activation Page
• ODQ Subject Registration Page 
• ODQ ClinicalTrials.gov & CTRP Registration Page
• HCC Quick Guide to ClinicalTrials.gov (e-Learning)

IND/IDE INFORMATION

• Requirement for HCC Collaborations with Third Parties
• Initial IND Submission Checklist
• Initial IND Submission Transmittal Letter
• Initial IND Application Template
• Form FDA 3500A (Mandatory MedWatch Form)
• List of Institutional IND Contacts 2016

INVESTIGATOR RESPONSIBILITIES

• E-Learning: Tips for Investigators: Activating a Protocol (6 min)
• E-Learning: Investigator Attestation and Outside Interests (8 min)
• PI Transfer Checklist (Guidance for PIs transferring into/out of HCC)

REGULATORY DOCUMENTATION

• E-Learning: Documenting Delegation of Authority (7 min)
• E-Learning: Protocol Staff Changes (15 min)
• HCC Regulatory File - Required Document List
• Regulatory File Checklist for NCTN Trials
• Study Start-Up Checklist
• HCC Delegation of Authority Log Template
• HCC Policy Training and Signature Record
• HCC Key: Delegation of Tasks for Clinical Research
• HCC External Site Delegation of Authority Template

SAFETY REPORTING

• E-Learning: Investigator Review of IND Safety Reports (9 min)
• FAQ - IND Safety Report Review and Receipt Requirements
• IRB Adverse Event & INDSR Reporting Policy
• NCI Common Toxicity Criteria for Adverse Events (CTCAE)

DEVIATION, VIOLATION, and OTHER EVENT REPORTING

• DFCI IRB Deviation, Violation and Exception Reporting Policy
• Guidance & Workflows: Recording Deviations & Violations in OnCore (OnCore WIKI)

OTHER

• Creating and Submitting a New Treatment Protocol page
• FDA Forms Search  
• Research Procedures at External Sites

• Study Completion Checklist
• Request ODQ Study Completion Signoff