DF/HCC Policy and Operation Library
DF/HCC Policies define the rules and requirements that govern the conduct of research.
DF/HCC operations describe standard processes followed by research personnel.
DF/HCC Policy Training
All DF/HCC research personnel must document training on DF/HCC policies using the DF/HCC Policy Training & Signature Record. Recommended: Research personnel should complete the Policy Requirements Comprehension Quiz to help test their knowledge on consortium requirements for research conduct.
Helpful Links
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| Auditing | Committees | Consent | Data Management | |
Documentation | Education & Training | Investigational Product | Monitoring | Multi-Center Trials | |
Registration | Research Conduct | Research Close Out |
Administration (ADM)
Committees (COM)
Consent (CON)
- DF/HCC Consent Form Templates
- Guidance on Documenting Informed Consent
- Informed Consent Documentation Template
- Using Consent Documents Posted to OncPro
- Short Form Consent
- DFCI Use of Remote Interpreter - Documentation Checklist
- Guidance for DFCI Research Staff: Using Adobe Sign for e-Consent
- Instructions for Research Involving Non-English-Speaking Participants
Data Management / Safety (DATA)
Operations
Education and Training (EDU)
Multi-Center Trials (MULTI)
Registration (REGIST)
- ODQ Feasibility and Activation Page
- ODQ Subject Registration Page
- ODQ ClinicalTrials.gov & CTRP Registration Page
- DF/HCC Quick Guide to ClinicalTrials.gov (e-Learning)
Research Conduct (RCO)
IND/IDE INFORMATION
- Requirement for DF/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 DF/HCC)
REGULATORY DOCUMENTATION
- E-Learning: Documenting Delegation of Authority (7 min)
- E-Learning: Protocol Staff Changes (15 min)
- DF/HCC Regulatory File - Required Document List
- Regulatory File Checklist for NCTN Trials
- Study Start-Up Checklist
- DF/HCC Delegation of Authority Log Template
- DF/HCC Policy Training and Signature Record
- DF/HCC Key: Delegation of Tasks for Clinical Research
- DF/HCC External Site Delegation of Authority Template
SAFETY AND EVENT REPORTING
- E-Learning: Investigator Review of IND Safety Reports (9 min)
- FAQ - IND Safety Report Review and Receipt Requirements
- IRB Adverse Event Reporting Policy
- IRB Deviation-Violation Reporting Policy
- NCI Common Toxicity Criteria for Adverse Events (CTCAE)
- IND and IDE Safety Reports