Policy-Related Resources

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Consent	Source Documentation	Safety and Event Reporting
Investigator Responsibilities	IND/IDE Information	Research Close Out
Regulatory Documentation	Investigational Drug/Product

CONSENT

e-Learning - Writing a Consent Form Using DF/HCC Templates (40 mins)

SOURCE DOCUMENTATION

INVESTIGATIONAL DRUG/PRODUCT

INVESTIGATOR RESPONSIBILITIES

e-Learning - Tips for Investigators: Activating a Protocol (6 mins)

e-Learning - Investigator Attestation and Outside Interests (8 mins)

Related Policies and Operations

RCO-100: Investigator-Sponsored Research DF/HCC Policy
RCO-102: Responsibilities of Investigators DF/HCC Policy
RCO-103: Confidentiality and Secondary Use of Research Information DF/HCC Policy
RCO-104: New Protocol Submission Requirements DF/HCC Policy
RCO-203: Regulatory Documentation DF/HCC Policy
RCO-204: Safety and Event Reporting DF/HCC Policy
RCO-OP-1: Documenting Delegation of Authority DF/HCC Operations
RCO-OP-2: Completion of Form FDA 1572 DF/HCC Operations
RCO-OP-3: Performance of Protocol Specified Procedures at Non-DF/HCC Sites DF/HCC Operations

SAFETY AND EVENT REPORTING

e-Learning - Investigator Review of IND Safety Reports (9 mins)

IND/IDE INFORMATION

RCO-100: Investigator-Sponsored Research DF/HCC Policy
RCO-OP-4: Obtaining and Maintaining an IND DF/HCC Operations
RCO-OP-5: Obtaining and Maintaining an IDE DF/HCC Operations
Requirement for DF/HCC Collaborations with Third Parties Resource
Initial IND Submission Checklist List
Initial IND Submission Transmittal Letter Template
Initial IND Application Template Template
Form FDA 3500A (Mandatory MedWatch Form) Link
List of Institutional IND Contacts 2016 List

REGULATORY DOCUMENTATION

e-Learning - Documenting Delegation of Authority (7 mins)

e-Learning - Protocol Staff Changes (15 mins)

RESEARCH CLOSE OUT