REGIST-200: Registration of Clinical Trials on ClinicalTrials.gov (Version 8)
|
DF/HCC Policy Tracked Changes
|
Apr 25, 2023
|
REGIST-101: Subject Registration (Version 15)
|
DF/HCC Policy Tracked Changes
|
Apr 25, 2023
|
INV-100: Research Pharmacy Standard Policy (Version 6)
|
DF/HCC Policy Tracked Changes
|
Apr 25, 2023
|
EDU-101 Version 5
|
|
Jun 2, 2023
|
HIPAA Authorization Form - Vietnamese
|
Resource
|
Oct 24, 2022
|
HIPAA Authorization Form - Russian
|
Resource
|
Jun 6, 2023
|
NCI Local Boilerplate Language
|
Resource
|
Jun 9, 2023
|
Non-Clinical Protocol Template
|
Template
|
Jun 9, 2023
|
Adverse Event Reporting
|
Policy
|
Jun 6, 2023
|
Biomedical Protocol Template
|
Template
|
Jun 9, 2023
|
RCO-203: Regulatory Documentation (Version 13)
|
DF/HCC Policy Tracked Changes
|
Jun 15, 2023
|
NMDP Consent Form Template
|
Template
|
Jun 9, 2023
|
Advarra Local Context Consent Language
|
Resource
|
May 22, 2023
|
tiny-pdf-sample
|
|
May 19, 2023
|
DFHCC Onboarding Webinar - 2023
|
Resource
|
May 24, 2023
|
REGIST-200: Registration of Trials on CT.gov
|
DF/HCC Policy
|
May 31, 2023
|
INV-100: Research Pharmacy Standard Policy
|
DF/HCC Policy
|
May 31, 2023
|
REGIST-101: Subject Registration
|
DF/HCC Policy
|
May 31, 2023
|
HIPAA - Investigator Representation for Research on Limited Data Sets of Protected Health Information
|
Form
|
Jul 9, 2015
|
2022-09-16 ORIC ICOI Pre-Submission Form Final
|
|
Sep 21, 2022
|
Abiraterone
|
Template
|
Jun 8, 2016
|
NCI Informational Brochure - Providing Your Tissue for Research - What You Need to Know
|
Form
|
Apr 11, 2017
|
Albanian Short Form Addendum
|
Form
|
Apr 11, 2017
|
Armenian Short Form Addendum
|
Form
|
Apr 11, 2017
|
Bengali Short Form Addendum
|
Form
|
Apr 11, 2017
|
Bosnian Short Form Addendum
|
Form
|
Nov 27, 2018
|
Arabic Short Form Addendum
|
Form
|
Apr 11, 2017
|
2019 Eligibility Checklist Example
|
|
Dec 7, 2018
|
2015 DFHCC Clinical Research
|
Resource
|
Jan 27, 2016
|
Chinese - Simplified Short Form Addendum
|
Form
|
Apr 11, 2017
|
Serbo-Croatian Short Form Addendum
|
Form
|
Apr 11, 2017
|
Spanish Short Form Addendum
|
Form
|
Apr 11, 2017
|
Tagalog Short Form Addendum
|
Form
|
Apr 11, 2017
|
Turkish Short Form Addendum
|
Form
|
Apr 11, 2017
|
Russian Short Form Addendum
|
Form
|
Apr 11, 2017
|
Somali Short Form Addendum
|
Form
|
Apr 11, 2017
|
Thai Short Form Addendum
|
Form
|
Apr 11, 2017
|
AUD-100: Audits and Inspections (Version 9)
|
DF/HCC Policy Tracked Changes
|
Jan 4, 2021
|
AUD-100: Audits and Inspections (Version 8)
|
DF/HCC Policy Tracked Changes
|
Jan 22, 2020
|
Cancer Care and Research at DF/HCC in 2015 (Presented by Barrett Rollins, MD, PhD on August 22, 2008)
|
Resource
|
Jun 25, 2015
|
Bicalutamide
|
Template
|
Jun 8, 2016
|
Bevacizumab
|
Template
|
Jun 8, 2016
|
Busulfan
|
Template
|
Jun 8, 2016
|
BIDMC Logging in to i RIS
|
|
Jul 17, 2019
|
BIDMC Logging in to i RIS
|
|
May 27, 2020
|
COM-OP-1: Maintenance of the OncPro Priority List (converted from ADM-102)
|
DF/HCC Operations
|
Apr 23, 2019
|
COM-OP-2: Accrual Monitoring and Scientific Review by the SRC
|
DF/HCC Operations
|
Jun 30, 2020
|
CON-100: Informed Consent Process (Version 11)
|
DF/HCC Policy Tracked Changes
|
Jan 4, 2021
|
CON-101: Obtaining Consent of Non-English Speakers
|
DF/HCC Policy
|
Aug 14, 2020
|
CTEP-IAM IDme Integration New Users PROD
|
|
Nov 21, 2022
|
Dacarbazine
|
Template
|
Jun 8, 2016
|
COVID NTF Extension June
|
|
Apr 27, 2020
|
Crizotinib
|
Template
|
Jun 8, 2016
|
Dactinomycin
|
Template
|
Jun 8, 2016
|
CTCAE v4.0 (Presented by Vicki Duvall and Michele Copersino on May 28, 2010)
|
Resource
|
Jun 25, 2015
|
CTCAE Version 4.0
|
Resource
|
Mar 16, 2017
|
CTEP-IAM IDme Integration for Existing Users
|
|
Jul 11, 2022
|
CTCAE Toxicity Codes version 5
|
|
Sep 10, 2018
|
Data Specimen Collection Protocol Template
|
Template
|
Jan 30, 2020
|
DATA-OP-9: Data Set Finalization and InForm eCRF Retirement (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-11: Post-Production Change Requests (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-10: InForm Ticket Support (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-5 InForm eCRF Development (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-6: Final eCRF Testing (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-7: Final CTRIO Testing (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-8: InForm Deployment (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
Delegation of Authority Template (revised version effective 9/1/21)
|
Template
|
Jul 13, 2021
|
DF/HCC Consent Template - Spanish Translation
|
Template
|
Jan 24, 2022
|
DF/HCC Contact List for External Audits and Regulatory Inspections
|
List
|
Feb 9, 2023
|
DFHCC Contacts for Clinicaltrials.gov Accounts and Initial Registration
|
|
Apr 11, 2023
|
DFHCC DSMC Toxicity Summary Template
|
|
Nov 5, 2021
|
Fludarabine
|
Template
|
Jun 8, 2016
|
Guidance for DFCI Research Staff - Using Adobe Sign for e-Consent
|
Guidance
|
Aug 23, 2021
|
Guidance - Adobe Sign Consent Message Language
|
Guidance
|
Nov 19, 2020
|
FAQs on Using Adobe Sign
|
Resource
|
Jan 5, 2023
|
FAQ - IND Safety Report Review and Receipt Requirements
|
Resource
|
Feb 23, 2022
|
Updated GCP Training Requirement: Guidance & FAQ (January, 2017)
|
Guidance
|
Jan 26, 2017
|
Guidance - Adobe Sign Consent Approved Message Language
|
Guidance
|
Sep 30, 2020
|
Glossary
|
Resource
|
Dec 8, 2016
|
HRP-410 - CHECKLIST - Waiver or Alteration of Consent Process
|
Resource
|
Nov 5, 2019
|
HRP-317 - WORKSHEET - Short Form of Consent Documentation
|
Resource
|
Nov 5, 2019
|
HRP-332 - WORKSHEET - NIH GDS Institutional Certfication
|
Resource
|
Nov 5, 2019
|
HRP-321 - WORKSHEET - Reportable New Information
|
Resource
|
Nov 5, 2019
|
HRP-323 - WORKSHEET - Criteria for Approval HUD
|
Resource
|
Nov 5, 2019
|
HRP-325 - WORKSHEET - Device Compassionate Use
|
Resource
|
Nov 5, 2019
|
HRP-314 - WORKSHEET - Criteria for Approval
|
Resource
|
Nov 5, 2019
|
HRP-330 - WORKSHEET - HIPAA Authorization
|
Resource
|
Nov 5, 2019
|
HRP-322 - WORKSHEET - Emergency Use
|
Resource
|
Nov 5, 2019
|
INV-101: Transfer of Investigational Drug
|
DF/HCC Policy
|
Jan 30, 2020
|
Investigator-Initiated Multi-Center Trials (Presented by Jeffrey Clark, MD on September 26, 2008)
|
Resource
|
Jun 25, 2015
|
INV-103: Protocol Mandated Drug Taken at Home (Version 9)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
Training: Investigator-Held IND Studies
|
Resource
|
Jun 25, 2015
|
INV-OP-1: Mandatory Research Pharmacy Standard Procedures
|
DF/HCC Operations
|
Nov 2, 2022
|
IRB Review Requirements for Secondary Use Research
|
Guidance
|
Aug 30, 2017
|
Procedures for Monitoring the Consent Process
|
Guidance
|
Jan 13, 2016
|
IRB Review of Data Safety Monitoring Plans
|
Guidance
|
May 31, 2019
|
MA State Law Involving Human Research
|
Guidance
|
May 24, 2017
|
Just in Time (JIT) Submissions
|
Guidance
|
Dec 14, 2018
|
Guidance on Requesting OHRS Verification for the Transfer of Data or Specimens
|
Guidance
|
Oct 21, 2019
|
Institutional Engagement
|
Guidance
|
Dec 5, 2017
|
Guidance on Medical Devices
|
Guidance
|
Nov 8, 2019
|
IS - Guidance - p360
|
Guidance
|
Jun 27, 2017
|
DFCI IRB Requirements Relating to the Honest Broker in Biobanking
|
Policy
|
Oct 24, 2017
|
Consenting Blind and Illiterate Participants
|
Policy
|
Aug 10, 2018
|
Blood Draws From Healthy Volunteers
|
Policy
|
Jan 13, 2016
|
DF/HCC FAQ - NIH sIRB Mandate
|
DF/HCC Policy
|
Dec 9, 2021
|
Drug Shortages
|
Policy
|
Jan 13, 2016
|
Mercaptopurine
|
Template
|
Jun 8, 2016
|
Mesna
|
Template
|
Jun 8, 2016
|
Mitoxantrone
|
Template
|
Jun 8, 2016
|
Methotrexate
|
Template
|
Jun 8, 2016
|
Leuprolide
|
Template
|
Jun 8, 2016
|
Melphalan
|
Template
|
Jun 8, 2016
|
Model Consent Language for DFHCC Multi-Center Protocols
|
|
Feb 7, 2019
|
Auditing and Monitoring Information Sheet for Multi-Center Trials
|
Guidance
|
Aug 10, 2022
|
MULTI-OP-1:Review and Approval Process for Investigator-Sponsored Multi-Center Trials
|
Track Changes
|
Dec 3, 2019
|
MULTI-OP-1:Review and Approval Process for Investigator-Sponsored Multi-Center Trials
|
DF/HCC Operations
|
Dec 3, 2019
|
Multi-Center Institutional Review Contacts
|
Resource
|
Jan 20, 2023
|
NCI CIRB PI Worksheet
|
Form
|
Sep 11, 2020
|
NCI CIRB - HIPAA and Reconsent FAQs
|
Guidance
|
Nov 11, 2020
|
MULTI-OP-1: Review and Approval Process for Investigator-Sponsored Multi-Center Trials
|
DF/HCC Operations
|
Feb 1, 2021
|
Protocol Registration Form
|
Form
|
Dec 18, 2018
|
RCL-100: Preparation for Site Close Out (Version 7)
|
DF/HCC Policy
|
Sep 30, 2022
|
Provisional IC Guidance v 5 2019-09-27
|
|
Nov 12, 2019
|
RCO-102: Responsibilities of Investigators (Version 7)
|
DF/HCC Policy Tracked Changes
|
Jul 13, 2021
|
RCO-102: Responsibilities of Investigators (Version 7)
|
DF/HCC Policy
|
Jul 13, 2021
|
RCO-103: Confidentiality and Secondary Use of Research Information
|
DF/HCC Policy
|
Sep 30, 2022
|
RCO-205: Reporting of Protocol Deviations, Exceptions, and Violations
|
DF/HCC Policy
|
Jan 30, 2019
|
RCO-OP-3: Performance of Protocol Specified Procedures at Non-DF/HCC Sites
|
Track Changes
|
Dec 3, 2019
|
RCO-OP-1: Documenting Delegation of Authority (version effective 9/1/21)
|
Track Changes
|
Jul 13, 2021
|
RCO-OP-3: Performance of Protocol Specified Procedures at Non-DF/HCC Sites
|
DF/HCC Operations
|
Dec 3, 2019
|
RCO-OP-1: Documenting Delegation of Authority (version effective 9/1/21)
|
DF/HCC Operations
|
Jul 13, 2021
|
RCO-OP-2: Completion of Form FDA 1572
|
Track Changes
|
Dec 3, 2019
|
RCO-OP-2: Completion of Form FDA 1572
|
DF/HCC Operations
|
Dec 3, 2019
|
RCO-OP-3: Performance of Protocol Specified Procedures at Non-DF/HCC Sites
|
DF/HCC Operations
|
Jan 30, 2020
|
RCO-OP-2: Completion of Form FDA 1572
|
DF/HCC Operations
|
Jan 30, 2020
|
Sample Joint Meeting Communication Record
|
Template
|
Mar 16, 2017
|
Note to File Template
|
Template
|
Mar 16, 2017
|
Albanian Short Form
|
Form
|
May 30, 2019
|
Armenian Short Form
|
Form
|
May 30, 2019
|
Bengali Short Form
|
Form
|
May 30, 2019
|
Amharic Short Form
|
Form
|
May 30, 2019
|
Self-Guided DFHCC Website Tour
|
Resource
|
Aug 18, 2022
|
Short Form Consent Form - Arabic
|
Form
|
May 30, 2019
|
European Portuguese Short Form
|
Form
|
May 30, 2019
|
Serbo-Croatian Short Form
|
Form
|
May 30, 2019
|
Romanian Short Form
|
Form
|
May 30, 2019
|
Punjabi Short Form
|
Form
|
Jan 22, 2021
|
Russian Short Form
|
Form
|
May 30, 2019
|
Tagalog Short Form
|
Form
|
May 30, 2019
|
Spanish Short Form
|
Form
|
May 30, 2019
|
Somali Short Form
|
Form
|
May 30, 2019
|
Workflow - Research on previously collected and banked samples sent to outside facility, including the Broad
|
Resource
|
May 29, 2018
|
Workflow - PI Initiated Clinical Trials where the correlative research is part of the IRB approved protocol
|
Resource
|
May 29, 2018
|
Work Instructions - Reviews - Performing Full Board IRB Reviews
|
|
Jun 27, 2019
|
Work Instructions - Reviews - Performing Expedited IRB Reviews
|
|
Jun 27, 2019
|
Work Instructions - Reviews - Performing Ancillary Reviews
|
|
Jun 27, 2019
|
Work Instructions - Reviews - Performing SRC Reviews
|
|
Jun 27, 2019
|
HIPAA - Investigator Representation for Review of Protected Health Information Preparatory to Research
|
Form
|
Jul 9, 2015
|
Brazilian Portuguese Short Form Addendum
|
Form
|
Apr 11, 2017
|
French - European Short Form Addendum
|
Form
|
Apr 11, 2017
|
European Portuguese Addendum
|
Form
|
Apr 11, 2017
|
Haitian Creole Short Form Addendum
|
Form
|
Apr 11, 2017
|
Consent Forms and Templates
|
Form
|
Apr 11, 2017
|
Bulgarian Short Form Addendum
|
Form
|
Apr 11, 2017
|
English Short Form Addendum
|
Form
|
Apr 11, 2017
|
German Short Form Addendum
|
Form
|
Oct 5, 2018
|
Greek Short Form Addendum
|
Form
|
Apr 11, 2017
|
Romanian Short Form Addendum
|
Form
|
Apr 11, 2017
|
Japanese Short Form Addendum
|
Form
|
Apr 11, 2017
|
Persian Short Form Addendum
|
Form
|
Jan 18, 2023
|
Polish Short Form Addendum
|
Form
|
Apr 11, 2017
|
Hebrew Short Form Addendum
|
Form
|
Apr 11, 2017
|
Korean Short Form Addendum
|
Form
|
Apr 11, 2017
|
Nepali Short Form Addendum
|
Form
|
Apr 11, 2017
|
Hindi Short Form Addendum
|
Form
|
Apr 11, 2017
|
Addendum - Italian
|
Form
|
Apr 11, 2017
|
ADM-100: Creation and Maintenance of DF/HCC Policies and Operations (Version 12)
|
DF/HCC Policy Tracked Changes
|
Sep 9, 2020
|
ADM-100: Creation and Maintenance of DF/HCC Policies and Operations (Version 12)
|
DF/HCC Policy
|
Sep 9, 2020
|
Asparaginase Erwinia
|
Template
|
Jun 8, 2016
|
Anastrozole
|
Template
|
Jun 8, 2016
|
ADM-OP-2: Maintenance of the AAHRPP Accreditation (converted from SOP ADM-103)
|
DF/HCC Operations
|
Apr 23, 2018
|
Adobe Sign Instructions for Research Participant
|
Resource
|
Sep 30, 2020
|
AUD-100: Audits and Inspections (Version 7)
|
DF/HCC Policy
|
Feb 1, 2021
|
Alert Page Process FAQ
|
Guidance
|
Jun 1, 2022
|
Benefits and Risks of Cancer Imaging (Presented by Jeffrey Yapp, PhD on February 19, 2010)
|
Resource
|
Jun 25, 2015
|
AUD-OP-2: FDA and Other Regulatory Inspections
|
Track Changes
|
Dec 3, 2019
|
AUD-OP-2: FDA and Other Regulatory Inspections
|
DF/HCC Operations
|
Dec 3, 2019
|
AUD-OP-1: Internal Auditing Procedures
|
Track Changes
|
Dec 3, 2019
|
AUD-OP-1: Internal Auditing Procedures
|
DF/HCC Operations
|
Dec 3, 2019
|
AUD-OP-2: FDA and Other Regulatory Inspections
|
DF/HCC Operations
|
Aug 10, 2022
|
Belmont Report
|
|
Jun 14, 2018
|
COM-OP-6: DSMB Procedures and Review
|
Track Changes
|
Dec 3, 2019
|
CON-100: Informed Consent Process
|
DF/HCC Policy
|
Feb 28, 2022
|
COM-OP-6 VERSION 1
|
|
Jan 30, 2020
|
CON-100 VERSION 8
|
|
Apr 2, 2018
|
CON-OP-1: Reconsent/Patient Notification Guide
|
Track Changes
|
Dec 3, 2019
|
CON-OP-1: Reconsent/Patient Notification Guide
|
DF/HCC Operations
|
Dec 3, 2019
|
CON-OP-1: Reconsent/Patient Notification Guide
|
DF/HCC Operations
|
Jan 30, 2020
|
DATA-101: Case Report Form Development (Version 8)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
DATA-101: Case Report Form (CRF) Design for PI-Initiated Protocols
|
DF/HCC Policy
|
Dec 31, 2015
|
Dexrazoxane
|
Template
|
Jun 8, 2016
|
HIPAA Authorization Form - Cape Verdean Creole
|
|
Oct 24, 2022
|
DFCI Use of Remote Interpreter - Documentation Checklist
|
Template
|
Feb 4, 2020
|
Local Context Survey
|
Resource
|
Dec 9, 2022
|
HIPAA Authorization Form - Chinese
|
|
Oct 24, 2022
|
DFHCC - HIPAA Authorization Form- ARABIC
|
|
Mar 9, 2022
|
DFHCC - HIPAA Authorization Form - ARABIC
|
|
Dec 9, 2021
|
DFHCC - HIPAA Authorization Form - CAPE VERDEAN CREOLE
|
|
Mar 9, 2022
|
DFHCC - HIPAA Authorization Form - CHINESE
|
|
Mar 9, 2022
|
DF/HCC Pre and Post Submission Checklist
|
List
|
May 26, 2021
|
DFHCC Protocol Review Requirements
|
Policy
|
Feb 25, 2023
|
Data and Safety Monitoring Board (DSMB) Charter
|
Policy
|
Mar 10, 2017
|
DSMB for Phase III Protocols Form
|
Form
|
Sep 18, 2018
|
Data Safety Monitoring Plan Template for Multi-Center Trials
|
Template
|
Mar 20, 2023
|
EDU-100: Training Requirements for Research Personnel
|
DF/HCC Policy
|
Feb 21, 2023
|
HIPAA Authorization Form - Cape Verdean Creole
|
Resource
|
Dec 9, 2021
|
HIPAA Authorization Form - Chinese
|
Resource
|
Dec 9, 2021
|
HIPAA Authorization Form - Haitian Creole
|
Resource
|
Dec 9, 2021
|
HIPAA Authorization Form - Portuguese
|
Resource
|
Dec 9, 2021
|
Health Stream Training Matrix
|
|
Apr 14, 2021
|
HIPAA Authorization Form - Arabic
|
Resource
|
Dec 9, 2021
|
HIPAA Authorization Form - Spanish
|
Resource
|
Dec 9, 2021
|
HIPAA Authorization Form - Vietnamese
|
Resource
|
Dec 9, 2021
|
How/When to Register a Protocol on CT.gov
|
Guidance
|
Apr 26, 2023
|
How/When to Submit Results to CT.gov
|
Guidance
|
Apr 23, 2018
|
When/How to Update a CT.gov Record
|
Guidance
|
Apr 26, 2023
|
HIPAA Authorization Form for NCI Studies
|
|
May 29, 2020
|
Health Stream Training Matrix
|
|
Nov 19, 2020
|
INV-100: Research Pharmacy Standard Policy (Version 5)
|
DF/HCC Policy Tracked Changes
|
Jan 4, 2021
|
Instructions for Accessing HSP and GCP Training Lists in On Core
|
|
May 9, 2018
|
Instructions - Reviewers - Full Board Procedures
|
|
Jun 27, 2019
|
INV-103: Protocol Mandated Drug Taken at Home
|
DF/HCC Policy
|
Sep 30, 2022
|
Guidance for Study Teams and Sponsors of Research: Information Regarding Approvable and Not-Approvable Language in Consent Forms
|
Guidance
|
Dec 9, 2021
|
Follow-On Submissions when Relying on an External IRB
|
Guidance
|
Dec 21, 2022
|
Institutional Certification Process for Genomic Data Sharing
|
Guidance
|
Sep 17, 2020
|
DFHCC Specimens and Data - External Sites Checklist
|
Guidance
|
Dec 11, 2018
|
DFCI IRB Approved Standard Drug Risk Language
|
Guidance
|
Mar 7, 2017
|
DFHCC FAQ - NIH sIRB Mandate
|
Guidance
|
Apr 3, 2023
|
Electronic Consent
|
Guidance
|
Aug 30, 2017
|
Use of the WCG IRB - FAQs
|
|
Jun 4, 2021
|
IS - Guidance - Follow-on Submissions when Relying on an External IRB
|
|
Dec 21, 2022
|
Using Consent Documents Posted to OncPro
|
Resource
|
Dec 15, 2020
|
Amendment - Request to Add/Remove a Site
|
Guidance
|
May 29, 2018
|
Reliance on the NCI CIRB: Investigator and DFCI IRB Responsibilities
|
Guidance
|
Aug 17, 2021
|
Expiration of IRB Approval and Administrative Closures
|
Policy
|
Jun 1, 2020
|
Guidance on the Priority List
|
Guidance
|
Jan 13, 2016
|
OncPro Guide
|
Guidance
|
Jun 6, 2017
|
IS - Operations - Guidance for Single IRB Review Process
|
|
Apr 3, 2023
|
IRB Resource for the Review of Data Specimen Collection Protocols
|
Resource
|
Oct 24, 2017
|
Successful Research Participation Communication
|
Resource
|
Jan 13, 2016
|
Massachusetts Law on Insurance Coverage
|
Resource
|
Jan 13, 2016
|
Criteria for IRB Approval of Research
|
Resource
|
Jan 13, 2016
|
Partners Recruitment of Subjects
|
Resource
|
Jan 13, 2016
|
Requirements for Informed Consent
|
Resource
|
Jan 23, 2019
|
Required Elements of Consent
|
Resource
|
Jan 12, 2018
|
NCI CIRB Local Context Boilerplate Consent Language
|
|
Oct 29, 2021
|
NCI CIRB Local Context Boilerplate Consent Language
|
|
May 29, 2020
|
Non-Therapeutic Office Hours Slides - 10.7.21
|
Resource
|
Mar 29, 2022
|
NCI CIRB Local Context Boilerplate Consent Language
|
|
Aug 18, 2021
|
ODQ Educational Session Q A Reference
|
|
Dec 21, 2016
|
NIH GCP Policy Reminder
|
|
Dec 21, 2016
|
RCL-100: Preparation for Site Close Out (Version 9)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
RCL-100: Preparation for Site Close Out (Version 8)
|
DF/HCC Policy Tracked Changes
|
Dec 3, 2019
|
RCL-101: Record Retention for Completed Research (Version 7)
|
DF/HCC Policy
|
Feb 28, 2022
|
RCL-OP-1: Procedures for Study Completion
|
Track Changes
|
Dec 3, 2019
|
RCL-OP-1: Procedures for Study Completion
|
DF/HCC Operations
|
Dec 3, 2019
|
RCL-OP-1: Study Completion Procedures
|
DF/HCC Operations
|
Jan 30, 2020
|
Note-to-File RCO-204 Version 12 Implementation
|
Resource
|
Dec 1, 2021
|
RCO-OP-1: Documenting Delegation of Authority
|
Track Changes
|
Dec 3, 2019
|
RCO-OP-1: Documenting Delegation of Authority
|
DF/HCC Operations
|
Dec 3, 2019
|
REGIST-101: Subject Registration (Version 13)
|
DF/HCC Policy Tracked Changes
|
Dec 3, 2019
|
REGIST-200: Registration of Clinical Trials on ClinicalTrials.gov (Version 7)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
Study Team Meeting Agenda
|
Template
|
Mar 16, 2017
|
Brazilian Portuguese Short Form
|
Form
|
May 30, 2019
|
NIH Implementation of the sIRB policy Q&A
|
Form
|
May 30, 2019
|
Japanese Short Form
|
Form
|
May 30, 2019
|
Persian Short Form
|
Form
|
Jan 18, 2023
|
Italian Short Form
|
Form
|
May 30, 2019
|
Hebrew Short Form
|
Form
|
May 30, 2019
|
Korean Short Form
|
Form
|
May 30, 2019
|
Nepali Short Form
|
Form
|
May 30, 2019
|
Polish Short Form
|
Form
|
May 30, 2019
|
Vinorelbine
|
Template
|
Jun 8, 2016
|
Workflow - Determination of Outside Site Engagement in Human Research Subject
|
Resource
|
May 29, 2018
|
Tacrolimus
|
Template
|
Jun 8, 2016
|
Thiotepa
|
Template
|
Jun 8, 2016
|
Topotecan
|
Template
|
Jun 8, 2016
|
Temozolomide
|
Template
|
Jun 8, 2016
|
Thioguanine
|
Template
|
Jun 8, 2016
|
WCG IRB Local Context Consent Language
|
Resource
|
Dec 9, 2021
|
ODQ Treatment Ended/Off Study Form
|
Form
|
Feb 23, 2023
|
Trastuzumab
|
Template
|
Jun 8, 2016
|
ADM-100: Creation and Maintenance of DF/HCC Policies and Operations (Version 12.1)
|
DF/HCC Policy Tracked Changes
|
Dec 1, 2021
|
ADM-100: Creation and Maintenance of DF/HCC Policies and Operations (Verision 10)
|
DF/HCC Policy Tracked Changes
|
Apr 27, 2018
|
Add Remove Site Form
|
|
Jun 19, 2018
|
COM-100: Research Oversight and Operational Committees (Version 11)
|
DF/HCC Policy Tracked Changes
|
Nov 15, 2022
|
COM-100: Research Oversight and Operations Committees (Version 10.1)
|
DF/HCC Policy Tracked Changes
|
Jan 7, 2021
|
COM-100: Research Oversight and Operational Committees (Version 10)
|
DF/HCC Policy Tracked Changes
|
Sep 9, 2020
|
COM-100: Research Oversight and Operational Committees (Version 10)
|
DF/HCC Policy
|
Sep 9, 2020
|
CON-100: Informed Consent Process (Version 12)
|
DF/HCC Policy Tracked Changes
|
Dec 1, 2021
|
CON-100: Informed Consent Process (Version 12)
|
DF/HCC Policy
|
Dec 1, 2021
|
DATA-100: Data Management of Investigator-Sponsored Therapeutic Protocols (Version 9)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
DATA-100: Data Management of Investigator-Sponsored Therapeutic Protocols (Version 8)
|
DF/HCC Policy Tracked Changes
|
Jul 13, 2021
|
DATA-100: Data Management of Investigator-Sponsored Therapeutic Protocols (Version 8)
|
DF/HCC Policy
|
Jul 13, 2021
|
DATA-100: Data Management of PI-Initiated Therapeutic Protocols
|
DF/HCC Policy
|
May 12, 2016
|
DATA-OP-4: Project Initiation Meeting (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-2: Obtaining Missing Forms Reports
|
DF/HCC Operations
|
Jan 31, 2019
|
DATA-OP-3: EDC Receipt (New)
|
DF/HCC Operations
|
Dec 10, 2018
|
DATA-OP-1: Data Requests
|
DF/HCC Operations
|
Jan 31, 2019
|
DF/HCC Checklist for Documenting Informed Consent Using a Remote Interpreter
|
Template
|
Dec 10, 2019
|
DF/HCC - List of RCR Site Codes, Labs, IRBs, Agent Shipment Form
|
Resource
|
Mar 22, 2023
|
HIPAA Authorization Form - Thai
|
Resource
|
Oct 24, 2022
|
Informed Consent Documentation Template
|
Template
|
Jan 25, 2022
|
DF/HCC Biospecimen Research Training
|
Resource
|
Feb 9, 2018
|
Guidance on Single IRB Review Process
|
Guidance
|
Apr 1, 2020
|
DFHCC Clinical Trials Gov Results Reporting Training
|
Resource
|
Jul 15, 2020
|
DFHCC - HIPAA Authorization Form - VIETNAMESE
|
|
Mar 9, 2022
|
DF/HCC Transfer of Obligations Template (NEW)
|
Template
|
Jan 4, 2022
|
DOC-100: Research Subject Documentation (Version 5)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
DOC-100: Subject Research Charts
|
DF/HCC Policy
|
Sep 30, 2022
|
DFHCC Website Guide CRS
|
Resource
|
Jun 30, 2015
|
Guidance for DF/HCC Regulatory Staff and IRB Reviewers on Cell Therapy ICFs
|
Guidance
|
Jul 27, 2022
|
Guidance for Leukapheresis Description and Risks for Cell Therapy Studies”
|
Guidance
|
Jul 27, 2022
|
Common Mistakes Found within CT.gov records
|
Guidance
|
Jan 24, 2023
|
OnCore Guidance: Registration Safety Mechanisms
|
Guidance
|
Jan 29, 2020
|
Guidance: How to Determine Primary Study Completion Dates
|
Guidance
|
Jan 24, 2023
|
Guidance on Documenting Informed Consent
|
Guidance
|
Sep 28, 2017
|
Guidance How To View Missing Forms Reports
|
|
Sep 14, 2018
|
HRP-310 - WORKSHEET - Human Research Determination
|
Resource
|
Nov 5, 2019
|
HRP-311 - WORKSHEET - Engagement Determination
|
Resource
|
Nov 5, 2019
|
HRP-313 - WORKSHEET - Expedited Review
|
Resource
|
Nov 5, 2019
|
HRP-312 - WORKSHEET - Exemption
|
Resource
|
Nov 5, 2019
|
HRP-307 - WORKSHEET - Devices
|
Resource
|
Nov 5, 2019
|
HRP-306 - WORKSHEET - Drugs
|
Resource
|
Nov 5, 2019
|
HIPAA Authorization Language for NCI Studies
|
|
May 29, 2020
|
How to Create and Update Alert Pages
|
|
Dec 2, 2022
|
IC Flowchart v 10 2019-11-08
|
|
Nov 8, 2019
|
Idarubicin
|
Template
|
Jun 8, 2016
|
Ifosfamide
|
Template
|
Jun 8, 2016
|
INDSR Office Hours 1.7 Slides
|
Resource
|
Jan 7, 2022
|
Insitutional Certification Request Form
|
|
Nov 12, 2019
|
IC Flowchart v 9 2019-10-30
|
|
Oct 30, 2019
|
Consent Form Guidance for Gene Transfer Studies
|
Guidance
|
Feb 8, 2017
|
Audio recording in Human Subjects Research
|
Guidance
|
Jul 13, 2017
|
Creating a Single IRB Platform Account
|
Guidance
|
Dec 20, 2022
|
Guidance on Patient Case Reports and When IRB and HIPAA Regulations Apply
|
Guidance
|
Jun 12, 2017
|
CLIA in the Research Context
|
Guidance
|
Jan 8, 2018
|
Guidance on the Transfer of Data or Specimens
|
Guidance
|
Jan 6, 2020
|
Guidance on the Transfer of Data or Specimens
|
Guidance
|
Jan 6, 2020
|
IS-Guidance on Data Transfer - 10.29
|
|
Nov 12, 2019
|
European Union General Data Protection Regulation (GDPR)
|
Guidance
|
Feb 15, 2019
|
The Use of Social Media in Recruitment to Research
|
Guidance
|
Sep 30, 2016
|
Completing the Nursing and Pharmacy Screening Form
|
Guidance
|
Jan 13, 2016
|
Continuing Review and the 2018 Common Rule
|
Guidance
|
Mar 14, 2019
|
Continuing Review and the 2018 Common Rule
|
Guidance
|
Nov 12, 2019
|
Guidance on Single IRB Review Processes
|
Guidance
|
Apr 3, 2023
|
IS - Index - Information Sheets
|
|
Aug 10, 2018
|
Sponsor Requests for PHI Related to Adverse or Severe Adverse Events
|
Policy
|
Jan 13, 2016
|
Additional Protections for Children
|
Resource
|
Jan 13, 2016
|
Short Form Translation Procedure
|
Policy
|
Sep 26, 2017
|
Subject Injury Language
|
Policy
|
May 2, 2023
|
Prisoners in Research
|
Policy
|
Jan 13, 2016
|
Sharing Protocols
|
Policy
|
Oct 11, 2017
|
Two Year Continuing Review
|
Policy
|
Jan 23, 2019
|
MON-101: Research Conduct Oversight by External Sponsors (Version 6)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
MON-101: Research Conduct Oversight by External Sponsors (Version 5)
|
DF/HCC Policy Tracked Changes
|
Dec 3, 2019
|
MULTI-100: Conducting DF/HCC Investigator-Sponsored Multi-Center Trials
|
DF/HCC Policy
|
Sep 30, 2022
|
OHRS Human Research Protection Training
|
Resource
|
Mar 8, 2017
|
OHRS Office Hours Top Ten Conditions - 6-22-2021
|
Resource
|
Mar 29, 2022
|
Office Hours 1.25.23 Slides
|
Resource
|
Jan 26, 2023
|
Office Hours 2.22.23 Slides
|
Resource
|
Mar 3, 2023
|
Office Hours September 21 2022 Slides
|
|
Sep 21, 2022
|
OHRS Office Hours Schedule
|
|
Jun 20, 2016
|
OHRS Omnipaque Shortage Process
|
Resource
|
May 13, 2022
|
RCL-101: Record Retention of Completed Research (Version 9)
|
DF/HCC Policy Tracked Changes
|
Dec 1, 2021
|
RCL-100: Preparation for Site Close Out (Version 9)
|
DF/HCC Policy
|
Dec 1, 2021
|
RCO-102: Responsibilities of Investigators
|
DF/HCC Policy
|
Aug 31, 2021
|
RCO-204: Safety and Event Reporting (Version 12)
|
DF/HCC Policy Tracked Changes
|
Dec 2, 2021
|
RCO-204: Safety and Event Reporting (Version 13)
|
DF/HCC Policy Tracked Changes
|
Sep 30, 2022
|
RCO-204: Safety and Event Reporting (Version 12)
|
DF/HCC Policy Tracked Changes
|
Jul 13, 2021
|
RCO-204: Safety and Event Reporting (Version 12)
|
DF/HCC Policy
|
Dec 2, 2021
|
RCO-204: Safety and Event Reporting (Version 12)
|
DF/HCC Policy
|
Jul 13, 2021
|
REGIST-101: Subject Registration (Version 14)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
REGIST-OP-1: Subject Registration Procedures (Version 3.14.23)
|
Track Changes
|
Mar 14, 2023
|
REGIST-OP-1: Subject Registration Procedures
|
Track Changes
|
May 7, 2020
|
DF/HCC Operation: REGIST-OP-4: NCI Clinical Trials Reporting Program (CTRP) Compliance
|
DF/HCC Operations
|
Jan 31, 2019
|
REGIST-OP-3: Eligibility Checklist Development
|
DF/HCC Operations
|
Mar 29, 2019
|
Regulatory Changes OHRS - Effective 012119
|
|
Jan 11, 2019
|
English Short Form
|
Form
|
May 9, 2019
|
Cambodian - Khmer Short Form
|
Form
|
Jul 15, 2019
|
French - European Short Form
|
Form
|
May 30, 2019
|
Haitian Creole Short Form
|
Form
|
May 30, 2019
|
Bulgarian Short Form
|
Form
|
May 30, 2019
|
Gujarati Short Form
|
Form
|
Jul 15, 2019
|
Bosnian Short Form
|
Form
|
May 30, 2019
|
German Short Form
|
Form
|
May 30, 2019
|
Greek Short Form
|
Form
|
May 30, 2019
|
Summary of Policy Updates - February 2022
|
Resource
|
Dec 1, 2021
|
What steps do I take before completing a study?
|
Resource
|
Feb 5, 2018
|
Subject Transfer Form
|
Form
|
Feb 23, 2023
|
Summary of Policy Updates Effective September 1 2021
|
Resource
|
Jul 13, 2021
|
Summary of Policy Updates September 2022
|
Resource
|
Aug 22, 2022
|
Summary of Policy Updates January 2023
|
Resource
|
Dec 2, 2022
|
Summary of Policy Updates May 2023
|
Resource
|
Apr 25, 2023
|
Subrecipient Application Checklist
|
|
Apr 23, 2018
|
IRB Policies and Procedures for the Protection of Human Subjects
|
|
Feb 25, 2020
|
Index of Approved Drug Language
|
List
|
Jun 8, 2016
|
1572 Related Policy Updates Tracking
|
|
Dec 3, 2019
|
1572 Policy Updates - Guidance FAQ
|
|
May 15, 2020
|
ADM-OP-1: Maintenance and Use of the DF/HCC Listserv (converted from SOP ADM-101
|
DF/HCC Operations
|
Apr 23, 2018
|
AUD-OP-1: Internal Auditing Procedures
|
DF/HCC Operations
|
Jan 30, 2020
|
NCI CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
|
Guidance
|
Sep 13, 2022
|
Step by Step Instructions - Using CITI to Complete HSP & GCP Training
|
Guidance
|
May 12, 2022
|
Clofarabine
|
Template
|
Jun 8, 2016
|
FDA Guidelines
|
Guidance
|
Jun 7, 2016
|
NCI CIRB Local Context Boilerplate Consent Language
|
Template
|
Nov 13, 2018
|
Capecitabine
|
Template
|
Jun 8, 2016
|
COM-100: Human Research Oversight and Operations Committees
|
DF/HCC Policy
|
Nov 15, 2022
|
COM-OP-5: Data and Safety Monitoring Committee (DSMC) Procedures, Review, and Data Compliance (revised version previously effective as of 4/27/21)
|
Track Changes
|
Jul 13, 2021
|
COM-OP-5: Data and Safety Monitoring Committee (DSMC) Procedures, Review, and Data Compliance (revised version previously effective as of 4/27/21)
|
DF/HCC Operations
|
Apr 27, 2021
|
COM-OP-5: DSMC Procedures, Review, and Data Submission Compliance
|
Track Changes
|
Dec 3, 2019
|
COM-OP-5: DSMC Procedures, Review, and Data Submission Compliance
|
DF/HCC Operations
|
Dec 3, 2019
|
COM-OP-2: Accrual Monitoring and Scientific Review by the SRC
|
Track Changes
|
Jun 30, 2020
|
COM-OP-6: DSMB Procedures and Review
|
DF/HCC Operations
|
Dec 3, 2019
|
COM-OP-6: Data and Safety Monitoring Board (DSMB) Procedures and Review
|
DF/HCC Operations
|
Jan 30, 2020
|
COVID-19 Note to File - Extension - September 2021
|
|
Jun 22, 2021
|
COVID Note to File January 2022
|
Resource
|
Jan 4, 2022
|
COVID-19 Note to File Extension June 2021
|
|
Dec 14, 2020
|
COVID-19 Note to File Extension December
|
|
Jul 31, 2020
|
COVID-19 Note to File Extension August
|
|
Jul 1, 2020
|
COVID-19 Note to File Extension July
|
|
May 29, 2020
|
COVID-19 NTF
|
|
Mar 23, 2020
|
HIPAA Authorization Form - Haitian Creole
|
Resource
|
Oct 24, 2022
|
HIPAA Authorization Form - Portuguese
|
Resource
|
Oct 24, 2022
|
HIPAA Authorization Form - Spanish
|
Resource
|
Nov 1, 2022
|
HIPAA Authorization Form - French
|
Resource
|
Oct 24, 2022
|
DFHCC - HIPAA Authorization Form - HAITIAN CREOLE
|
|
Mar 9, 2022
|
DFHCC - HIPAA Authorization Form - PORTUGESE
|
|
Mar 9, 2022
|
DFHCC - HIPAA Authorization Form - SPANISH
|
|
Mar 9, 2022
|
DFHCC - HIPAA Authorization Form - ENGLISH
|
|
Mar 9, 2022
|
DFHCC - HIPAA Authorization Form - POLISH
|
|
Mar 9, 2022
|
DF/HCC Guidance: Maximum Blood Draw for Research Purposes (new)
|
Guidance
|
Mar 11, 2021
|
DF/HCC Multi-Center Approval Requirements and Process
|
Guidance
|
Apr 24, 2023
|
DFHCC External Site Feasbility Questionnaire
|
|
Jan 30, 2018
|
EDU-100: Training Requirements for Research Personnel (Version 8)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
FAQs on Eligibility Checklist Development and Use
|
Resource
|
Apr 2, 2019
|
Etoposide
|
Template
|
Jun 8, 2016
|
External Site Subject Registration Form
|
|
Jun 23, 2022
|
Guidance on Responding to Audit Findings
|
Guidance
|
Nov 9, 2018
|
Guidance on Reviewing Protocol Departures and Developing Corrective Actions
|
Guidance
|
Dec 8, 2016
|
ClinicalTrials.gov Protocol and SAP Submission Process Overview - Guidance
|
Guidance
|
Aug 10, 2018
|
Guidance on Documenting Eligibility
|
Guidance
|
Feb 14, 2019
|
Guidance on Interactions with Monitors
|
Guidance
|
May 23, 2017
|
Good Study Documentation Practices
|
Guidance
|
Sep 28, 2017
|
Guidance Tool i RIS Pre-submission review for ICOI-New Application Mgmt when ICOI is identified-2
|
|
Sep 19, 2022
|
What are Source Documents?
|
Guidance
|
Mar 16, 2017
|
Guidance Tool i RIS Pre-submission Review for Institutional Conflict of Interest
|
|
Sep 19, 2022
|
HRP-419 - CHECKLIST - Waiver of Consent Process for Emergency Research
|
Resource
|
Nov 5, 2019
|
HRP-430 - CHECKLIST - Investigator Quality Improvement Assessment
|
Resource
|
Jul 17, 2020
|
HRP-411 - CHECKLIST - Waiver of Written Documentation of Consent
|
Resource
|
Nov 5, 2019
|
HRP-441 - CHECKLIST - HIPAA Waiver of Authorization
|
Resource
|
Nov 5, 2019
|
HRP-417 - CHECKLIST - Cognitively Impaired Adults
|
Resource
|
Nov 5, 2019
|
HRP-412 - CHECKLIST - Pregnant Women
|
Resource
|
Nov 5, 2019
|
HRP-416 - CHECKLIST - Children
|
Resource
|
Nov 5, 2019
|
HRP-415 - CHECKLIST - Prisoners
|
Resource
|
Nov 5, 2019
|
HRP-430 - CHECKLIST - Investigator Quality Improvement Assessment
|
|
Jul 17, 2020
|
IRB Policies and Procedures for the Protection of Human Subjects
|
Policy
|
Jul 13, 2020
|
Irinotecan
|
Template
|
Jun 8, 2016
|
iRIS Office Hours Slides - March 1 2022
|
Resource
|
Mar 3, 2022
|
i RIS Office Hours Slides - Alert Pages - May 19 2022
|
Resource
|
May 24, 2022
|
i RIS Study Teams
|
|
Dec 2, 2021
|
i RIS Committees
|
|
Jul 11, 2019
|
Research Funded or Supported by the Department of Defense
|
Guidance
|
Jan 13, 2016
|
Research Limited to the Use of Data or Specimens
|
Guidance
|
Oct 31, 2017
|
Research Procedures at External Sites
|
Guidance
|
Jun 4, 2018
|
Scientific Progress Review
|
Guidance
|
Apr 28, 2016
|
Relying on an External IRB
|
Guidance
|
Dec 21, 2022
|
IS - Guidance - Relying on an External IRB
|
|
Dec 21, 2022
|
Pregnant Partner Consent and Data Collection
|
Policy
|
Jun 2, 2021
|
NIH Updated Genomic Data Sharing Policy
|
Policy
|
May 29, 2018
|
Non-English Speaking Subject Consent Instructions
|
Policy
|
Oct 7, 2016
|
Legally Authorized Representatives
|
Policy
|
Nov 5, 2019
|
OHRS Information Sheet for Linked and Anonymous Specimens or Data
|
Resource
|
Oct 24, 2017
|
Implementing Dose Escalation
|
Policy
|
Jan 25, 2022
|
Outside Interest Disclosure
|
Policy
|
Jun 14, 2019
|
IND and IDE Safety Reports
|
Policy
|
Dec 1, 2017
|
MON-101: Research Conduct Oversight by External Sponsors
|
DF/HCC Policy
|
Sep 30, 2022
|
MULTI-100: DF/HCC Investigator-Sponsored Multi-Center Research (Version 13)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
MULTI-100: DF/HCC Investigator-Sponsored Multi-Center Research (Version 12)
|
DF/HCC Policy Tracked Changes
|
Dec 3, 2019
|
Pembrolizumab
|
Template
|
Oct 12, 2017
|
Considerations for Choosing among Types of Phase II Designs (Presented by Paul Catalano, ScD on July 23, 2010)
|
Resource
|
Jun 25, 2015
|
Pregnant Partner Consent Template
|
Template
|
Aug 26, 2020
|
Policy Training and Signature Record - January 2020 Update
|
|
Dec 17, 2019
|
Outside Interests Form
|
Form
|
Apr 21, 2021
|
Pre 2015 without consent Extramural IC Guidance v 4 2019-09-27
|
|
Nov 12, 2019
|
Pre 2015 with consent Extramural IC Guidance v 4 2019-09-27
|
|
Nov 12, 2019
|
Post 2015 Extramural IC Guidance v 4 2019-09-27
|
|
Nov 12, 2019
|
RCO-103: Confidentiality and Secondary Use of Research Information (Version 8)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
RCO-103:Confidentiality and Secondary Use of Research Information (Version 7)
|
DF/HCC Policy Tracked Changes
|
Dec 3, 2019
|
RCO-203: Research Subject Documentation (Version 11)
|
DF/HCC Policy Tracked Changes
|
Aug 22, 2022
|
RCO-203: Regulatory Documentation (Version 10)
|
DF/HCC Policy Tracked Changes
|
Dec 4, 2019
|
REGIST-100: Eligibility Checklists (Version 10)
|
DF/HCC Policy Tracked Changes
|
Jul 13, 2021
|
REGIST-100: Eligibility Checklists (Version 9)
|
DF/HCC Policy Tracked Changes
|
Dec 3, 2019
|
REGIST-100: Eligibility Checklists (Version 10)
|
DF/HCC Policy
|
Jul 13, 2021
|
REGIST-200: Registration of Clinical Trials on Clinicaltrials.gov (Version 7)
|
DF/HCC Policy Tracked Changes
|
Dec 3, 2019
|
REGIST-200
|
|
Jan 30, 2020
|
HIPAA - Request for Waiver or Alteration to Use or Disclose of Protected Health Information in Research
|
Form
|
Jul 9, 2015
|
Response Assessment Criteria for Clinical Trials (Presented by Cheryl Sadow, MD on January 29, 2008)
|
Resource
|
Jun 25, 2015
|
Requirement for DF/HCC Collaborations with Third Parties
|
Resource
|
Apr 22, 2021
|
Research Participant Adobe Sign Instructions
|
Resource
|
Nov 19, 2020
|
Regulatory File Checklist for NCTN Trials
|
List
|
May 24, 2017
|
Relying on External IRB workflow - pdf
|
|
Dec 21, 2022
|
Request to Rely Form
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Nov 13, 2019
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Research Funding Form
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Jun 12, 2018
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Vietnamese Short Form
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Form
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May 30, 2019
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Social and Behavioral Consent Template
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Template
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Mar 10, 2023
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Turkish Short Form
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Form
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May 30, 2019
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Telugu Short Form
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Form
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Jul 15, 2019
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SOP Training and Signature Record - January 2018 Update
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Log
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Dec 1, 2017
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Thai Short Form
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Form
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May 30, 2019
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NMDP IRB Consent Form Template
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May 29, 2020
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Site Detail Form
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Form
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Jan 12, 2016
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RCO-100: Investigator-Sponsored Research (Version 9)
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DF/HCC Policy Tracked Changes
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Jun 20, 2023
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RCO-100: Investigator-Sponsored Research (Version 9)
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DF/HCC Policy
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Jun 20, 2023
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Summary of Policy Updates August 2023
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Resource
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Jun 22, 2023
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Chinese - Traditional Short Form
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Form
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Jul 6, 2023
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Chinese - Simplified Short Form
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Form
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May 30, 2019
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Chinese - Traditional Short Form Addendum
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Form
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Jul 6, 2023
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Vietnamese Short Form Addendum
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Form
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Apr 11, 2017
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REGIST-OP-1: Subject Registration Procedures (Version 3.14.23)
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DF/HCC Operations
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Jul 21, 2023
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HIPAA - Investigator Representation for Research on Protected Health Information of Decedents
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Form
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Jul 9, 2015
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HIPAA - Investigator Representation for Research On De-Identified Protected Health Information
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Form
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Jul 9, 2015
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HIPAA Research Guidance Document
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Resource
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Jul 8, 2015
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NEW - RCO-104: New Protocol Submission Requirements (Version 1)
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DF/HCC Policy
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Jul 20, 2023
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RCO-204: Safety and Event Reporting
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DF/HCC Policy
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Sep 30, 2022
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EDU-100: Training Requirements for Research Personnel (Version 9)
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DF/HCC Policy Tracked Changes
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Feb 21, 2023
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RCO-203: Regulatory Documentation (Version 12)
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DF/HCC Policy Tracked Changes
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Dec 2, 2022
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ADM-100: Creation and Maintenance of DF/HCC Policies and Operations (Version 12.1)
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DF/HCC Policy
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Feb 28, 2022
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DSMC Monitoring Form for Phase I and High Risk Protocols
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Form
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Jul 27, 2023
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RCO-100: Investigator-Sponsored Research (Version 8)
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DF/HCC Policy Tracked Changes
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Sep 30, 2022
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DFHCC SOP Conversion Guide and Policy Operation Master List
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Resource
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May 16, 2018
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DF/HCC Office Hours Slides - July 2023 - RCO-104
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Resource
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Jul 28, 2023
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External Site Minor Log
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Log
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Jul 31, 2023
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Guidance on Data Sharing
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Apr 23, 2018
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PI Transfer Checklist (Guidance for PIs transferring into/out of DF/HCC)
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List
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Jul 21, 2023
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RCO-104: New Protocol Submission Requirements
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DF/HCC Policy
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Aug 1, 2023
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ABCs of GCPs (12:56)
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Resource
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Jun 26, 2015
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Alert Page
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Template
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Jul 11, 2019
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21 CFR Part 11 Letter-BIDMC
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Resource
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Jun 25, 2015
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DEA Letter-DFCI
|
Resource
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Jun 25, 2015
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DEA Letter-BIDMC
|
Resource
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Jul 9, 2015
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DEA Letter-MGH
|
Resource
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Jun 25, 2015
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Consent Template for Young Adult Who Has Reached Age 18
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Template
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Jan 12, 2016
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Biostats CRF Review Waiver
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Form
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Jan 27, 2017
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Consent Addendum Template
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Template
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Mar 10, 2023
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DATA-100: Data Management of PI-Initiated Therapeutic Protocols
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DF/HCC Policy
|
Jan 24, 2023
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DF/HCC Practice Differences in Comparison to ICH GCP Guidelines
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Resource
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Jun 25, 2015
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DF/HCC Delegation of Authority Log Template
|
Template
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Aug 31, 2021
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DF/HCC External Site Delegation of Authority Template
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Template
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Mar 30, 2023
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DF/HCC Key: Delegation of Tasks for Clinical Research
|
List
|
Apr 25, 2023
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DF/HCC Policy Training and Signature Record
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Log
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May 11, 2023
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DF/HCC Regulatory File (Reg Binder) Required Document List
|
List
|
Feb 3, 2020
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DF/HCC New Researcher Checklist (revised version previously posted)
|
List
|
Sep 7, 2023
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DF/HCC Consent Template
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Template
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Mar 10, 2023
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DF/HCC Data and Safety Monitoring Plan (DSMP)
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Policy
|
Nov 23, 2020
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Acceptance of Foreign Clinical Studies Not Conducted Under an IND - FAQ
|
Guidance
|
Jun 25, 2015
|
DF/HCC Site Management Plan
|
Resource
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Jan 12, 2023
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Guidance for IRBs, Clinical Investigators, and Sponsors - FDA Inspections of Clinical Investigators
|
Guidance
|
Jul 7, 2015
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IND Submission Checklist
|
List
|
May 24, 2017
|
IND Submission Letter
|
Template
|
May 24, 2017
|
Guidance on PI-Initiated, Externally-Sponsored Research
|
Guidance
|
Jan 20, 2017
|
Drug Diary Template - Multiple Drugs
|
Template
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Nov 4, 2022
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Drug Diary Template - Single Drug
|
Template
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Nov 4, 2022
|
Guidance on Creating a Study Drug Diary
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Guidance
|
Nov 4, 2022
|
IND Application
|
Template
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May 24, 2017
|
IRB Policies and Procedures for the Protection of Human Subjects
|
Policy
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Feb 12, 2023
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Statistical Guidelines for Non-Clinical Research Protocols
|
Guidance
|
Jan 13, 2016
|
Withdrawal of Consent to Continue in Research
|
Guidance
|
Oct 7, 2016
|
Return of Results Sample Consent Language
|
Guidance
|
Oct 7, 2016
|
Slides - iRIS Office Hours - Phase I Focus
|
Resource
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May 25, 2021
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Slides - iRIS Office Hours - April 29th, 2021
|
Resource
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Apr 29, 2021
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Slides - Tracking Submissions in iRIS: A Guide for Study Teams
|
Resource
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Jun 30, 2020
|
Return of Results
|
Guidance
|
Oct 7, 2016
|
Letter to CTSU (for NCI CTEP-Sponsored Studies)
|
Form
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Mar 29, 2023
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Sponsor Requests for PHI Related to Adverse or Severe Adverse Events
|
Guidance
|
Jun 25, 2015
|
New Project Application: Request for Exemption from IRB Review or Determination that Activity is Not Human Research
|
Policy
|
Jan 13, 2016
|
Quick Reference for New Protocol Submissions
|
Guidance
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Mar 18, 2019
|
Single Patient IND Policy
|
Policy
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Apr 1, 2020
|
Institutional Conflicts of Interest
|
Policy
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Jun 21, 2022
|
Frequently Asked Questions (FAQ)
|
Guidance
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Jan 13, 2016
|
Continued Participation
|
Policy
|
Jan 13, 2016
|
Overview of the DFCI IRBs
|
Resource
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Jul 17, 2017
|
Info Sheet - Use of Alert Pages
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Guidance
|
Jul 12, 2022
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Radiation Protocol Template
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Log
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Jan 12, 2016
|
Endorsement Form - Program Leader List
|
List
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Feb 6, 2023
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Pediatric Protocol Consent Template
|
Template
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Jan 30, 2020
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Slides - iRIS Office Hours - CTEP Amendment Update
|
Resource
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Feb 19, 2021
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Slides - iRIS Office Hours - Biosafety Reviews and General iRIS Q&A
|
Resource
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Mar 4, 2021
|
Slides: Operational Readiness at Activation
|
Resource
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Jun 26, 2020
|
List of Institutional IND Contacts
|
List
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May 23, 2017
|
Slides: Submission Routing
|
Resource
|
Jun 26, 2020
|
Letters for Sponsors
|
Resource
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Mar 29, 2023
|
DATA-101: Case Report Form Development
|
DF/HCC Policy
|
Sep 30, 2022
|
Protocol Screening Form for Research Nursing and Study Team
|
Form
|
May 4, 2018
|
RCO-203: Regulatory Documentation
|
DF/HCC Policy
|
Jun 15, 2023
|
Radiation Protocol Template
|
Template
|
Jan 30, 2020
|
Instructions for Documenting Delegation of Authority (RCO-OP-1)
|
DF/HCC Operations
|
Jun 23, 2022
|
RCO-OP-5: Obtaining and Maintaining an IDE
|
DF/HCC Operations
|
Jul 31, 2019
|
RCO-OP-4: Obtaining and Maintaining an IND
|
DF/HCC Operations
|
Jul 31, 2019
|
REGIST-100: Eligibility Checklists
|
DF/HCC Policy
|
Aug 31, 2021
|
New Project Application: Request for DFC IRB Approval of Recruitment of DFCI Patients and Clinicians for Research at Non DFHCC Institution
|
Form
|
Jan 12, 2016
|
Screening Consent Template
|
Template
|
Mar 10, 2023
|
Study Start-Up Checklist
|
|
May 16, 2018
|
Radiation Safety Protocol Screening
|
Form
|
Jun 6, 2018
|
Slides - iRIS Office Hours - Updated Feasibility Routing and iRIS Navigator
|
Resource
|
Jan 20, 2021
|
Single Patient IND Alert Page Template
|
Template
|
Jan 12, 2016
|
Withdrawal of Consent to Continue in Research
|
Template
|
Jan 12, 2016
|
Deviation Violation Exception and Other Event Reporting
|
Policy
|
Sep 14, 2023
|
RCO-100: Investigator-Sponsored Research (Version 7)
|
DF/HCC Policy
|
Sep 12, 2023
|