DF/HCC Site Management Plan

DF/HCC Practice Differences in Comparison to ICH GCP Guidelines

Letter from OHRS for Sponsors Outlining DFCI IRB Procedures

Direct questions to ohrs@dfci.harvard.edu.

BIDMC 21 CFR Part 11 letter
Partners 21 CFR Part 11 letter

Direct questions to jomol_mathew@dfci.harvard.edu.

BIDMC DEA
DFCI DEA
MGH DEA

Acronyms

Glossary

• ADM-100 (formerly GA-101): Writing and Revising DF/HCC Standard Operating Procedures
  • Helpful Resource: DF/HCC SOP Signature Page
  • Helpful Resource: DF/HCC SOP Template
  • Helpful Resource: Guidance on Format Requirements for Standard Operating Procedures (SOPs)

• ADM-101 (formerly GA-102): Use of the DF/HCC Research Listserv
• ADM-102 (formerly GA-103): Maintenance of the Oncology Protocol System (OncPro) Priority List
• ADM-103 (formerly QA-714): Maintenance of Association for the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation

• AUD-100 (formerly QA-720): Internal Auditing of Clinical Research
• AUD-101 (formerly QA-719): Audit Preparation and Response
  • Helpful Resource: Guidance on Hosting External Audits and Regulatory Agency Inspections
  • Helpful Resource: Guidance on Responding to Audit Findings

• AUD-102 (formerly QA-706): External Audits of DF/HCC Clinical Research
  • Helpful Resource: External Audit Contact List
  • Helpful Resource: Guidance on Hosting External Audits and Regulatory Agency Inspections
  • Helpful Resource: Sample IND/IDE Responsibility Checklist

• COM-100 (formerly QA-704): Responsibilities of the Clinical Research Operations Committee (CLINOPS)
• COM-101 (formerly QA-702): Responsibilities of the Audit Committee
• COM-102 (formerly QA-710): Responsibilities of the Scientific Progress Review Committee (SPRC)
• COM-103 (formerly QA-701): Responsibilities of the Clinical Investigations Leadership Committee (CLC)

• CON-100 (formerly SM-506):Informed Consent Process
  • Helpful Resource: Guidance on Documenting Informed Consent
  • Helpful Resource: Informed Consent Verification Checklist

• CON-101 (formerly SM-507): Obtaining Informed Consent of Non-English Speakers
• CON-102 (formerly SM-505): Use of Healthy Volunteers 
• CON-103 (formerly SS-306): Enrolling Subjects onto Secondary Studies Evaluating Research

• DATA-100 (formerly QA-717): Data Management of PI-Initiated Therapeutic Protocols
  
  • Helpful Resource: Protocol Data Request Form 
• DATA-101 (formerly QA-715): Case Report Form (CRF) Design for PI-Initiated Protocols  
  • Helpful Resource: QACT CRF Workflow
  • Helpful Resource: Biostatistics CRF Review Waiver

• DATA-102 (formerly PM-413): Case Report Form (CRF) Compliance for External Sponsors
• DATA-103 (formerly QA-716): Case Report Form (CRF) Submission Compliance for PI-Initiated Protocols
• DATA-104 (formerly QA-724): Data and Safety Monitoring Committee (DSMC) Data Submission Compliance

• DOC-100 (new): Subject Research Charts
• DOC-101 (formerly PM-417): Source Documentation Requirements
  • Helpful Resource: Guidance on Source Documents
  • Helpful Resource: Guidance on Good Study Documentation Practices

• DOC-102 (formerly PM-415): Note to File
  • Helpful Resource: Note to File Template

• EDU-100 (formerly ET-203): Protocol Specific Training Requirements
• EDU-101 (formerly ET-201): Standard Operating Procedure (SOP) Training Requirements
  • Helpful Resource: Role Matrix for Responsible Personnel

• EDU-102 (formerly ET-204): Human Subject Protection Training Requirements
• EDU-103 (formerly ET-205): Good Clinical Practice Training Requirements for New Researchers
• EDU-104 (formerly QA-722): Audit Training Requirements for New Clinical Researchers
• EDU-105 (formerly QA-723): Training Requirements for New Overall Principal Investigators

• INV-100 (formerly PM-403): Research Pharmacy Standard Procedures
• INV-101 (new): Transfer of Investigational Drug
• INV-102 (formerly PM-404): Return of Unused Investigational Drug from Subject to the Pharmacy
• INV-103 (formerly PM-406): Protocol Mandated Drug Taken at Home
  • Helpful Resource: Guidance on Creating a Drug Diary
  • Helpful Resource: Drug Diary Template - Multiple Drugs
  • Helpful Resource: Drug Diary Template - One Drug

• MON-100 (formerly QA-708): Monitoring Phase I Dose Escalation for PI-Initiated Protocols
  • Helpful Resource: OHRS Alert Page Template
  • Helpful Resource: OHRS Amendment Submission Form
  • Helpful Resource: In-House Phase I Clinical Trials Dose Escalation Form

• MON-101 (formerly QA-721): Routine Monitoring Visits by External Sponsors
  • Helpful Resource: Guidance on Investigator Interactions with Monitors

• MULTI-100 (formerly PM-402): Conducting PI-Initiated Multi-Center Trials
  • Helpful Resource: Multi-center Coordinating Center Checklist
  • Helpful Resource: Data and Safety Monitoring Plan Template
  • Helpful Resource: Multi-center Trials Forms, Guidance and Study Start-Up Tools
  • Helpful Resource: Participating Institution Regulatory Binder Instructions (for external sites)
  • Helpful Resource: Procedures for Submission of PI-Initiated Multi-center Protocols
  • Helpful Resource: Sponsor Regulatory File Checklist

• RCL-100 (formerly PM-416): Preparation for Site Close Out
  • Helpful Resource: Sample Research Close Out Checklist

• RCL-101 (formerly PM-401): Record Retention for Completed Research

• RCO-100 (formerly PM-408): Responsibilities of the Sponsor Conducting Research Involving a Drug
  • Helpful Resource: Form FDA 3500A (Mandatory MedWatch Form)
  • Helpful Resource: List of Institutional IND Contacts

• RCO-101 (formerly PM-418): Responsibilities of the Sponsor Conducting Research Involving a Device
• RCO-102: Responsibilities of Investigators
  • Helpful Resource: Guidance on Developing a Supervisory Plan for Clinical and Non-Clinical Research
  • Helpful Resource: Sample Joint Meeting Agenda
  • Helpful Resource: Sample Joint Meeting Communication Record
  • Helpful Resource: Supervisory Plan for Clinical and Non-Clinical Research

• RCO-103 (formerly PM-412): Confidentiality of Research Information
• RCO-200 (formerly ET-202): Documenting Delegation of Authority
  • Helpful Resource: Guidance on Delegation of Tasks for Research Involving a Drug or Device
  • Helpful Resource: Sample Group Delegation of Authority and Signature Log
  • Helpful Resource: Sample Individual Delegation of Authority and Signature Log

• RCO-201 (formerly PM-411): Completion of Form FDA 1572
• RCO-202 (formerly PM-410): Research Personnel CVs and Licenses
• RCO-203 (formerly PM-409): Managing Essential Regulatory Documents
  • Helpful Resource: Guidance on Maintaining Regulatory Documents
  • Helpful Resource: Master Regulatory File Checklist for Lead Site
  • Helpful Resource: Regulatory File Checklist for Network Affiliates
  • Helpful Resource: Regulatory File Checklist for Non-Lead and Satellite Sites
  • Helpful Resource: Sponsor Regulatory File Checklist

• RCO-204 (formerly AE-601): Reporting Adverse Events
  • Helpful Resource: DFCI IRB Serious Adverse Event Reporting Form
  • Helpful Resource: NCI Common Toxicity Criteria for Adverse Events (CTCAE)

• RCO-205 (formerly PM-407): Reporting of Protocol Deviations, Exceptions and Violations
  • Helpful Resource: DFCI IRB Major Deviation/Violation/Exception/Other Event Reporting Form
  • Helpful Resource: DFCI IRB Minor Deviation/Violation Log
  • Helpful Resource: Guidance on Reviewing Protocol Departures and Developing Corrective Actions

• RCO-206 (formerly PM-405): Overall Principal Investigator or Site Responsible Investigator Leave of Absence
• RCO-207 (formerly SM-502): Performance of Protocol Specified Procedures at Non-DF/HCC Sites

• REGIST-100 (formerly QA-711): Internal Eligibility Checklist   
• REGIST-101 (formerly QA-712 & QC-804): Subject Protocol Registration
• REGIST-102 (formerly SM-503): Notifying the QACT of Subject Removal from a Protocol
  • Helpful Resource: QACT Treatment Ended/Off Study Form

• REGIST-103 (formerly SM-504): Transfer of Subjects between Institutions
  • Helpful Resource: QACT Subject Transfer Form

• REGIST-200 (formerly SS-301): Registration of Clinical Trials on ClinicalTrials.gov
  • Helpful Resource: How/When to Register a Protocol on ClinicalTrials.gov (overview)
  • Helpful Resource: Step by Step Guidance for Registering a Protocol on ClinicalTrials.gov
  • Helpful Resource: How to Determine Primary Completion and Study Completion Date
  • Helpful Resource: Common Mistakes Found Within ClinicalTrials.gov Records
  • Helpful Resource: DF/HCC Contacts for ClinicalTrials.gov Accounts and Initial Registration

• REGIST-201 (formerly SS-307): Posting Results and Adverse Events on ClinicalTrials.gov   
  • Helpful Resource: How/When to Submit Results to ClinicalTrials.gov
  • Helpful Resource: Step by Step Guidance for Registering a Protocol on ClinicalTrials.gov
  • Helpful Resource: Common Mistakes Found Within ClinicalTrials.gov Records

• REGIST-202 (formerly SS-308): National Cancer Institute Clinical Trials Reporting Program (CTRP)   
• REGIST-300 (formerly QA-713): National Cancer Institute Investigator Registration
  • Helpful Resource: NCI Financial Disclosure Form (FDF)
  • Helpful Resource: NCI Statement of Investigator Form (Form FDA 1572)
  • Helpful Resource: NCI Supplemental Investigator Data Form (IDF)

• RSU-100 (formerly SS-302): Site Qualification Visit by External Sponsors   
• RSU-101 (formerly SS-303): Site Initiation Visit by External Sponsors
  • Helpful Resource: Sample Research Start-Up Checklist