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Clinical Research Support

Quality Assurance Office for Clinical Trials (QACT)

Clinical Research List-serv

Archived Updates

Archived Updates

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fold faq Accrual Monitoring

New Methods of Accrual Monitoring (11/30/07)

fold faq Auditing

Audit Alert: Internal Audit Subject Selection Procedure (3/26/09)
Audit Manual Update (1/21/09)
Audit Alert: DF/HCC Initiated Multi-Center Trials: Informed Consent Documents
Audit Alert: Documenting Protocol Treatment Administration (9/26/08)
Audit Manual Update (2/26/08)

fold faq Clinical Investigations Leadership Committee

CLC Website (4/10/09)
Clinical Investigations Leadership Committee Announcement (12/4/08)

fold faq Clinical Research Unit

Clinical Research Operations becomes Clinical Research Unit (9/12/07)

fold faq Investigator Toolkit

Investigator Toolkit (8/13/08)

fold faq Laboratory Testing

Clinical Chemistry Laboratory at DFCI Testing (11/12/07)

fold faq NCI Clinical Trials Reporting Program

NCI Reporting Requirement (11/13/2008)
DF/HCC Clinical Trials Reporting Process (1/5/2009)
Clinical Trials Reporting Clarification (1/13/2009)

fold faq NCI Study Reminders

Study Reminders (1/2/08)

fold faq Other

Updated DFCI CLIA (10/27/08)

fold faq PI Inititated Multi-Center Trials

DF/HCC PI-Initiated Multi-Center Procedures (10/18/07)
Updated DSMP & Information for External Sponsors (5/22/08)

fold faq Protocol Registration

Emergency Protocol Registration Process (12/18/07)

fold faq Registration of Clinical Trials

Posting Basic Results to Clinicaltrials.gov (2/3/019)

FDA Amendment Regarding Changes to the Registration of Clinical Trials (12/19/07)

fold faq SOPs: Updated Policies

PM-411 Protocol Specific FDA 1572 Form
SM-502 Protocol Related Care for Study Subjects at a Non-DF/HCC Facility
QA-712 Subject Protocol Registration
QA-713 Centralized National Cancer Institute (NCI) Annual Investigator Registration

PM-412 Confidentiality of Research Protocols

QA-722 Audit Requirements for New Clinical Researchers
QA-723 Audit Requirements for New Overall Principal Investigators
PM-417 Source Documentation Requirements
SM-502 Protocol Related Care for Study Subjects at a Non-DF/HCC Facility
QA-710 Accrual Monitoring
             (tracked version)

PM-410 Procedure for Updating CVs & Medical Licenses
PM-411 Protocol Specific FDA 1572 Form
SM-502 Protocol Related Care for Study Subjects at a non-DF/HCC Facility
             (tracked version)

SM-506 Documentation of Informed Consent

PM-416 Preparation for Study Closeout

PM-402 Conducting PI-Initiated Multi-center Trials
QA-712 Subject Protocol Registration
SM-501 Obtaining Informed Consent in Human Research Studies

QA-708 Monitoring Phase I Dose Escalation for PI-initiated Trials
QA-709 Monitoring Phase II Early Stopping Rules for PI-initiated Trials
QA-716 Case Report Forms (CRF) Data Submission Compliance
QA-721 Policy for Routine Monitoring Visits by External Sponsors

PM-409 Regulatory Binder Management

PM-403 Research Pharmacy Standard Procedures
PM-404 Return of Unused Study Medications
PM-406 At Home Study Medication Compliance
SM-503 Notifying QACT of Subject Removal from a Protocol

QA-711 Eligibility Checklist
QA-712 Subject Protocol Registration

PM-413 CRF Compliance
SM-506 Documentation of Informed Consent

PM-401 Clinical Research Records Maintenance and Storage
QA-705 Responsibilities of the Audit Subcommittee
QA-706 Notifying DF/HCC of External Audits for Clinical Research
QA-713 Centralized NCI Annual Investigator Registration
QA-718 QACT Data Monitoring
QA-719 Audit Preparation and Response
QA-720 Internal Auditing of Clinical Trials

fold faq Templates

Correction to Biomedical Template (12/17/07)
Biomedical Protocol Template (9/21/07)