3/13/09
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
1/13/09
PM-412 Confidentiality of Research Protocols
1/5/09
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)
9/19/08
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)
6/27/08
SM-506 Documentation of Informed Consent
6/13/08
PM-416 Preparation for Study Closeout
5/22/08
PM-402 Conducting PI-Initiated Multi-center Trials
QA-712 Subject Protocol Registration
SM-501 Obtaining Informed Consent in Human Research Studies
5/14/08
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
4/10/08
PM-409 Regulatory Binder Management
3/26/08
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
2/25/08
QA-711 Eligibility Checklist
QA-712 Subject Protocol Registration
2/21/08
PM-413 CRF Compliance
SM-506 Documentation of Informed Consent
11/1/07
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