Draft SOPs are documents DF/HCC will prospectively adopt on the indicated date. The entries below become effective on September 17, 2012.

Each document listed is being distributed for information purposes only. All members of the research community, including investigators, are required to read and acknowledge review of all policies for which their role is listed as "Responsible Personnel." Please complete this requirement before September 17th.

Use the attached Role Matrix to (1) determine which SOPs are applicable to your role and (2) document your review of the SOPs. Forward a copy of the completed form to your institutional clinical trials office (if applicable).

Role Matrix for Responsible Personnel - Word format
Role Matrix for Responsible Personnel - PDF format for electronic signature
         Guidance on PDF Files & Electronic Signatures

 

Administration (ADM) Policies

ADM-100 (formerly GA-101): Writing and Revising DF/HCC Standard Operating Procedures
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

Audit (AUD) Policies

AUD-100 (formerly QA-720): Internal Auditing of Clinical Research
AUD-101 (formerly QA-719): Audit Preparation and Response
AUD-102 (formerly QA-706): External Audits of DF/HCC Clinical Research

Committee (COM) Policies

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) -Updated 4/4/13
COM-103 (formerly QA-701): Responsibilities of the Clinical Investigations Leadership Committee (CLC)

Consent (CON) Policies

CON-100 (formerly SM-506):Informed Consent Process
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 Management (DATA) Policies

DATA-100 (formerly QA-717): Data Management of PI-Initiated Therapeutic Protocols
DATA-101 (formerly QA-715): Case Report Form (CRF) Design for PI-Initiated Protocols
DATA-102 (formerly PM-413): Case Report Form (CRF) Compliance for External Sponsors
DATA-103 (formerly QA-706): Case Report Form (CRF) Submission Compliance for PI-Initiated Protocols
DATA-104 (formerly QA-724): Data and Safety Monitoring Committee (DSMC) Data Submission Compliance

Documentation (DOC) Policies

DOC-100 (new): Subject Research Charts
DOC-101 (formerly PM-417): Source Documentation Requirements
DOC-102 (formerly PM-415): Note to File

Education & Training (EDU) Policies

EDU-100 (formerly ET-203): Protocol Specific Training Requirements
EDU-101 (formerly ET-201): Standard Operating Procedure (SOP) Training Requirements
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

Investigational Product (INV) Policies

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

Monitoring (MON) Policies

MON-100 (formerly QA-708): Monitoring Phase I Dose Escalation for PI-Initiated Protocols
MON-101 (formerly QA-721): Routine Monitoring Visits by External Sponsors

Multi-Center Trial (MULTI) Policies

MULTI-100 (formerly PM-402): Conducting PI-Initiated Multi-Center Trials

Research Close Out (RCL) Policies

RCL-100 (formerly PM-416): Preparation for Site Close Out
RCL-101 (formerly PM-401): Record Retention for Completed Research

Research Conduct (RCO) Policies

RCO-100 (formerly PM-408): Responsibilities of the Sponsor Conducting Research Involving a Drug
RCO-101 (formerly PM-418): Responsibilities of the Sponsor Conducting Research Involving a Device
RCO-102 (new): Responsibilities of Investigators
          Guidance on Developing a Supervisory Plan for Clinical and Non-Clinical Research
          Sample Joint Meeting Agenda
          Sample Joint Meeting Communication Record
          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
          Guidance on Delegation of Tasks for Research Involving a Drug or Device
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
          Master Regulatory File Checklist for Lead Site
          Regulatory File Checklist for Network Affiliates
          Regulatory File Checklist for Non-Lead and Satellite Sites
          Sponsor Regulatory File Checklist
RCO-204 (formerly AE-601): Reporting Adverse Events
RCO-205 (formerly PM-407): Reporting of Protocol Deviations, Exceptions and Violations
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

Registration (REGIST) Policies

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
REGIST-103 (formerly SM-504): Transfer of Subjects between Institutions

REGIST-200 (formerly SS-301): Registration of Clinical Trials on ClinicalTrials.gov
REGIST-201 (formerly SS-307): Posting Results and Adverse Events on ClinicalTrials.gov
REGIST-202 (formerly SS-308): National Cancer Institute Clinical Trials Reporting Program (CTRP)

REGIST-300 (formerly QA-713): National Cancer Institute Investigator Registration

Research Start-Up (RSU) Policies

RSU-100 (formerly SS-302): Site Qualification Visit by External Sponsors
RSU-101 (formerly SS-303): Site Initiation Visit by External Sponsors