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Clinical Research Support

Clinical Research Unit (CRU)

Draft SOP Documents

Draft SOP Documents

Draft SOPs are documents DF/HCC will prospectively adopt on the indicated date.

Each document listed is being distributed for information purposes only. 

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

Highlights of DF/HCC Standard Operating Policy Revisions -Effective 3/1/14

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 -Effective 3/1/14
AUD-102 (formerly QA-706): External Audits of DF/HCC Clinical Research -Effective 3/1/14

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 -Effective 3/1/14
COM-102 (formerly QA-710): Accrual and Scientific Progress by the Scientific Review Committee -Effective 3/1/14
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 -Effective 3/1/14
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 -Effective 3/1/14

Documentation (DOC) Policies

DOC-100 (new): Subject Research Charts 
DOC-101 (formerly PM-417): Source Documentation Requirements -Effective 3/1/14
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 -Effective 3/1/14
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 -Effective 3/1/14
INV-101 (new): Transfer of Investigational Drug -Effective 3/1/14
INV-102 (formerly PM-404): Return of Unused Investigational Drug from Subject to the Pharmacy -Effective 3/1/14
INV-103 (formerly PM-406): Protocol Mandated Drug Taken at Home -Effective 3/1/14

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  -Effective 3/1/14        
           Research Closeout Checklist -Effective 3/1/14
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 -Effective 3/1/14
         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 -Effective 3/1/14
RCO-103 (formerly PM-412): Confidentiality of Research Information
RCO-200 (formerly ET-202): Documenting Delegation of Authority -Effective 3/1/14
          Guidance on Delegation of Tasks for Research Involving a Drug or Device
RCO-201 (formerly PM-411): Completion of Form FDA 1572 -Effective 3/1/14
RCO-202 (formerly PM-410): Research Personnel CVs and Licenses -Effective 3/1/14
RCO-203 (formerly PM-409): Managing Essential Regulatory Documents -Effective 3/1/14
          Master Regulatory File Checklist for Lead Site -Effective 3/1/14
          Regulatory File Checklist for Network Affiliates -Effective 3/1/14
          Regulatory File Checklist for Non-Lead and Satellite Sites -Effective 3/1/14
          Sponsor Regulatory File Checklist -Effective 3/1/14
RCO-204 (formerly AE-601): Reporting Adverse Events -Effective 3/1/14
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 -Effective 3/1/14
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