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Clinical Research Support

Clinical Research Unit (CRU)

Draft SOP Documents

Draft SOP Documents

Draft SOPs are documents DF/HCC will 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 4/30/15

DF/HCC Site Management Plan - Effective 4/30/15

Administrative (ADM) Policies

ADM-100 (formerly GA-101): Writing and Revising DF/HCC Standard Operating Procedures - Effective 4/30/15
ADM-101 (formerly GA-102): Use of the DF/HCC Research Listserv - Effective 4/30/15
ADM-103 (formerly QA-714): Maintenance of Association of the Accreditation of Human Research Protection Programs (AAHRPP) Accreditation - Effective 4/30/15

Audit (AUD) Policies

AUD-102 (formerly QA-706): External Audits of DF/HCC Clinical Research - Effective 4/30/15

Committee (COM) Policies

COM-100 (formerly QA-704): Responsibilities of the Clinical Research Operations Committee (CLINOPS) - Effective 4/30/15
COM-102 (formerly QA-710): Accrual and Scientific Progress by the Scientific Review Committee - Effective 4/30/15

Consent (CON) Policies

CON-100 (formerly SM-506): Informed Consent Process - Effective 4/30/15

Education & Training (EDU) Policies

EDU-102 (formerly ET-204): Human Subject Protection Training Requirements - Effective 4/30/15
EDU-103 (formerly ET-205): Good Clinical Practice Training Requirements for New Researchers - Effective 4/30/15
EDU-104 (formerly QA-722): Audit Training Requirements for New Clinical Researchers - Effective 4/30/15

Research Conduct (RCO) Policies

RCO-102 Responsibilities of Investigators - Effective 4/30/15
RCO-200 (formerly ET-202) Documenting Delegation of Authority - Effective 4/30/15
RCO-202 (formerly PM-410) Reserach Personnel CVs and Licenses - Effective 4/30/15  

Updated Guidances and Forms and Contacts:

Guidance on Delegation of Tasks for Research Involving a Drug or Device - Effective 4/30/15
External Audit Contacts
List of Institutional IND Contacts
New Drug Diary Template - Effective 4/30/15
Regulatory File Checklist for Network Affiliates - Effective 4/30/15