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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 10/1/14

 

Consent (CON) Policies

CON-100 (formerly SM-506):Informed Consent Process - Effective 10/1/14

 

Documentation (DOC) Policies

DOC-101 (formerly PM-417): Source Documentation Requirements -Effective 10/1/14


Education & Training (EDU) Policies

EDU-100 (formerly ET-203): Protocol Specific Training Requirements - Effective 10/1/14
EDU-105 (formerly QA-723): Training Requirements for New Overall Principal Investigators - Effective 10/1/14


Investigational Product (INV) Policies

INV-103 (formerly PM-406): Protocol Mandated Drug Taken at Home -Effective 10/1/14

Multi-Center Trial (MULTI) Policies

MULTI-100 (formerly PM-402): Conducting PI-Initiated Multi-Center Trials - Effective 10/1/14
MULTI-101: Training Requirements for DF/HCC Sponsors and New DF/HCC Sponsor Team Personnel of DF/HCC Multi-Center Trials -Effective 10/1/14


Research Conduct (RCO) Policies

RCO-202 (formerly PM-410): Research Personnel CVs and Licenses -Effective 10/1/14
RCO-203 (formerly PM-409): Managing Essential Regulatory Documents -Effective 10/1/14
          


Registration (REGIST) Policies

REGIST-101 (formerly QA-712 & QC-804): Subject Protocol Registration -Effective 10/1/14
REGIST-200 (formerly SS-301): Registration of Clinical Trials on ClinicalTrials.gov - Effective 10/1/14


Updated Guidance:
Guidance on Delegation of Tasks for Research Involving a Drug or Device - Effective 10/1/14

New Guidances:
Guidance on Good Eligibility Documentation Practices - Effective 10/1/14 
Regulatory File Checklist for NCI National Clinical Trials Network (NCTN) Program Trials - Effective 10/1/14