Internal

Research Policies & Standard Operating Procedures

Policies	Policy Number
Clinical Research
POLICY CR-001 Pricing Structure for Sponsored Clinical Research Studies	CR-001

 

Policies	Policy Number
General and Administrative
SOP ADM-001 Standard Ope rating Procedures	ADM-001
SOP ADM-002 Research Non-Colleague Access to LUMC	ADM-002
SOP ADM-003 Research Activities in LUMC and Epic	ADM-003
SOP ADM-004 Management of External Research Requests for LUMC Tissue	ADM-004
SOP ADM-005 Radiology for Research	ADM-005
Financial Management
SOP FIN-001 Coverage Analysis	FIN-001
SOP FIN-002 Interim - Releasing Unrelated Claims	FIN-002
SOP FIN-003 Research Billing and Claims Review	FIN-003
SOP FIN-004 Invoicing for Research Patient Care Costs	FIN-004
SOP FIN-005 Study Closeout and Closeout Checklist	FIN-005
SOP FIN-006 Industry Sponsored Clinical Trial Agreement Negotiation	FIN-006
SOP FIN-007 Industry Sponsor Invoicing	FIN-007
SOP FIN-008 Budget Development and Negotiation	FIN-008
SOP FIN-009 Invoicing for Research Non-Patient Care Costs	FIN-009
SOP FIN-009 Invoicing for Research Non-Patient Care Costs Invoice Template	FIN-009
SOP FIN-010 SSOM Salary on Industry Funded Trials	FIN-010
Patient Management
SOP PAT-001 Research Consent Forms in Epic	SOP PAT-001
SOP PAT-002 Associating Patients in Epic for Billing	SOP PAT-002
SOP PAT-003 Communication of Research-Paid Patient Care Services	SOP PAT-003
SOP PAT-004 Prior Authorization of Research	SOP PAT-004
SOP PAT-005 LUC requests for LUMC archived tissues	SOP PAT-005
SOP PAT-006 Management of study paid research related injury	SOP PAT-006
Protocol Management
SOP PRO Investigational Drug Policy Billing	PRO
SOP PRO-001 Investigational Device Storage and Accountability	PRO-001
SOP PRO-002 Investigational Device Exemption Applications	PRO-002
SOP PRO-003 Operational and Financial Assessment of Research	PRO-003
SOP PRO-004 External Monitor Access to Epic	PRO-004
SOP PRO-005 Management of Research Equipment in LUMC	PRO-005
SOP PRO-006 Research Specimen Transport	PRO-006
SOP PRO-007 Completing the Form FDA 1572	PRO-007
SOP PRO-008 IND Applications	PRO-008
SOP PRO-009 Surgical Specimens for Research	PRO-009
SOP PRO-010 ClinicalTrials.gov: Applicable Clinical Trials and Reporting Requirements	PRO-010
SOP PRO-011 Study Records in Epic	PRO-011
SOP PRO-012 External Database Procedures	PRO-012
SOP PRO-013 Linking Encounters in Epic	PRO-013
SOP PRO-014 Research Use of Financial Information	PRO-014
SOP PRO-015 Presenting or Publishing Clinical Case Reports Authorization for Use or Disclosure of Protected Health Information (PHI) For Publication Purposes	PRO-015
SOP PRO-016 Research Use of Clinical Data	PRO-016
SOP PRO-017 Equipment Provided to LUC	PRO-017
SOP PRO-018 Source Documentation and Case Report Forms	PRO-018
SOP PRO-019 Single patient IND (expanded access) including for emergency use  Single Patient IND, including Emergency Use, Drug and Biologic Informed Consent for Single Patient IND (Expanded Access), Including for Emergency Use Template and Instructions	PRO-019
SOP PRO-020 Informed Consent Process for Clinical Research	PRO-020
SOP PRO-021 FDA Inspection Preparation	PRO-021
SOP PRO-022 Unblinding in Clinical Research	PRO-022
SOP PRO-023 Initiating a clinical research study	PRO-023
Quality Management
QA-001 Quality Management Program	QA-001

 

Associated Documents and Forms	Policy Number
QA-001 Quality Review Checklist
Access Request Process for Colleagues and Non-Colleagues
Accounts Receivable Tracker (SOP #FIN-007)
Blood Collection for Research
Cover Letter for Routine Costs in Research
Coverage for Evidence Development (CED) Template
COVERAGE ANALYSIS: FREQUENTLY ASKED QUESTIONS AND OTHER HELPFUL TIPS
Glossary of Terms and Abbreviations
Guidance Sponsor Paid Procedure Communication
Industry Invoice Template
Investigator Tool – Device Log (SOP #PRO-001)
Request a Non-Colleague Workday Number
Non-Colleague ID Number Request Form
Request to Scan Document into Epic-Research
Study Patient List for Monitors
Cardiographics Department Research Fee Schedule
Cellular Therapy Laboratory Fee Schedule
Industry Funded Research Pharmacy Charges
Clinical Research Department Research Fee Schedule
Nuclear Medicine Department Research Fee Schedule
Pulmonary Diagnostics Department Research Fee Schedule
Radiology Department Research Fee Schedule
Revenue Integrity Research Fee Schedule