CTO course list - draft | UNCLCN Learning Portal

Standard Operating Procedure

SOP-1 SOP Administration	SOP-2 Amending CPO IITs	SOP-3 Determining IND Status & WI
SOP-4 Administrative Letters & WI	SOP-5 Action Letters, Parts A & B	SOP-6 OCT Audits
SOP-8 CTRP Initial Registrations	SOP-9 OnCore Subject ID Numbering	SOP-10 Subject Eligibility & WI
SOP-11 Drug Accountability & WI	SOP-12 Start Up Meetings	SOP-13 IND Safety Reporting, Parts A and B & WI
SOP-14 Research Charts	SOP-15 Adverse Events & WI	SOP-16 LCCC IND Updated FDA Form 1572 & WI
SOP-18 Study Specific Training & WI	SOP-20 Screening and Enrollment Logs & WI	SOP-21 Informed Consent & WI

Policies

Dress Code Policy

Time and Attendance Policy

Remote and Flex Work Policy

Conference Travel and Attendance Policy

Professional Certification and Membership Support for Clinical Trial Office

Professional Development Policy

Holiday Coverage Policy

Guidance for Investigator Notifications by Sponsors for External Safety Reports

Radiology Core Services Policy

Engagement in Research Assessment

IRB Approval of Study Personnel

Hybrid Decentralized Clinical Trials Task Logs

Policy on Form FDA 1572 Section #6

Essential Regulatory Records for Clinical Research Studies

Lost to Follow-Up Policy

LCCC Single Subject Exceptions

Monitoring Plan

Sponsor Escalation Plan Policy

Multicenter IIT Escalation Process

Clinical Data Management Plan

LCCC CTO Quality Management Plan

Institutional Data Safety and Monitoring Plan (DSMP)

Regulatory Mentor and Mentee Expectation Policy

LCCC Clinical Research Position Request Policy

CTO Offboarding Leadership Work Instructions

CTO Offboarding Permanent and Contract Staff Work Instructions

LCCC CTO Recruitment & Advertising Policy

LCCC CTO Investigator Engagement in Personnel Management Policy

CTO Hiring Policy