Standard Operating Procedures (SOPs)
Table of Contents
Section 100: General Administration
SOP 101: Standard Operating Procedures Preparation and Maintenance
A. Investigator SOP Template
B. Investigator SOP Training Documentation Form
SOP 102: Document Development and Change Control
A. Training Documentation Form
SOP 103: Investigator Responsibility and Delegation of Authority
A. Signature and Delegation of Authority Log
B. Form FDA 1571
C. Form FDA 1572
SOP 104: Study Team Training
A. Staff Training Form
B. Orientation Schedule for New Employees
C. SOP Review Sheet for New Employees
D. Protocol Self-Study Training Documentation
E. Internal SIV Training Documentation
SOP 105: Vendor Selection
SOP 106: Satellite Site Management Plan
SOP 107: Transfer of Principal Investigator Responsibilities
A. Template for Relinquishment of studies with a 1572
B. Template for Relinquishment of studies without a 1572
C. Memo to File template for studies temporarily suspended to accrual
Section 200: Regulatory Affairs
SOP 201: Contacts and Submissions for FDA
A. FDA Meeting Guidelines
B. IND Submission Checklist
C. Accessing FDA Forms over the Internet
D. IND Amendment Checklist
E. Medical Device Risk Determination Form
F. IDE Submission Checklist
G. IDE Supplement Checklist
SOP 202: Reporting Requirements for the FDA under an IND or IDE
A. IND Annual Report Guidelines
B. IDE Progress Report Guidelines
C. IDE Final Report Guidelines
D. FDA MedWatch Form 3500A
Section 300: Protocol Start-Up
SOP 301: Clinical Protocol Development, Implementation and Compliance
SOP 302: Clinical Protocol Amendments
Section 400: Study Start-Up
SOP 401: Initiation Visit
Section 500: Project Management
SOP 501: Communication
SOP 503: Documentation and Records Retention
A. Summary of ICH Essential Documents
B. DMS Medical Collections & Supply Order Form
C. DMS Medical Customer Care - Customer Order Form - Miami
D. Staff Instructions for Documenting Files for Recall America
SOP 504: Routine Monitoring Visits
SOP 505: Study Closeout
SOP 506: Study Suspension or Termination
Section 600: Subject Management
SOP 601: Informed Consent
A. Informed Consent Template
B. IRB Submission Checklist
C. Documentation of the Consenting Process Template
SOP 601.1: Obtaining and Documenting Informed Consent/Assent
A. Florida State Law for Surrogate Decision Makers for Health Care Treatment (website)
B. MHS Standard Practice Guidelines for Obtaining Consents for Elective and Emergency procedures
SOP 602: Subject Recruitment Practices
A. Guidelines for Recruitment and Advertising
SOP 603: Subject Screening and Enrollment
A. Subject Eligibility Checklist
B. Screening and Enrollment Log
SOP 604: Specimen Management
A. Specimen Preparation Checklist
B. Specimen Shipping Log
SOP 605: Adverse Event Recognition and Reporting
A. Serious Adverse Event Reporting Form
B. Adverse Event and Intercurrent Illness Log
C. Concomitant Medications Log
D. Reporting IND Safety Reports to the IRB
E. SAE Reporting Requirements Summary (Drug and Device)
F. FDA MedWatch Form 3500A
SOP 606: Maintenance of IND Safety Letters in e-format
SOP 607: Breaking the Blind
Section 700: Data Management
SOP 701: Case Report Forms
SOP 702: Clinical Research Data Management
SOP 703: Use of Electronic Data Systems
Section 800: Quality Assurance
SOP 801: Compliance and Monitoring Visits
A. CTN Best Practices Audit Checklist
B. CTNBP Monitoring Visit Checklist
C. CTNBP Study File Organization
D. CTSU Audit Education Slides
E. Monitoring Plan
SOP 802: FDA Inspection
Section 900: Miscellaneous
Pharmacy
SOP PH 10-10 Pharmacy Record Retention
SOP PH 75-01 Investigational Drugs
A. NCI DARF Investigational Agent Accountability Log (non-oral)
B. NCI DARF Oral Agent Accountability Log
C. Investigational Drug Transfer MTF
D. Satellite Pharmacy Transfer Record
SOP PH 75-02 lnvestigational Product Accountability Record Maintenance
A. NCI DARF Investigational Agent Accountability Log (non-oral)
B. NCI DARF Oral Agent Accountability Log
SOP PH 75-03 lnvestigational Drug Transfers between MHS Pharmacy and satellite sites
SOP PH 75-04 lnvestigational Drug Transfers between MHS facilities
