Clinical Trials Management Office

Clinical Research Management Tool

Study Start-Up Checklist

Study Information
Study Acronym or Abbreviated Title
IRB #
Department
Principal Investigator
Sponsor Information
TRAINING
ITEM / COMPLETION DATE / SUPERVISOR DATE/INITIALS / COMMENTS
CITI Human Subjects / --/--/--
--/--/--
DOCUMENTS RECEIVED FROM SPONSOR
ITEM / COMPLETION DATE / SUPERVISOR DATE/INITIALS / COMMENTS
Confirm Receipt or creation of critical document:
Budget / --/--/--
Contract / --/--/--
Protocol / --/--/--
Draft Informed Consent / --/--/--
HIPAA Authorization / --/--/--
Investigator’s Brochure / --/--/--
Case Report Forms / --/--/--
Sponsor and Institutional Financial Disclosure Statements (FDS) / --/--/--
Advertisements / --/--/--
Handouts / --/--/--
Questionnaires / --/--/--
UNIT EVALUATION - FEASIBILITY
ITEM / COMPLETION DATE / SUPERVISOR DATE/INITIALS / COMMENTS
Assign a Primary Study Coordinator and Back-up. / --/--/-- / Primary:
Back-up:
Protocol is of interest
Resources are available to conduct the study successfully
Upon initial review, study is fiscally reasonable
Goals and requirements of the research unit are met / --/--/--
Complete Confidentiality Agreement (CDA) with Sponsor / --/--/--
Complete Sponsor Feasibility Assessments or other questionnaires / --/--/--
Contact other departments potentially involved
Conduct Site Qualification Visit with the sponsor / --/--/--
Complete the Feasibility Checklist (CTMO) / --/--/--
Contact Legal Affairs and CTMO for CTA Review / --/--/--
Create Internal Cost Assessment (ICA) / --/--/--
Create PRA / --/--/--
Obtain Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE) or Compassionate Use letter(s) and any supplemental correspondence from sponsor if applicable. / --/--/--
If conducting Investigator-Initiated Trials with Informed Consent Form (ICF) obtain;
Scientific review (2-3 reviewers),
Statistical review (as required),
Submit Investigational New Drug (IND) application (FDA Form 1571), IDE application or exemption to FDA as appropriate. / --/--/--
Organize Scientific Review Prior to IRB Submission / --/--/--
Complete COI Application Prior to IRB Submission / --/--/--
CLINICAL TRIALS MANAGEMENT OFFICE SUBMISSION
ITEM / COMPLETION DATE / SUPERVISOR DATE/INITIALS / COMMENTS
CTAs Signed / --/--/--
Protocol & ICF / --/--/--
CTMO Registration Form / --/--/--
Budget / --/--/--
PRA / --/--/--
--/--/--
INSTITUTIONAL REVIEW BOARD
ITEM / COMPLETION DATE / SUPERVISOR DATE/INITIALS / COMMENTS
New Study Application Form / --/--/--
Proposed ICF and HIPAA Authorization / --/--/--
Advertisements / --/--/--
Protocol and Investigator Brochure / --/--/--
Budget / --/--/--
Scientific Review Approval / --/--/--
Other Documents as Applicable / --/--/-- / List of Documents Submitted:
REGULATORY BINDER INFORMATION
ITEM / COMPLETION DATE / SUPERVISOR DATE/INITIALS / COMMENTS
FDA 1572 / --/--/--
Financial Disclosures / --/--/--
Curriculum Vitae / --/--/--
Medical and/or Nursing License / --/--/--
Protocol Signature Page / --/--/--
Approved Budget(s) / --/--/--
ICF/HIPAA Revision(s) / --/--/--
IRB Approved Consent Form / --/--/--
IRB Approval Letter(s) / --/--/--
Fully Executed Contract and W9 / --/--/--
Current Copy of IRB-Approved Protocol / --/--/--
IRB-Approved Advertisements, Diaries, Travel/Lodging Reimbursements, and Written Information Provided to Subjects / --/--/--
IRB Letter of Assurance (FWA) / --/--/--
Investigators Brochure / --/--/--
General Correspondence / --/--/--
IRB Application / --/--/--
FINAL APPROVAL
ITEMS / COMPLETION DATE / SUPERVISOR DATE/INITIALS / COMMENTS
Complete Regulatory Binder Set-up / --/--/--
Send finalized documents to the CTMO / --/--/--
Prepare Research Source Document / --/--/--
Obtain or create CRFs / --/--/--
Investigator(s) meeting / --/--/--
Investigator/Coordinators planning meeting / --/--/--
Identify and Request all necessary study supplies:
Study Drugs/Supplies / --/--/--
Laboratory Supplies / --/--/--
Disposables / --/--/--
Space / Furniture / --/--/--
Prepare New Patient Packets / --/--/--
If needed, Test Article shipped and arrangements confirmed / --/--/--
Site initiation visit complete / --/--/--