Clinical Research Toolbox

• ALCOA+C Documentation (PDF)
• Clinical Research Acronyms (PDF)
• Clinical Research Professional Certification Packet (PDF)
• Clinical Trial Agreement (CTA) Process (PDF)
• Contract Definitions (PDF)
• CRC Cores Diagram (PDF)
• CRC Services
• Investigator Training Outline (PDF)
• Reliant IRB Glossary of Terms (PDF)
• PHI-18 Identifiers Flyer (PDF)
• REDCap Introduction (PDF)
• Research Billing Patient Visit Flowchart (PDF)
• Supporting UH Research through Social Media (PDF)

• Regulatory Binder Files Index (PDF)
• Regulatory Binder Template and Tabs (PDF)
• Internal Adverse Event Summary log (Excel .xls)
• External Adverse Event Summary log (Excel .xls)
• Corrective and Preventative Action Plan (Word .doc)
• Delegation of Authority Log/Staff Signature Log (Word .doc) (2/2019)
• Device Accountability Log (Word .doc)
• Drug Accountability Log (Word .doc)
• Monitoring Log (Word .doc)
• Note to File Template (Word .doc)
• Protocol Deviations Log (Word .doc)
• Screening/Enrollment Log (Word .doc)
• Training Log (Word .doc)
• Training Log Signature Sheet (PDF)
• Training Log Signature Sheet (Word .doc)
• Certified Copy Attestation (PDF)
• Electronic Certified Copy Attestation (PDF)
• Records Retention Table (PDF)
• Iron Mountain Note to File (PDF)
• Iron Mountain Process Checklist (PDF)
• Iron Mountain Process Checklist using ONCORE (PDF)

• Chart Review Checklist (PDF)
• ClinicalTrials.gov – Create an Account (PDF)
• ClinicalTrials.gov – Register a Clinical Trial (PDF)
• Internal Study Handoff/Transfer Report (DOC)
• Site Initiation Visit Checklist (DOC)
• Site Initiation Visit Agenda (PDF)
• Site Initiation Visit FAQs (DOC)
• Site Initiation Visit Slide Presentation Template (PPTX)
• Site Initiation Tip Sheet (PDF)
• UH-Researcher-Cold-Storage-Reference (PDF)
• Versions in Clinical Research Tip Sheet (PDF)

• Authorization for Release of Medical Information (PDF)
• Alternative Wording for Consent Documents (PDF)
• Building an eConsent Documentation Tool in REDCap (PDF)
• Concomitant Medications (Con-Med) Log Template (XLSX)
• Consenting Non-English Speakers Tip Sheet (PDF)
• Eligibility Checklist (DOC)
• Informed Consent Documentation Checklist (DOC)
• Informed Consent Elements – Basic and Additional (PDF)
• Informed Consent Tip Sheet (PDF)
• Job Aid – Submitting UH Research Data Extract Request via Workfront (PDF)
• Medical History Template (DOC)
• Off Treatment/Off Study Checklist (DOC)
• Protocol Deviations and Important Protocol Deviations Tip Sheet (PDF)
• Recording Demographics in Clinical Research (PDF)
• Research Recruitment Table Tip Sheet (PDF)
• Serious Adverse Event (SAE) Reporting Form (PDF)
• Study Visit Checklist Template (DOC)

Recruitment & Community Outreach Strategy Consultation

To help ensure the success of your research project, the Clinical Research Center offers complimentary Recruitment & Community Outreach Strategy Consultations to help you reach your goals. These consultations ideally occur prior to IRB submission but can happen at any point in the progression of your research study.

Website landing pages, social media, and digital promotion of your study and can be helpful for recruitment. Request UH Marketing support for creating a web presence for your study or research program by submitting Workfront request to get the process started.

The UH Research Recruitment Toolkit is a compilation of resources to aid in your clinical trial recruitment efforts. Inside you will find guidance, tips, and UH branded templates that can be personalized and used as part of your study recruitment plan.

Download the UH Recruitment Toolkit

• Certification for the Use of Protected Health Information Preparatory to Research (Certification Form) (PDF)
• Internal QA Checklist – Participant (PDF)
• Internal QA Checklist – Regulatory (PDF)
• Monitoring Visit Checklist (Word .doc)
• Study Close Out Checklist (Word .doc)
• Administrative Action Checklist (PDF)
• Preparatory to Research Flowchart (PDF)
• Departing Investigator Checklist - Transfer Study to New UH PI (PDF)
• Departing Investigator Checklist - Transfer Study to New UH PI and Open at Another Institution (PDF)
• Departing Investigator Checklist - Study Closure at UH (PDF)
• Departing Investigator Checklist - Study Closure at UH and Open at Another Institution (PDF)
• FDA Inspection Checklist (PDF)
• Audit Readiness – A Culture of Compliance (PDF)

• Laboratory Regulatory Documents
  • CAP Certificates 
  • CLIA Certificates 
  • Contact Information for Laboratory Documents 
  • Laboratory Sites and Directors 
  • Laboratory Director CV's 
  • Laboratory Reference Ranges (View Only)
  • Laboratory Reference Ranges (Print)
• CWRU Genomics Core

Investigational Drug Service (IDS) Support

The UH Department of Pharmacy Services provides Investigational Drug Service (IDS) support, including procurement, inventory, and dispensing of investigational and non-investigational drugs for research protocols across the UH system. If you are conducting a clinical research study at UH CMC or one or more of our community hospital or ambulatory sites, you will need to ensure that you plan for and understand how your investigational product (IP) will be procured, inventoried, and dispensed considering (consistent with standard operating procedures in compliance with drug storage temperature monitoring, and overall study and IP management oversight) that each site may require different processes to accommodate limitations. See UH System Policy MM-4 Investigational Products and the UH Clinical Research SOP Manual for more information.

Schedule an IDS Consultation

Please send an e-mail to IDS@UHhospitals.org to request an IDS Consultation as you plan for this integral part of your research study.

• Investigational Drug Services Drug or Biologics Service Request Form (Word .doc)
• Investigational Drug Services Fee Waiver Request Form (Word .doc)
• Investigational Drug Services Memo – UHCMC Satellite Participation in IRB Approved Clinical Trials
• Investigational Drug Services Pharmacy Exception Request Form (Word .doc)
• Email to request Investigational Drug Services SOP – Transport and Transport of Study Articles
• Drug Accountability Log (Word .doc)
• Study Drug Transportation Record (Word .doc)
• UH Care New Investigational Drug Submission Form (PDF)
• Investigational Device Billing - Service Catalog Request Contact List (PDF)

TriNetX allows us to query and extract electronic medical record data to assist with research activities such as study feasibility and patient recruitment. Services are available at no cost to UH Principal Investigators and study teams.

• Protocol Feasibility
• De-Identified DATASETS
• Identified Patient Lists

Learn about TriNetX and submit a request

When data requests include data prior to 2015, specific data points and outcomes, or more data elements than available in TriNetX, including identifiable datasets, a Workfront request must be submitted to Research IT. You can submit a request using Workfront under the “Requests” tab.

Note: Research IT staff prioritize prospective clinical trials. Research IT EMR data request option may take from six weeks to six or more months to fulfill due to the existing Research IT request queue and analyst and developer workload. It is recommended that data requests be submitted at the same time that IRB applications are submitted for IRB review.

For additional information, contact ResearchIT@UHhospitals.org.

Download the Research IT Data Request Job Aid