Clinical Research Toolbox
Tools & Resources
- Educational Tools
- Regulatory Binder Kit
- Regulatory Binder Files Index (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)
- Study Management Tools
- Subject Management Tools
- Authorization for Release of Medical Information (PDF)
- Alternative Wording for Consent Documents (PDF)
- Eligibility Checklist (Word .doc)
- Informed Consent Documentation Checklist (Word .doc)
- Informed Consent Elements – Basic and Additional (PDF)
- Off Treatment/Off Study Checklist (Word .doc)
- Job Aid - Submitting UH Research Data Extract Request via Workfront (PDF)
- Recruitment Toolkit
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.
- Compliance Tools
- Allscripts Letter Describing 21 CFR Part 11 Software Compatibility (PDF)
- 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)
- Microsoft Identity Manager Guide for Monitoring Access to the EMR (PDF)
- UHCare Access Request Form (PDF)
- Creating a Patient List from EMR (PDF)
- Lab Tools
- Investigational Drug Services and Tools
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)
UH Research Roadmap
Need a guiding hand? The UH Research Roadmap (PDF) will help you successfully navigate the research process in even greater detail directing you to specific regulations, policies, forms, tools, templates, contact points, education and training that you’ll need along the way. Use the Roadmap as a checklist for every study to make sure that all of your bases are covered as you move through the research process.
Clinical Research Checklist
Getting started with Clinical Research Checklist for New Researchers, Residents, Fellows & Students (PDF) is also useful document for new investigators wanting to do research.
Clinical Research Data Requests
University Hospitals Clinical Research Center has partnered with TriNetX to provide new research opportunities to investigators and assist with recruitment challenges.
TriNetX allows us to more effectively 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
- Research IT EMR Data Requests
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.
UH CRC Research Study Database
The UH CRC Research Study Database was developed to streamline and standardize the processes required to manage a research project at UH and to improve efficiency. Electronic study start up forms to help facilitate a faster process and eliminate redundancy, the ability to post enrolling studies on the website, screening and enrollment metrics, electronic tracking of RBNFs, and more are all available within the database. Download the UH CRC Research Study Database User Guide (PDF).
Clinical Research Community Advisory Board
Do you have a question about how to best engage clinical trial participants? Are you looking for more ways to improve the clinical trial patient experience? Could you benefit from candid feedback about an effective way to disseminate clinical trial results? The Clinical Research Community Advisory Board is a perfect place for feedback from past and prospective clinical trial participants and healthcare consumers.
Submit a question, issue, or project for consideration for an upcoming meeting by sending an e-mail to: ClinicalResearchCAB@UHhospitals.org.