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)
- 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)
- Subject Management Tools
- 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)
- Site Initiative 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)
- Lab Tools
- Investigational Drug Tools
- 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)
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.
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.
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).