Pdf toolbox clinical manual#
Pdf toolbox clinical software#
Pdf toolbox clinical trial#

Email to request Investigational Drug Services SOP – Transport and Transport of Study Articles.Investigational Drug Services Pharmacy Exception Request Form (Word.Investigational Drug Services Memo – UHCMC Satellite Participation in IRB Approved Clinical Trials.Investigational Drug Services Fee Waiver Request Form (Word.Investigational Drug Services Drug or Biologics Service Request Form (Word.

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

Pdf toolbox clinical manual#

See UH System Policy MM-4 Investigational Products and the UH Clinical Research SOP Manual for more information. 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. 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. Investigational Drug Service (IDS) Support Laboratory Reference Ranges (View Only).Contact Information for Laboratory Documents.Audit Readiness – A Culture of Compliance (PDF).

Microsoft Identity Manager Guide for Monitoring Access to the EMR (PDF).

Departing Investigator Checklist - Study Closure at UH and Open at Another Institution (PDF).

Departing Investigator Checklist - Study Closure at UH (PDF).

Departing Investigator Checklist - Transfer Study to New UH PI and Open at Another Institution (PDF).

Departing Investigator Checklist - Transfer Study to New UH PI (PDF).

Preparatory to Research Flowchart (PDF).

Internal QA Checklist – Regulatory (PDF).

Internal QA Checklist – Participant (PDF).

Certification for the Use of Protected Health Information Preparatory to Research (Certification Form) (PDF).

Pdf toolbox clinical software#

Allscripts Letter Describing 21 CFR Part 11 Software Compatibility (PDF).

Inside you will find guidance, tips, and UH branded templates that can be personalized and used as part of your study recruitment plan.

Pdf toolbox clinical trial#

The UH Research Recruitment Toolkit is a compilation of resources to aid in your clinical trial recruitment efforts. These consultations ideally occur prior to IRB submission but can happen at any point in the progression of your research study. 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. Recruitment & Community Outreach Strategy Consultation Job Aid – Submitting UH Research Data Extract Request via Workfront (PDF).Off Treatment/Off Study Checklist (Word.Serious Adverse Event (SAE) Reporting Form (PDF).Protocol Deviations and Important Protocol Deviations Tip Sheet (PDF).Recording Demographics in Clinical Research (PDF).Informed Consent Elements – Basic and Additional (PDF).Informed Consent Documentation Checklist (Word.Building an eConsent Documentation Tool in REDCap (PDF).Alternative Wording for Consent Documents (PDF).Authorization for Release of Medical Information (PDF).Acronym Expansions (Dotphrases) for Clinical Research (PDF).Versions in Clinical Research Tip Sheet (PDF).UH-Researcher-Cold-Storage-Reference (PDF).Site Initiation Visit Slide Presentation Template (PPTX).Site Initiation Visit Checklist (Word.Iron Mountain Process Checklist using ONCORE (PDF).Electronic Certified Copy Attestation (PDF).Delegation of Authority Log/Staff Signature Log (Word.Corrective and Preventative Action Plan (Word.External Adverse Event Summary log (Excel.Internal Adverse Event Summary log (Excel.Regulatory Binder Template and Tabs (PDF).Supporting UH Research through Social Media (PDF).Research Billing Patient Visit Flowchart (PDF).