Research Forms & Resource Lists

 

Go to:  IRB Forms      Research Forms (Non-IRB)      Research Resources

 

All requests for expedited and exempt review must be received by the IRB Administrator no later than 5:00 p.m. on Monday to be reviewed within the week.  Requests for expedited and exempt review should be scanned and submitted via email to Stacey Hendricks.  

 

IRB Forms

Description

IRB Submission Check Sheet

To be used for all requests submitted to the IRB (including initial submission, continuing review, adverse event reporting and closing a study); provides listing of all required attachments

Form A: Initial approval

Used for new full board and expedited studies.  The application has a set of questions which must be addressed for the IRB to conduct an adequate review and to comply with federal requirements.  Use the IRB submission check sheet as a guide and final check for preparing and submitting a complete application.

45CFR46.111

Form B:  Exempt request

Used to confirm that full board and/or expedited review are not required.  Confirmation of IRB approval of exempt request may be required for publication.

45CFR46.101(b)

Form C:  Revision change

Required when significant changes are made to the study, including changes in key personnel, revised protocol, consent form, editorial/administrative changes

Form D: Continuing review

IRB review of all studies (initially approved by full board or expedited) is required at intervals appropriate to risk, but not less than once per year (365 days).  Refer to IRB meeting schedule to insure adequate time for review.

45CFR46.109(e)

Form E:  Significant adverse event report

Used to report events reported by sponsor, unexpected adverse events, serious injury or death of a human subject.  Refer to UTCOMC policies and procedures for definition and timeframe for reporting.

Form F:  Final report

Required at the time the study is terminated (ie, no subjects are active or being followed)

Form G:  Advertisement

Required for IRB review of all recruitment/solicitation materials (eg newspaper, posters, website, radio, TV, etc)

Form H:  HIPAA waiver of authorization

Required for access to protected health information (eg, retrospective or prospective chart review) without the subjects consent (this applies to living & deceased patients for electronic and hardcopy records)

45CFR.164

Form I:  Protocol deviation & violation

Used to report a waiver (including exclusion/inclusion criteria) or a deviation from the IRB-approved protocol (eg consent not obtained, drug not given per protocol) (see protocol deviation algorithm in Research Resources)

Documentation of assent in children

Attachment for all consents for children (<18 yrs), whether assent is given or waived

45CFR Subpart D

2012 UT COMC/EHS Model Consent Form

Template for informed consent language, including all elements required by the DHHS, FDA, HIPAA, UTCOMC

45CFR46.116

2012 Spanish short consent form Spanish short form consent and instructions for non-English speaking potential research subjects
2012 English short consent form English translation of the Spanish short consent form

Exempt review categories

Description of research that may not require full board or expedited review.  This determination should be made by the IRB, not the investigator.

45CFR46.101(b)

Expedited review categories

Description of research that presents no more than minimal risk to human subjects and may not require full board review, but may be expedited

45CFR46.110

UTCOM IRB Fee Invoice Invoice to be used, as needed, for fees associated with submission of Form A

 

  

Go to:  IRB Forms      Research Forms (Non-IRB)     Research Resources

 

 

Research Forms (non-IRB)

 Description

Online research office consultation request form

Initial request for research support, including literature review, study design, statistical planning & analysis, grants

UTCOMC grant request form

To be submitted (with detailed project & budget) to seek grant funding

UTHSC contract certification form

Investigator confirmation of contract terms, obligations, etc.

UTHSC routing sheet

Cover sheet to accompany all grant/research submissions

Graphics request form

Request for poster or other research display; IRB approval number required for human subject research or case study

Department Research Review Form 2011.9.7 Department/Program Approval prior to SRC/IRB submission
Erlanger Radiology Research Collaboration Form 20119 Request for Erlanger radiology services to be used in research (i.e., x-ray, nuclear medicine, mammograpy, fluoroscopy, MRI, DEXA, CT, ultrasound, interventional radiology)
Erlanger Pharmacy Research Collaboration Form Request for pharmacy services to be used in research (i.e., storage, blinding, randomization, dispensing of investigational drugs)
Erlanger Pharmacy Investigational Drug Service Fees-2017 Set up and maintenance fees for Erlanger pharmacy services
2014 Erlanger MCA Research Checklist Checklist of required documents to submit for Medicare Coverage Analysis
2011.9 Medicare Coverage Analysis

Required to confirm that a trial qualifies for Medicare to cover reasonable and necessary items and services

Clinical Research Billing Grid 2017

Determines what services are delivered to patient while on clinical trial, who will provide the service, who should be billed
Erlanger Investigator Agreement - Rev 09/2015 Contract language between an investigator and EHS for all prospective trials conducted at Erlanger (including trials that involve only standard of care)
Erlanger Clinical Research Master Agmt UTCOMC, 2012.4.3 Contract language between UT and Erlanger to conduct research
E-Signature Certification Agreement between Erlanger and FDA allowing e-signatures
Clinical Trials Gov ACT Checklist Checklist to determine if Investigator Initiated Trials meet the definition of "Applicable Clinical Trial" and require registration on Clinicaltrials.gov

 

 

 

Research Resources

Description

Grant review timeline

Overview of grant submission process

Research submission timeline

Overview of research submission process

SRC timeline Overview of Scientific Review Committee process
Erlanger Research and Billing Flowcharts Overview for the UTCOMC and EHS IRB and contracting process

UTCOMC protocol deviation algorithm

Overview for timely reporting of protocol deviations, protocol violations, and serious adverse events; see Form I in IRB Forms

Scientific Review Committee proposal format

Outline of project requirements for submission and presentation to the SRC

2016 IRB Membership List

2017 IRB Membership List

List of IRB members, speciality, and affiliation
IRB policies & procedures 2012

UTCOMC Institutional Review Board policies and procedures

Erlanger FWA Erlanger's Federalwide Assurance for the Protection of Human Subjects
Research Manual UTCOMC how-to instructions for new and experienced investigators, mentors, and support staff

Tools for multi-site research

Resources and tools used in other research networks covering collaborations, proposal development, study start-up, study conduct, study closure, and resources for training.

Qualtrics Link to information about Qualtrics, a web-based survey service that is available to all UTHSC faculty, staff, and students.

 

 

Go to:  IRB Forms      Research Forms (Non-IRB)     Research Resources

 

 

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