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Indiana University
Research Compliance Quarterly 6th Edition (Corrected)
April 8th, 2016
Comply with Me - Making it easy to do it right, and hard not to do it right
In this issue:
KC IRB Updates
  • ➺ The HSO has updated two smart forms (KC IRB questionnaires):
  • Updates to Questionnaire B – Lay Summary & Research Design include revised wording and a new question to better elicit funding details, as well as new multiple choice question options to clearly identify clinical studies in partnership with the OnCore efforts by the Clinical Trials Office. This questionnaire is a required component for protocols requiring Expedited or Full Board review, unless the protocol has an approved version of the previous HSO form: Summary Safeguard Statement.
  • Completion of the revised questionnaire is required for New Studies and Renewals submitted on or after March 31, 2016.
  • For renewals due after March 31, create a ‘Renewal with Amendment’ and select Questionnaire B to amend.
  • Renewals will be Returned to PI if:
  • Questionnaire B was not selected to amend when submitting a Renewal with Amendment; or.
  • A Renewal only (without Amendment) was submitted.
  • Studies approved pre-KC IRB Questionnaire functionality (pre-July 31, 2014) have no action required.
  • For more information regarding the OnCore initiative, click here.
  • Updates to the Request to Defer IU IRB Review questionnaire include revised wording, new questions, and new multiple choice question options to clearly identify clinical trials in partnership with the OnCore efforts by the Clinical Trials Office. This questionnaire is a required component for protocols submitted as a Deferral type in KC IRB.
New Education Requirement Begins July 1, 2016

The training display of PI and Co-PI on the Personnel tab has been adjusted to now account for Good Clinical Practices (GCP) CITI training (if required and missing). GCP training will be required beginning on July 1, 2016 for interventional clinical studies. The current display is simply a warning. The IRB will take no action on missing GCP training until studies submitted on or after July 1, at which time GCP training will be a condition of IRB approval. The NIH's National Center for Advancing Translational Sciences (NCATS) is leading an initiative to promote Good Clinical Practice (GCP) training to ensure that all investigators who conduct clinical trials are appropriately trained. Indiana CTSI supports this training initiative as an essential step toward further ensuring the protection of trial participants and the quality of clinical trial results.

Human Subjects Office Teams (Corrected Phone Numbers)

Did you know that the Human Subjects Office is divided into 3 teams to process all human subjects’ studies that come into our office from throughout IU, IU Health and Roudebush Veteran’s Hospital? Every Department and the VA has a dedicated Research Consultant or Associate to process and provide assistance with their submissions with the IRB. Below is a list of Teams, their Departments and telephone numbers so if you have a question about your study and where it is – now you know who to call:

Team 1

Bethany Johnson - Associate Director (317) 278-7831
Kara Brocious (317) 278-7814
Michele Garvin (317) 278-7810
Danielle Giltner (317) 278-1044
Ryan Howell (317) 278-5445
Heather Mullins-Owens (317) 278-5453
Avril Pitt (317) 278-5455
Sherri Ream (317) 274-5518
Sara Weiss (317) 274-7930


Adolescent MedicineCritical Care/AllergyDevelopmental Peds
Infectious DiseasesNeonatologyNephrology
OB/GYNPeds Health ServicesPeds Hem/Onc
Peds Hosp. Med.Peds Stem Cell TrspltPulmonary
Radiation OncologyRheumatologyUrology

Team 2

Amy Waltz - Associate Director (317) 278-5431
Kelly Anderson (317) 278-2310
Lainna Cohen (317) 274-2161
Eric Felde (317) 278-7816
Maggie French (317) 278-7811
Leslie Patton (317) 278-7813
Kimberly Smith (317) 278-7812
Brian Stage (317) 278-6517


AnesthesiaBiostatsCardiology (even Peds)
Clinical PharmacologyDentistry/Oral HealthDermatology
Emergency MedicineFamily MedicineGeneral Surgery
Health/Rehab SciencesInternal MedicineIUSM Regionals
Medical/Molecular GeneticsMicrobiology/ImmunologyNeurology
PathologyPharmacyPhysical Med/Rehab
Plastic SurgeryPsychiatryRadiology
Surgery (even Peds)Transplant SurgeryVascular Surgery

Team 3

Sara Benken - Associate Director (812) 856-3753
Senta Baker (812) 855-0945
Adam Mills (812) 856-4687
Sharon Moran (812) 856-7357
Casey Mumaw (812) 855-1741
Andrew Neel (812) 856-2487


Administrative OfficesApplied Health ScienceArts & Humanities
Bioethics Campus Recr. SportsCtr For Eval & Educ Policy
Ctr for Urban PolicyCtrs for Philanthropy College of Arts & Science
Continuing StudiesCriminal JusticeEconomics
Environmental HealthEpidemiologyGender Studies
Geography Global & Int'l Progr Herron Sch of Art & Des
Jacobs School of Music Kelley School of BusKinsey Institute
Maurer School of LawMedical Sciences Natural & Math Science
Political Science Psych & Brain SciPsychology
Purdue School of Science McKinney Law School of Eng & Tech
School of EducationSchool of Informatics School of Info & Comp
School of JournalismSchool of Liberal Arts School of Lib & Info Sci
School of Phy Ed & Tour Mgmt School of Pub HealthSchool of Social Work
Social & Historical Sciences Speech & Hearing ScienceTelecommunications

All Veteran's Administration Studies - All Teams

Rick Erny (317) 278-3137
AAALAC Site Visit

Last month, the Indiana University Bloomington campus hosted site visitors from the Association for Assessment and Accreditation of Laboratory Animal Care, International ("AAALAC"). We appreciate the time, effort, and cooperation of researchers and staff that made this a successful visit.

The site visitors conducted an in-depth evaluation of the Bloomington campus animal care and use program. The formal recommendation of the site visitors will be made to the AAALAC Council in May; however, many compliments were shared at the exit briefing and the program was noted to be a very high functioning one. The site visitors left with a few suggestions that the program will be reviewing, while they observed a strong administrative commitment to the animal care and use program, engagement of the IU Bloomington Institutional Animal Care and Use Committee, and an excellent team approach across all parts of the university.

IU Bloomington first received accreditation in 2014, and the IU School of Medicine's program was recently re-accredited last year in 2015. AAALAC is a voluntary accrediting organization that enhances the quality of research, teaching and testing by promoting humane, responsible animal care and use. It provides advice and independent assessments to participating institutions and accredits those that meet or exceed applicable standards by conducting site visits every three years.

Quality Improvement Office Resources for Study Compliance

Not surprisingly, the most effective approach to ensure readiness for an audit – conducted either by IU’s Quality Improvement Office (part of the IU Office of Research Compliance) or by an external entity such as a sponsor or federal agency – is two-fold: (1) establish compliant practices from the beginning of the study and (2) periodically self-audit to verify their continued conduct. Establishing baseline compliance can be accomplished in part by appropriately designing your study documents prior to study initiation. For example, ensuring that your source and case report form templates (including study data logs for tracking screening or enrollment, investigational product accountability, and study incidents such as adverse events or protocol deviations) contain all fields necessary to confirm adherence with federal and local requirements will help promote compliance as the form is completed.

Periodic self-auditing can then be accomplished through either internal or external review of source and CRF for accuracy, completion, and thoroughness (i.e., self-check of your work or review of your work by another team or department member). These periodic checks often vary with regard to frequency of occurrence and extent of data reviewed; however, the identification of issues is commonly recognized as a reason to increase either the frequency and/or the extent of the auditing activities. Also, although additional resources may be limited within your study team, review by an individual who – at a minimum – did not complete the task/form under review is considered the gold-standard as self-review is known to hinder objective detection of errors.

QIO’s website provides a variety of recently updated templates to assist study teams with both form development and self-auditing. These include an example Table of Contents for your Regulatory Binder; informed consent/assent process documentation notes specific to initial consent, reconsent, and for situations that require use of a guardian or LAR in the consent process; adverse event and protocol deviation tracking logs which incorporate IU’s criteria for prompt reporting; as well as self-audit worksheets for your regulatory binder, drug or device accountability, and subject charts. Templates may be downloaded and revised for your specific study’s needs.

Suggestions for additional tool or template development can be submitted to the QIO office directly at (researchqio@iu.edu).

ClinicalTrials.gov Record and FDA Inspection

The Office of Research Compliance, along with the Clinical and Translational Sciences Institute (CTSI), participates in the national CTSA ClinicalTrials.gov Taskforce. During a meeting, a non-Indiana University institution discussed a recent clinical research FDA inspection that identified discrepancies between the IRB approved protocol and ClinicalTrials.gov record. This information provided evidence that the FDA is adding ClinicalTrials.gov compliance to the elements included in its clinical research auditing. Additional information about the FDA inspection’s post-meeting and findings may be provided at a later date.

ClinicalTrials.gov Training

The Office of Research Compliance, along with the Clinical and Translational Sciences Institute (CTSI), is offering training on the ClinicalTrials.gov, Protocol Registration and Results system.

Please reserve your spot by visiting the University-wide Research Education Sessions & Registration class schedule. To view training opportunities, select "Quality Improvement Office" in the "List classes for Area" drop-down.

Course Name: ClinicalTrials.gov Results Module Training
Focus: Preparing for results reporting, results reporting entry
Date: 4/14/2016
Time: 2-4:00 PM
Location: Indianapolis, Lockefield (LV) 3301

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